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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Walter Reed National Military Medical Center
Study ID
NCT06709716
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Quadratus Lumborum Block (QLB) — DRUG
    Pre-operative quadratus lumborum block with liposomal bupivacaine
  • Quadratus lumborum block — DRUG
    Pre-operative quadratus lumborum block with saline
  • Local Anesthetic Solution — DRUG
    Intraoperative injection of 0.25% bupivacaine at each incision site
  • Local Anesthetic Solution — DRUG
    Intraoperative injection of saline at each incision site.

Study Details

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.

Key Dates

Start date
Dec 1, 2024
Status verified
Nov 2024
Primary completion
Dec 31, 2025
Completion
Feb 28, 2026

Study Design

Enrollment
76 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Preoperative QL block with liposomal bupivacaine, intra-operative incisional injections with placebo
    Subjects will receive a pre-operative quadratus lumborum nerve block with liposomal bupivacaine and then an intra-operative placebo injection at each incision site with saline.
  • Active Comparator: Preoperative QL block with placebo, intra-operative incisional injection with bupivacaine
    Subjects will undergo a sham pre-operative quadratus lumborum block procedure with saline and then an intra-operative injection of local anesthetic (0.25% bupivacaine) at each incision site.

Primary Outcome Measure

Intraoperative opioid use [ Time Frame: From anesthesia induction to the time the patient leaves the operating room, this is considered the "in-room time". Anticipated to be between 2-6 hours. Will be assessed up to 12 hours. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Walter Reed National Military Medical CenterBethesdaMaryland20889
Kathryn A Edmonds, MD
[email protected]
301-400-2140
Candice E Jones-Cox, MD
[email protected]
301-319-8866
Kathryn A Edmonds, MD

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