Quadratus Lumborum Block for Postoperative Pain

Recruiting in Palo Alto (17 mi)

Overseen ByKathryn A Edmonds, MD

Age: 18+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Walter Reed National Military Medical Center

No Placebo Group

Prior Safety Data

Approved in 1 jurisdiction

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals scheduled for laparoscopic hysterectomy who are interested in better pain control. Participants must attend standard pre-operative and post-operative appointments, as well as complete short questionnaires on their pain levels at specified times after surgery.

Inclusion Criteria

I am 18 years old or older.

I am scheduled for a laparoscopic hysterectomy.

Exclusion Criteria

I cannot take oxycodone.

My surgery was changed to an open procedure.

I cannot have a QL block done on both sides of my body.

I have used opioids before surgery.

I am scheduled for a non-gynecologic abdominal procedure, like hernia repair.

I cannot take NSAIDs.

I am scheduled for surgery to fix prolapse or incontinence.

I cannot receive certain pain medications.

I am scheduled for or have had a surgery with an incision larger than 2cm.

Participant Groups

The study tests if a QL block with liposomal bupivacaine before surgery reduces the need for narcotic medication during and after the procedure compared to just local numbing at incision sites. Patients will be randomly assigned to receive either the QL block or placebo plus local anesthetic.

2Treatment groups

Experimental Treatment

Active Control

Group I: Preoperative QL block with liposomal bupivacaine, intra-operative incisional injections with placeboExperimental Treatment2 Interventions

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.

Group II: Preoperative QL block with placebo, intra-operative incisional injection with bupivacaineActive Control2 Interventions

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.