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

ConditionsPostoperative PainLaparoscopic HysterectomyNerve BlockQuadratus Lumborum Block
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWalter Reed National Military Medical Center

About 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 does not accept healthy volunteers

Qualifiers

18 years or older

scheduled to undergo laparoscopic hysterectomy

able to speak and understand English

DEERs eligible (eligible for healthcare within military heath system)

Disqualifiers

pre-operative opioid use

pre-operative pain management clinic patient

planned concomitant prolapse or incontinence procedure

planned concomitant non-gynecologic abdominal procedure (i.e. hernia repair)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: Preoperative QL block with liposomal bupivacaine, intra-operative incisional injections with placeboExperimental treatment 2 interventions
Group B: Preoperative QL block with placebo, intra-operative incisional injection with bupivacaineActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Intraoperative opioid use

Total opioid dose, calculated in morphine equivalent dose, required during intraoperative anesthesia care

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.
2

Immediate post-operative opioid use

Total opioid dose, calculated in morphine equivalent dose, required after surgery prior to discharge from the hospital

Time frame
From time of arrival in the PACU to time of discharge from the hospital. Anticipated to be the same day, about 4-6 hours post-operative. Will be assessed up to 24 hours after surgery if the patient remains admitted.

Secondary outcomes

1

Opioid use after discharge

Total opioid dose used, measured in morphine equivalent dose, from discharge to the following time points: post-operative day 1, 3, 5, 14 and 4-6 weeks post-operative.

Time frame
From discharge from the hospital to the 4-6 week post-operative appointment.
2

Pain scores during inpatient post-operative care

Pain scores reported by subject in the post-operative recovery areas measured by the Defense and Veterans Pain Rating Scale (DVPRS) which ranges from 0 to 10 with 0 indicating no pain and 10 indicating pain "as bad as it can be".

Time frame
From time of arrival in the PACU to time of discharge from the hospital. Anticipated to be the same day, about 4-6 hours post-operative. Will be assessed up to 24 hours after surgery if the patient remains admitted.
3

Time to PACU discharge

Time from arrival to transfer out of PACU, measured in minutes

Time frame
From time of arrival in the PACU to time of transfer to the second phase of post-operative care. Anticipated to be about 1-3 hours post-operative. Will be assessed up to 12 hours after surgery if the patient remains in the PACU.
4

Voiding dysfunction

Inability to void post-operatively or void with inappropriately high post-void residual (urinary retention)

Time frame
From time of arrival in the PACU to time of discharge from the hospital. Anticipated to be the same day, about 4-6 hours post-operative. Will be assessed up to 24 hours after surgery if the patient remains admitted.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Walter Reed National Military Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: