Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.
Serratus Anterior Plane Block in Patients Undergoing Mastectomy
This is a randomized, interventional prospective study. Patients (n=66) undergoing
mastectomies with or without tissue expander will be randomized to receive a supra-serratus
or sub-serratus regional plane block prior to surgery. The main effect to be measured is
total opioid consumption 24 hours after the operation. Secondary endpoints include measuring
a change between pre-and post-operative pain scores, patient satisfaction of pain control
during first 24 hours after the operation, presence of postoperative nausea and vomiting,
duration of sleep on first postoperative night, and block performance time and length of
stay, between the two treatment arms.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Anthony Machi
159003
All
18 Years and over
Phase 4
This study is NOT accepting healthy volunteers
NCT03154658
STU 122016-011
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Inclusion Criteria:
1. Adult patients 18 years or older
2. Individuals undergoing either a mastectomy or mastectomy with tissue expander for
which the anesthetic plan includes a serratus anterior plane block.
Exclusion Criteria:
1. Any known sensory deficit of the anterolateral chest wall.
2. Any local disorder of the skin or otherwise where blockade is to be performed which
would prevent safe performance of the block
3. Pregnancy
4. American Society of Anesthesiology classification greater than 3
5. Allergy to amide local anesthetic medications
6. Chronic pain conditions
7. Preoperative opioid use greater than 20 oral morphine equivalents per day
8. Any coagulation abnormality which would be a contraindication for block placement
9. Preoperative chronic renal dysfunction requiring renal replacement therapy or a serum
creatinine greater than 1.4 mg/dL
10. Body mass index >50
11. Incarceration
12. Inability to understand study procedures including inability to understand the English
language
13. Inability to provide adequate informed consent
14. Refusal to participate in the study
Epidural and Intravenous Patient-Controlled Analgesia Following Lumbar Spinal Fusion Surgery
Postoperative analgesia following spine surgery is difficult to manage. Current treatment
modalities rely heavily on opioid analgesics with all of the inherent limitations and side
effects. While current best practice focuses on a 'multimodal approach' (i.e. using multiple
different drugs and techniques to control pain after surgery), there is no consensus
regarding which components of this multimodal therapy provide optimal analgesia. This
prospective randomized study will enroll patients undergoing elective Lumbar Spinal Fusion
Surgery at Zale Lipshy University Hospital. The primary objective is to determine the
comparative efficacy of epidural analgesia, as compared with intravenous (IV)
patient-controlled analgesia (PCA), on post-operative analgesia.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Enas Kandil
74036
All
18 Years to 80 Years old
Phase 4
This study is NOT accepting healthy volunteers
NCT03115151
STU 092016-061
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Inclusion Criteria:
• Adult subjects aged 18 years or older
• Scheduled for elective posterior lumbar spinal fusion surgery between 1 and 3 levels
Exclusion Criteria:
• Baseline cognitive deficits sufficient to make objective pain self-assessments
unreliable in the estimation of the Study Investigators.
• Immunocompromised subject
• Coagulopathy
• Severe liver and renal dysfunction
• Preoperative neurological deficits
• The dura damage during surgery
• Inability to follow directions or comprehend the English language.
• Females who are pregnant as determined by positive pregnancy test on or before the day
of surgery.
• Prisoners.
• Patient refusal to provide informed consent.
• Allergy to amide local anesthetics (lidocaine, bupivacaine, ropivacaine) or opioid
(fentanyl) allergy if patient assigned epidural analgesia.
• Hydromorphone allergy if patient assigned IV PCA
Standard of Care Therapy With or Without Stereotactic Radiosurgery and/or Surgery in Treating Patients With Limited Metastatic Breast Cancer
This randomized phase II/III trial studies how well standard of care therapy with
stereotactic radiosurgery and/or surgery works and compares it to standard of care therapy
alone in treating patients with breast cancer that has spread to one or two locations in the
body (limited metastatic) that are previously untreated. Standard of care therapy comprising
chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread of
tumor cells. Radiation therapy and/or surgery is usually only given with standard of care
therapy to relieve pain; however, in patients with limited metastatic breast cancer,
stereotactic radiosurgery, also known as stereotactic body radiation therapy, may be able to
send x-rays directly to the tumor and cause less damage to normal tissue and surgery may be
able to effectively remove the metastatic tumor cells. It is not yet known whether standard
of care therapy is more effective with stereotactic radiosurgery and/or surgery in treating
limited metastatic breast cancer.
