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Quadratus Lumborum Versus Transversus Abdominis Plane Nerve Block: A Comparison Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03490357
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anesthesia Procedure: Control - Transversus Abdominus Plane Block Procedure: Quadratus Lumborum Block Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The expected cephalad dermatomal distribution of the TAP block is T10. A positive outcome is a QL block with patient anesthesia at 2 or more dermatomes higher than the TAP block. The investigators will assume that there is a 30% difference between the two blocks, which leads to between 24 and 33 patients in each arm (ideally aiming for 30 patients in each group).

The investigators have included other sample sizes should they find that there is a higher or lower percentage difference between the QL and TAP blocks.

Outcome: A positive block is considered anesthesia at T8 or above and a negative block is considered analgesia below T8

Masking: Double (Participant, Outcomes Assessor)
Masking Description: Outcome assessor and patient blinded to type of block that the patient receives. Outcome assessor will check dermatomal levels after surgery.
Primary Purpose: Treatment
Official Title: Quadratus Lumborum Versus Transversus Abdominis Plane Nerve Block: A Comparison in Regional Anesthesia Techniques With an Enhanced Recovery After Surgery Pathway
Actual Study Start Date : May 15, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Active Comparator: Control - Transversus Abdominus Plane Block
Standardized ERAS regional nerve block
Procedure: Control - Transversus Abdominus Plane Block
Abdominal fascial plane block - regional anesthesia

Experimental: Quadratus Lumborum Block
Quadratus lumborum nerve block
Procedure: Quadratus Lumborum Block
Abdominal fascial plane block - regional anesthesia




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490357


Contacts
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Contact: Renuka George, MD 843-792-1869 georgere@musc.edu

Locations
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United States, South Carolina
The Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Renuka George, MD    843-792-1869    georgere@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Renuka M George, MD Medical University of South Carolina

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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03490357    
Other Study ID Numbers: Pro00075597
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs