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

Anesthesia Clinical Trial

Official title:

Quadratus Lumborum Versus Transversus Abdominis Plane Nerve Block: A Comparison in Regional Anesthesia Techniques With an Enhanced Recovery After Surgery Pathway

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03490357
• Other study ID #: Pro00075597
• Status: Completed
• Phase: N/A
• Start date: May 15, 2018
• Est. completion date: July 12, 2023

Study information

• Verified date: August 2023
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: July 12, 2023
• Est. primary completion date: July 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Procedure:
• Control - Transversus Abdominus Plane Block
Abdominal fascial plane block - regional anesthesia
• Quadratus Lumborum Block
Abdominal fascial plane block - regional anesthesia

Locations

Country	Name	City	State
United States	The Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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