• Pathologically confirmed metastatic breast cancer
• Known estrogen, progesterone, and HER2 status of either primary tumor or metastasis
• ≤ 4 metastases seen on standard imaging within 60 days prior to registration when all
metastatic disease is located within the following sites:
• peripheral lung
• osseous (bone)
• spine
• central lung
• abdominal-pelvic(lymph node/adrenal gland)
• liver
• mediastinal/cervical lymph node
• All known disease amenable to metastasis-directed therapy with either SBRT or
resection
• NOTE: Symptomatic bone metastasis are allowed if ablative therapy can be
delivered
• NOTE: Sites for possible surgical excision include lung, liver, adrenal gland,
bone, small intestine, large intestine, ovary, and amenable nodal disease sites
• NOTE: Surgical stabilization is allowed for a metastasis if it is followed by
conventionally fractionated external beam radiotherapy
• Maximum diameter of individual metastasis in any dimension ≤ 5 cm
• There are no restrictions on distance between the metastases
• Patients must be registered within 365 days of the initial metastatic breast cancer
diagnosis. First-line standard systemic therapy (chemotherapy, anti-endocrine therapy,
anti-HER2 or other standard targeted therapy) for metastatic breast cancer must be
given or planned to be given. If given before study entry, it cannot have exceeded a
duration of 12 months at the time of registration. (Note: Sequencing of ablative
therapy (surgery or SBRT) relative to systemic therapy, for patients randomized to Arm
2, is at the discretion of the treating physician.)
• The primary tumor site must be controlled prior to registration
• For those who present with synchronous primary and oligometastatic disease:
Primary must be controlled prior to registration. The definition of control is definitive
surgery by excision or mastectomy (+/- radiotherapy) per institution preference
• For those who present with local recurrence and oligometastatic disease, local
recurrence must be controlled prior to registration The definition of control is
definitive surgery by excision or mastectomy (+/- radiotherapy) per institution
preference
• Appropriate stage for study entry based on the following diagnostic workup:
• History/physical examination within 60 days prior to registration
• Clinical grade computed tomography (CT) scans of the chest, abdomen, and pelvis with
radionuclide bone scan OR whole body positron emission tomography (PET)/CT within 60
days prior to study registration
• Zubrod performance status ≤ 2 within 60 days prior to registration
• Absolute neutrophil count (ANC) ≥ 500 cells/mm^3
• Platelets ≥ 50,000 cells/mm^3
• Hemoglobin ≥ 8.0 g/dl (note: the use of transfusion or other intervention to
achieve hemoglobin [Hgb] ≥ 8.0 g/dl is acceptable)
• For females of child-bearing potential, negative serum or urine pregnancy test
within 14 days prior to study registration
Exclusion Criteria:
• Pathologic evidence of local/regional breast tumor recurrence at the time of
registration
• Co-existing or prior invasive malignancy (except non-melanomatous skin cancer), unless
disease free for a minimum of 3 years; previous RT dose, date, fraction size, must be
reported
• Metastases with indistinct borders making targeting not feasible
• NOTE: A potential issue with bone metastases is that they often are not discrete.
Since many patients on this protocol will have bone metastases, this will be an
important issue. Theoretically, Houndsfield units might provide an appropriate
measure; however, a sclerotic lesion against dense cortical bone will not have a
sharp demarcation based on Houndsfield units (HU). Therefore, we acknowledge that
such determinations will pose a challenge and thus the physician's judgment will
be required
• Prior palliative radiation treatment for metastatic disease (including
radiopharmaceuticals)
• Metastases located within 3 cm of the previously irradiated structures:
• Spinal cord previously irradiated to > 40 Gy (delivered in ≤ 3 Gy/fraction)
• Brachial plexus previously irradiated to > 50 Gy (delivered in ≤ 3 Gy/fraction)
• Small intestine, large intestine, or stomach previously irradiated to > 45 Gy
(delivered in ≤ 3 Gy/fraction)
• Brainstem previously irradiated to > 50 Gy (delivered in ≤ 3 Gy/fraction)
• Whole lung previously irradiated with prior V20Gy > 30% (delivered in ≤ 3
Gy/fraction)
• Primary tumor irradiated with SBRT
• Metastasis irradiated with SBRT
• Brain metastases
• Exudative, bloody, or cytological proven malignant effusions
• Severe, active co-morbidity defined as follows:
• Unstable angina and/or congestive heart failure requiring hospitalization within
the last 6 months
• Transmural myocardial infarction within the last 6 months
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time
of registration
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy at the time of registration
• Pregnancy; lactating females must cease expression of milk prior to signing consent to
be eligible
• Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4
count < 200 cells/microliter; note that patients who are HIV positive are eligible,
provided they are under treatment with highly active antiretroviral therapy (HAART)
and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration; note
also that HIV testing is not required for eligibility for this protocol
ANI Versus Standard Care in Surgical Patients Receiving Balanced Sevoflurane-Fentanyl Anesthesia
This study aims to be a randomized, controlled study of ANI-guided opioid administration
versus standard clinical practice in surgical patients undergoing general anesthesia with
balanced sevoflurane-fentanyl. Patients will be randomly assigned to 2 groups- ANI vs.
standard care. The intraoperative and postoperative management of all patients will be
standardized by protocol. The PACU nurses and postop assessor will be blinded as to which
group the patient is in.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Tiffany Moon
66760
All
18 Years to 75 Years old
N/A
This study is also accepting healthy volunteers
NCT03684590
STU-2018-0096
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Inclusion Criteria:
• 18-75 years old
• ASA 1-2
• BMI 19-35 kg/m2
• Patients undergoing surgery with general anesthesia with sevoflurane- fentanyl
• Planned abdominal or spinal surgery lasting 1-3 hours
• Willing and able to consent in English or Spanish
• No current history of advanced pulmonary or cardiovascular disease
Exclusion Criteria:
• Age less than 18 or older than 75
• Patient does not speak English or Spanish
• Patient refusal
• Monitored anesthesia care (MAC) or regional anesthesia planned
• Pregnant or nursing women
• "Stat" (emergent) cases
• ECG rhythm other than regular sinus rhythm
• Implanted pacemakers
• On antimuscarinic agents, alpha 2 agonists, antiarrhythmics, or beta blockers
• Presence of pacemaker
• Autonomic nervous system disorder
• Use of chronic opioids
Device: ANI-guided opioid administration, Other: Standard opioid administration
Interscalene Bupivacaine With Either Liposomal Bupivacaine or Continuous Peripheral Nerve Block for Shoulder Arthroscopy
This investigation will be a prospective, randomized trial. The study population will consist
of adult patients scheduled to undergo major shoulder arthroscopy procedures with
anesthesiology at the Ambulatory Services Center (Outpatient Surgery Center). Forty-six
subjects will be enrolled in this study and will be randomized into one of two arms: 1)
Single-injection bupivacaine HCl plus a subsequent bupivacaine CISB, 2) Single-injection
bupivacaine HCl plus liposomal bupivacaine included in the same injection. These procedures
will take place, using an ultrasound-guided method, approximately one hour prior to surgical
procedure. Subjects will be followed for seven days to assess pain control by the Modified
Brief Pain Inventory (MBPI) survey and outcome factors related to study and procedure using
the American Shoulder and Elbow Surgeon Shoulder Score (ASES Shoulder Score).
Call 214-648-5005 studyfinder@utsouthwestern.edu
Anthony Machi
159003
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03816982
STU 082018-017
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Inclusion Criteria:
• Adult patients ≥ 18 years
• Individuals presenting for major shoulder arthroscopy procedures at Ambulatory
Services Center (Outpatient Surgery Center) (for example: rotator cuff repair,
subacromial decompression, Bankart repair)
• Patient is able to provide informed consent to participate in the study.
Exclusion Criteria:
• Allergy to amide local anesthetic, liposomal bupivacaine or other medication involving
liposomal formulation
• Preexisting neurological deficits involving or potentially involving the ipsilateral
brachial plexus
• Preexisting contralateral vocal fold paralysis or recurrent laryngeal paralysis
• Psychiatric or cognitive disorders that could interfere with perioperative evaluation
including drug or alcohol abuse
• Chronic pain conditions
• Preoperative opioid consumption greater than 20 mg oral morphine equivalent.
• Any contraindication to interscalene nerve block including any local disorder of the
skin where blockade is to be performed which would prevent safe performance of the
block
• Any coagulation abnormality which would be a contraindication for block placement
• Preoperative chronic renal dysfunction requiring renal replacement therapy or a serum
creatinine greater than 1.4 mg/dL
• Body mass index >50
• Pregnancy
• Incarceration
• ASA classification greater than 3
• Inability to provide informed consent
• Refusal to participate in the study
• Patients undergoing biceps tenodesis (due to variable axillary pain not covered by
ISB)
Procedure: Single-injection bupivacaine HCl plus liposomal bupivacaine, Procedure: Single-injection bupivacaine HCl plus a subsequent bupivacaine CISB
A Study to Compare the Long-term Outcomes After Two Different Anaesthetics (TREX)
There is considerable evidence that most general anaesthetics modulate brain development in
animal studies. The impact is greater with longer durations of exposure and in younger
animals. There is great controversy over whether or not these animal data are relevant to
human clinical scenarios.
The changes seen in preclinical studies are greatest with GABA agonists and NMDA antagonists
such as volatile anaesthetics (eg sevoflurane), propofol, midazolam, ketamine, and nitrous
oxide. There is less evidence for an effect with opioid (such as remifentanil) or with alpha
2 agonists (such as dexmedetomidine).
Some, but not all, human cohort studies show an association between exposure to anaesthesia
in infancy or early childhood and later changes in cognitive tests, school performance or
risk of developing neurodevelopmental disorders. The evidence is weak due to possible
confounding.
A recent well designed cohort study (the PANDA study) comparing young children that had
hernia repair to their siblings found no evidence for a difference in a range of detailed
neuropsychological tests. In that study most children were exposed to up to two hours of
anaesthesia. The only trial (the GAS trial) has compared children having hernia repair under
regional or general anesthesia and has found no evidence for a difference in neurodevelopment
when tested at two years of age. The GAS and PANDA studies confirm the animal data that short
exposure is unlikely to cause any neurodevelopmental impact.
The impact of longer exposures is still unknown. In humans the strongest evidence for an
association between surgery and poor neurodevelopmental outcome is in infants having major
surgery. However, this is also the group where confounding is most likely.
The aim of our study is to see if a new combination of anaesthetic drugs results in a better
long-term developmental outcome than the current standard of care for children having
anaesthesia expected to last 2 hours or longer.
Children will be randomised to receive either a low dose
sevoflurane/remifentanil/dexmedetomidine or standard dose sevoflurane anaesthetic.
They will receive a neurodevelopmental assessment at 3 years of age to assess global
cognitive function.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Peter Szmuk
80418
All
up to 2 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03089905
STU 052017-065
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Inclusion Criteria:
• Younger than 2 years (chronological age)
• Scheduled for anaesthesia that is expected to last at least 2 hours (and/or total
operating room time is scheduled to be at least 2.5 hours)
• Has a legally acceptable representative capable of understanding the informed consent
document and providing consent on the participant's behalf.
Exclusion Criteria:
• Known neurologic, chromosomal or congenital anomaly which is likely to be associated
with poor neurobehavioural outcome
• Existing diagnosis of behavioural or neurodevelopmental disability
• Prematurity (defined as < 36 weeks gestational age at birth)
• Birth weight less than 2 kg.
• Congenital cardiac disease requiring surgery
• Intracranial neurosurgery and intracranial craniofacial surgery (isolated cleft lip is
not an exclusion)
• Previous cumulative exposure to general anaesthesia exceeding 2 hours
• Planned future cumulative exposure to anaesthesia exceeding 2 hours before the age of
3 years.
• Any specific contra-indication to any aspect of the protocol
• Previous adverse reaction to any anaesthetic
• Circumstances likely to make long term follow-up impossible
• Living in a household where the primary language spoken at home is not a language in
which we can administer the Wechsler Preschool and Primary School Intelligence Scale
• Planned postoperative sedation with any agent except opioids (e.g. benzodiazepines,
dexmedetomidine, ketamine, barbiturates, propofol, clonidine, chloral hydrate, and
other non-opioid sedatives). For example if such sedation is planned for
post-operative ventilation
Patients undergoing open total abdominal hysterectomy (n=82) at Parkland Memorial Hospital
will be randomized into one of two groups to receive either ultrasound-guided bilateral ESP
block with liposomal bupivacaine (Group 1) or ultrasound-guided bilateral QL block with
liposomal bupivacaine (Group 2) for postoperative pain management. The remaining aspect of
perioperative care, including the general anesthetic technique and postoperative care will be
standardized and will be similar for all patients. The duration of the involvement in the
study will be until 72 hours postoperatively. Anesthesia providers will identify potential
subjects during their Pre-Anesthesia Evaluation Clinic visit and/or Day Surgery Unit
pre-anesthetic assessment. There will be no incentive or payment to the patients.
Patients in Group 1 will receive ultrasound-guided bilateral ESP block in the preoperative
holding area prior to surgery. Patients in Group 2 will receive ultrasound-guided QL block in
the preoperative holding area prior to surgery. All patients will have general anesthesia per
previously established Parkland Enhanced Recovery After Surgery (ERAS) protocols.
Postoperatively, patients in both Groups will receive acetaminophen 1000 mg orally every 8
hours, meloxicam 15 mg orally every 24 hours, and immediate-release oxycodone 5 - 10mg orally
every 4 hours as needed for breakthrough pain.
The postoperative analgesia will be documented using the Numeric Rating Scale (0-10 scale
where 0=no pain and 10=worst pain). In addition, total opioid dose over the 72-hours study
period will be documented. Postoperative nausea will be measured using a categorical scoring
system (none=0, mild=1, moderate=2, severe=3) and episodes of vomiting will be documented.
Rescue anti-emetics will be given to any patient who complains of nausea and/or vomiting. All
variables will be assessed at 4, 6, 12, 24, 48, and 72 hours, postoperatively by an
investigator blinded to group allocation.
Call 214-648-5005 studyfinder@utsouthwestern.edu
John Alexander
52265
Female
18 Years to 80 Years old
N/A
This study is also accepting healthy volunteers
NCT04074226
STU-2019-1174
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Inclusion Criteria:
• Female ASA physical status 1-3 scheduled for open abdominal hysterectomy
• Age 18-80 years old
• Able to participate personally or by legal representative in informed consent in
English or Spanish
Exclusion Criteria:
• History of relevant drug allergy
• Age less than 18 or greater than 80 years
• Chronic opioid use or drug abuse
• Active use of anticoagulant medication
• Significant psychiatric disturbance
• Inability to understand the study protocol
• Refusal to provide written consent
The Effectiveness of Aromatherapy in an Urban, Safety-Net Hospital on Pain
The purpose of this project is to evaluate the effectiveness of aromatherapy on reducing pain
in the acute care setting at Parkland Health and Hospital System. The target population for
this study will be patients who are recovering from surgical procedures and are in the
Surgical Services inpatient units.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Justin Buchert
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT04840212
STU-2020-1176
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Inclusion Criteria:
A) For the current study group:
• Inpatients, 18 years and older, admitted to a surgical service inpatient unit and who
are experiencing pain and/or anxiety, and
• No history of chronic pain, respiratory problems, asthmas, allergies, or lost sense of
smell, and
• Provide informed consent to participate in the study, and
• Complain of pain and anxiety in the 72 hours after surgery or intervention and
requiring PANX.
