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
studyfinder@utsouthwestern.edu
Enas Kandil
74036
All
18 Years to 80 Years old
Phase 4
NCT03115151
STU 092016-061
Drug: Bupivacaine, Drug: Hydromorphone, Drug: Fentanyl
Pain
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
studyfinder@utsouthwestern.edu
Anthony Machi
159003
All
18 Years and over
N/A
NCT03816982
STU 082018-017
Procedure: Single-injection bupivacaine HCl plus liposomal bupivacaine, Procedure: Single-injection bupivacaine HCl plus a subsequent bupivacaine CISB
Shoulder Pain
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
studyfinder@utsouthwestern.edu
Peter Szmuk
80418
All
up to 2 Years old
Phase 3
NCT03089905
STU 052017-065
Drug: Sevoflurane, Drug: Remifentanil, Drug: Dexmedetomidine
Neurotoxicity, Anesthesia, Child Development
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.
Call 214-648-5005
studyfinder@utsouthwestern.edu
studyfinder@utsouthwestern.edu
John Alexander
52265
Female
18 Years to 80 Years old
N/A
NCT04074226
STU-2019-1174
Procedure: Erector Spinae Plane block, Procedure: Quadratus Lumborum Block
Postoperative Pain
regional anesthesia, postoperative pain, erector spinae plane block, quadratus lumborum block