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Completed

NCT Number: NCT03490357

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control - Transversus Abdominus Plane Block

Procedure

Abdominal fascial plane block - regional anesthesia

quadratus lumborum block

Procedure

Abdominal fascial plane block - regional anesthesia

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Apr 6, 2018
Registry last updated
Aug 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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