B) For the historical control group:
• Patients from the same time in the previous year with the same inclusion and exclusion
criteria.
Exclusion Criteria:
A) For the current study group:
• Patients with known allergies or sensitivities to aromatherapy products.
• Lack of interest in participating in or subsequent withdrawal from the research.
• Patients who are intubated, have died, or had serious disease complications will also
be excluded from the study time period and previous year historical control group.
Subject withdrawal from the Study
• Patients who develop allergic symptoms while the aromatherapy patch is applied.
• Patients who require intubation or critical interventions during their
hospitalization.
B) For the historical control group:
• Anyone who does not meet the inclusion criteria
Peripheral Nerve Stimulation(PNS) for Subacromial Impingement Syndrome(SIS)
Shoulder pain accounts for 16% of all musculoskeletal complaints in the healthy adult
population. Subacromial impingement syndrome (SIS) is the most common cause of shoulder pain.
Many patients with chronic pain from subacromial impingement syndrome (SIS) will fail
treatment efforts and have longstanding pain. This project will evaluate the efficacy of a
novel approach to treatment, percutaneous peripheral nerve stimulation, for participants with
chronic shoulder pain due to subacromial impingement syndrome (SIS).
Call 214-648-5005 studyfinder@utsouthwestern.edu
Nitin Jain
186541
All
21 Years to 100 Years old
N/A
This study is also accepting healthy volunteers
NCT03752619
STU-2020-0352
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Inclusion Criteria:
1. Shoulder pain of >3 months
2. Age>=21
3. Worst pain in the last week>=4 (0-10 scale)
4. Ability to check skin and perform dressing changes, independently or with assistance
5. Stable dose of pain medication (Not taking more than than 1 opioid or 1 non-opioid
analgesic)
Exclusion Criteria:
1. Current shoulder joint or overlying skin infection, or current bacterial infection
requiring antibiotics
2. Other chronic pain syndrome (Pain in another area of the body 15 or more days in the
last 30 (more than half of the time) or taking daily analgesics for another pain
syndrome)
3. Prior shoulder surgery to ipsilateral shoulder joint (glenohumeral, rotator cuff,
acromioclavicular (AC) Joint, etc.)
4. Corticosteroid injection in the ipsilateral shoulder or any other pain relieving
treatment in last 12 weeks
5. Uncontrolled bleeding disorder
6. Medical instability based on physician opinion after review of medical information
7. Pregnancy
8. Neurological condition affecting ipsilateral upper limb (such as central neurologic
injury/illness, radiculopathy, diabetic amyotrophy, Complex Regional Pain Syndrome,
etc.)
9. Current Worker's compensation claim for the ipsilateral shoulder
10. Shoulder instability, severe glenohumeral osteoarthritis(OA) based on patient symptoms
and physical examination
11. Ipsilateral shoulder injury due to severe trauma (Fall from greater than standing
height; Motor vehicle crashes; Struck by vehicle or other fast-moving projectile
(e.g., bullet, baseball, etc.); Assault (i.e., injuries intentionally inflicted by
another person))
12. Current osseus fracture in ipsilateral arm
13. Ipsilateral upper limb amputation other than a single digit (digits 2-5, partial or
full)
14. Surgical indication for shoulder treatment based on physician opinion
15. Compromised immune system (immunodeficiency or immunosuppression)
16. Current use of a Deep Brain Stimulation (DBS) system, implanted active cardiac implant
(e.g. pacemaker or defibrillator), any other implantable neuro-stimulator whose
stimulus current pathway may overlap with that of the SPRINT System
17. Patients who have a tape or adhesive allergy
18. Contraindication to Magnetic resonance imaging (metal in body, claustrophobia, body
habitus, etc) •exclude from Magnetic resonance imaging (MRI) only