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Impact of Preoperative Quadratus Lumborum Block on Postoperative Opioid Consumption After Laparoscopic Hysterectomy

NCT06709716 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2024-11-29

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if preoperative nerve block (quadratus lumborum \[QL\] block) works to improve pain control during and after laparoscopic hysterectomy. The main questions it aims to answer are:

Does QL block decrease the amount of narcotic medication needed during surgery? Does QL block decrease the amount of narcotic medication needed after surgery?

Researchers will compare QL block to local injection of a numbing medication at each incision site (the current standard practice) to see if QL block works to decrease surgical pain.

Participants will be randomly assigned to receive one of the two following interventions:

1. QL block before surgery with a long-acting numbing medicine (liposomal bupivacaine) and then injection of placebo (saline) at each incision site in the operating room.
2. QL block before surgery with placebo (saline) and then injection of local numbing medicine (bupivacaine) at each incision site in the operating room.

Participants will also:

* Visit the clinic/hospital for a pre-operative appointment, the surgical procedure, and a 4-6 week post-operative appointment (all standard visits even if not participating in research)
* Complete a questionnaire electronically, or by phone, that takes \<10 minutes at the pre-operative appointment and on postoperative days 1, 3, 5, 14, and 4-6 weeks.

Conditions

  • Postoperative Pain
  • Laparoscopic Hysterectomy
  • Nerve Block
  • Quadratus Lumborum Block

Interventions

DRUG

Quadratus Lumborum Block (QLB)

Pre-operative quadratus lumborum block with liposomal bupivacaine

DRUG

Quadratus lumborum block

Pre-operative quadratus lumborum block with saline

DRUG

Local Anesthetic Solution

Intraoperative injection of 0.25% bupivacaine at each incision site

DRUG

Local Anesthetic Solution

Intraoperative injection of saline at each incision site.

Sponsors & Collaborators

  • Walter Reed National Military Medical Center

    lead FED

Principal Investigators

  • Kathryn A Edmonds, MD · Walter Reed National Military Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-12-31
Completion
2026-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06709716 on ClinicalTrials.gov