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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.
18 Years and over
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
Drug: Ropivacaine 0.35%
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.
18 Years to 80 Years old
• Adult subjects aged 18 years or older
• Scheduled for elective posterior lumbar spinal fusion surgery between 1 and 3 levels
• Baseline cognitive deficits sufficient to make objective pain self-assessments unreliable in the estimation of the Study Investigators.
• Immunocompromised subject
• 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.
• 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
Drug: Bupivacaine, Drug: Hydromorphone, Drug: Fentanyl
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.
18 Years and over
Phase 2/Phase 3
• 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)
• central lung
• abdominal-pelvic(lymph node/adrenal gland)
• 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
• 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
Radiation: Stereotactic Radiosurgery, Procedure: Therapeutic Conventional Surgery, Other: Laboratory Biomarker Analysis
Fatigue, Stage IV Breast Cancer, Pain, Nausea and Vomiting, Dyspnea, Breast - Female
UT Southwestern; Children’s Health
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.
18 Years to 75 Years old
• 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
• 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).
18 Years and over
• 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.
• 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
• 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.
up to 2 Years old
• 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.
• 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
Drug: Sevoflurane, Drug: Remifentanil, Drug: Dexmedetomidine
Neurotoxicity, Anesthesia, Child Development
Parkland Health & Hospital System
ESP vs QL for Total Abdominal Hysterectomy
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.
18 Years to 80 Years old
• 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
• 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
Procedure: Erector Spinae Plane block, Procedure: Quadratus Lumborum Block
regional anesthesia, postoperative pain, erector spinae plane block, quadratus lumborum block
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.
18 Years and over
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
Other: Lavender-Sandalwood scented aromatherapy sticker
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).
21 Years to 100 Years old
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
Device: Contracting Producing Peripheral Nerve Stimulation, Device: Non Contracting Producing Peripheral Nerve Stimulation, Other: Physical Therapy
Shoulder Pain, Shoulder Impingement Syndrome, Shoulder Tendinitis, Shoulder Bursitis, Pain, Shoulder
peripheral nerve stimulation, Sprint, stimulation