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

NCT03490357 | Completed DMC

• 1 other identifier: Pro00075597
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Dermatomal Mapping

  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

Study Arms (2)

Control - Transversus Abdominus Plane Block

ACTIVE COMPARATOR

Standardized ERAS regional nerve block

Procedure: Control - Transversus Abdominus Plane Block

Quadratus Lumborum Block

EXPERIMENTAL

Quadratus lumborum nerve block

Procedure: Quadratus Lumborum Block

Interventions

Control - Transversus Abdominus Plane Block PROCEDURE

Abdominal fascial plane block - regional anesthesia

Control - Transversus Abdominus Plane Block

Quadratus Lumborum Block PROCEDURE

Abdominal fascial plane block - regional anesthesia

Quadratus Lumborum Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

The Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• George RM, McSwain JR, Gukasov M, Wilson DA, Nitchie H, Wilson SH. Dermatomal spread in lateral quadratus lumborum blocks versus transversus abdominus plane blocks after laparoscopic colorectal surgery: a randomized clinical trial. Reg Anesth Pain Med. 2024 Nov 7:rapm-2024-105488. doi: 10.1136/rapm-2024-105488. Online ahead of print.

  PMID: 39510803 DERIVED

Study Officials

• Renuka M George, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcome assessor and patient blinded to type of block that the patient receives. Outcome assessor will check dermatomal levels after surgery.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 30, 2018
• First Posted: April 6, 2018
• Study Start: May 15, 2018
• Primary Completion: July 11, 2023
• Study Completion: July 12, 2023
• Last Updated: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)