Clinical trial NCT03490357: Quadratus Lumborum Versus Transversus Abdominis Plane Nerve Block: A Comparison Study
Official title: Quadratus Lumborum Versus Transversus Abdominis Plane Nerve Block: A Comparison in Regional Anesthesia Techniques With an Enhanced Recovery After Surgery Pathway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2018-04-06
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Dermatomal Mapping
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: The Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Renuka M George, MD
role: PRINCIPAL_INVESTIGATOR
References: