- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03490357
Quadratus Lumborum Versus Transversus Abdominis Plane Nerve Block: A Comparison Study
Quadratus Lumborum Versus Transversus Abdominis Plane Nerve Block: A Comparison in Regional Anesthesia Techniques With an Enhanced Recovery After Surgery Pathway
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Transversus Abdominis Plane (TAP) block is the current standard of care for patients undergoing laparoscopic abdominal surgeries with the Enhanced Recovery After Surgery (ERAS) Protocol. The Quadratus Lumborum (QL) is another established abdominal fascial plane block that is comparable in procedure and risks and may potentially be more beneficial. The study compares the two blocks in hopes of establishing a new standard of care for patients undergoing laparoscopic abdominal surgeries with the ERAS protocol.
- Compare QL and TAP blocks cephalad spread via mapping in the Postoperative Acute Care Unit (PACU) within 6 hours after block placement.
- Compare efficacy of blocks via Visual Analogue Scale (VAS) pain scores in PACU and postoperative day (POD) 1.
- Compare amount of opioid pain medications consumed within 24 hours after block. Hypothesis
- The QL block will prove superior to the TAP block in both cephalad spread and pain control for abdominal surgery patients and decrease the amount of opioid pain medications required while in effect up to 24 hours after surgery.
- The quadratus lumborum will have increased cephalad spread. We predict mapping will show greater (2 or more dermatomal levels) or equal analgesic coverage by the QL block when compared to the TAP block.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- The Medical University of South Carolina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Patients scheduled for laparoscopic abdominal surgery as posted by the surgeon
- Part of the ERAS protocol as listed by the surgeon
- Age 18 years and older
- Elective procedure
Exclusion Criteria:
• Patient inability to consent
- Patient inability to communicate for data collection
- Conversion from laparoscopic to open case
- Local anesthetic allergy
- Weight less than 50 kg
- Anatomical variation making block visualization unlikely
- Inability to cooperate with block
- Surgery posted longer than 6 hours
- Known preoperative substance abuse
- Chronic opioid use > 3 months
- Patient exhibits dependence on opioids Daily opioid use for pain control
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control - Transversus Abdominus Plane Block
Standardized ERAS regional nerve block
|
Abdominal fascial plane block - regional anesthesia
|
|
Experimental: Quadratus Lumborum Block
Quadratus lumborum nerve block
|
Abdominal fascial plane block - regional anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dermatomal Mapping
Time Frame: 6 hours
|
The primary outcome of interest is the proportion of subjects reporting a positive block.
This is determined by dermatomal mapping in cephalad direction in PACU within 6 hours of TAP or QL placement.
A positive outcome is one where the QL block measures 2 or more dermatomal levels higher than the TAP block
|
6 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Renuka M George, MD, Medical University of South Carolina
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Pro00075597
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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