Postoperative PainPhase 4NCT06709716
Impact of Preoperative Quadratus Lumborum Block on Postoperative Opioid Consumption After Laparoscopic Hysterectomy
A Phase 4 study testing Quadratus Lumborum Block (QLB), Quadratus lumborum block and Local Anesthetic Solution in people with Postoperative Pain and Laparoscopic Hysterectomy, run by Walter Reed National Military Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Pain, Laparoscopic Hysterectomy, Nerve Block
- What is being tested?
- Quadratus Lumborum Block (QLB), Quadratus lumborum block and Local Anesthetic Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to Feb 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- scheduled to undergo laparoscopic hysterectomy
- able to speak and understand English
- DEERs eligible (eligible for healthcare within military heath system)
- Owning a phone that can receive text messages or having internet access to complete questionnaires
Who cannot join
- 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)
- inability to receive liposomal or non-liposomal bupivacaine
- inability to receive non-steroidal anti-inflammatory drugs (NSAIDs)
Show all 11Show fewer
- inability to receive acetaminophen
- inability to receive oxycodone
- QL block not able to be performed bilaterally
- planned or performed mini-laparotomy (incision greater than 2cm)
- case converted to laparotomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Kathryn A Edmonds, MD, 301-400-2140, kathryn.a.edmonds2.mil@health.mil
Candice E Jones-Cox, MD, 301-319-8866, candice.e.jones-cox.civ@health.mil
About this study
Official title: Impact of Preoperative Quadratus Lumborum Block on Postoperative Opioid Consumption After Laparoscopic Hysterectomy: a Double-blinded Randomized Controlled 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?
Read more
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:
- 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.
- 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.
Read the detailed description
Context: (Background) Given the opioid epidemic, gynecologic enhanced recovery after surgery (ERAS) pathways have been developed to reduce post-operative narcotic use through multimodal pain regimens and pre-surgical anesthetic adjuncts. While local anesthetic injection at trocar incision sites has long been accepted as a standard practice to decrease postoperative pain in laparoscopic surgery, including hysterectomy, regional nerve blockades are emerging as a promising adjunct technique for management of perioperative pain. At this time, the data evaluating the effect of regional nerve blocks on postoperative pain after laparoscopic hysterectomy are limited, thus the investigators designed the following study.
Objectives: (primary and secondary objectives) To determine the impact of preoperative quadratus lumborum (QL) block on postoperative pain following laparoscopic hysterectomy. The primary outcomes will be intraoperative and immediate post-operative opioid use, measured in morphine equivalent dose (MED). Secondary outcomes will include pain scores, functional impact of pain, perception of pain and recovery, voiding dysfunction, time to discharge, nausea/vomiting, emergency room visits, readmission, and reoperation rates.
Study Design:
This study is designed as a prospective, double-blinded, randomized controlled trial comparing opioid use in women undergoing laparoscopic hysterectomy who receive a preoperative QL block to local injection of bupivacaine (common local anesthestic).
Setting/Participants:
The study will take place at a single academic medical center that is a referral center within the military health system. Eligible patients will include adult women undergoing laparoscopic hysterectomy, including robot-assisted, that are not pain management clinic patients and don't use opioids preoperatively. Patients who have contraindications to the study protocol will be ineligible. A total of 76 patients will be enrolled with 38 in each arm.
Study Interventions and Measures:
Study arm patients will receive a preoperative bilateral QL block with an admixture of liposomal bupivacaine and 0.25% bupivacaine then an intraoperative placebo injection at each incision site with 0.9% saline. Control arm patients will receive a preoperative bilateral placebo QL block with 0.9% saline then an intraoperative injection of 0.25% bupivacaine at each incision site. Pre, intra, and postoperative care will be standardized for all study patients using the Gynecologic ERAS protocol and standard hospital perioperative procedures/protocols.
Opioid use will be measured in morphine equivalent doses (MEDs) at the intraoperative and immediate postoperative (prior to discharge) timepoints, as well as, at postoperative days 1, 3, 5, 14, and 4-6 weeks. Pain scores and impact of pain on functional status will be assessed using the DVPRS and Quality of Recovery-15 survey at these timepoints.
- Being tested
- Quadratus Lumborum Block (QLB), Quadratus lumborum block, Local Anesthetic Solution
- Keywords
- postoperative pain, quadratus lumborum block, laparoscopic hysterectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadratus Lumborum Block (QLB)Drug
Also called liposomal bupivacaine
Pre-operative quadratus lumborum block with liposomal bupivacaine
Quadratus lumborum blockDrug
Also called saline
Pre-operative quadratus lumborum block with saline
Local Anesthetic SolutionDrug
Also called bupivacaine
Intraoperative injection of 0.25% bupivacaine at each incision site
Local Anesthetic SolutionDrug
Also called Saline
Intraoperative injection of saline at each incision site.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative QL block with liposomal bupivacaine, intra-operative incisional injections with placebo | Experimental | 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. Receives: Drug: Quadratus Lumborum Block (QLB); Drug: Local Anesthetic Solution |
| Preoperative QL block with placebo, intra-operative incisional injection with bupivacaine | Active comparator | 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. Receives: Drug: Quadratus lumborum block; Drug: Local Anesthetic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative opioid use
Total opioid dose, calculated in morphine equivalent dose, required during intraoperative anesthesia care
Measured: 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.
Immediate post-operative opioid use
Total opioid dose, calculated in morphine equivalent dose, required after surgery prior to discharge from the hospital
Measured: 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 (6)
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.
Measured: From discharge from the hospital to the 4-6 week post-operative appointment.
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".
Measured: 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.
Time to PACU discharge
Time from arrival to transfer out of PACU, measured in minutes
Measured: 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.
Voiding dysfunction
Inability to void post-operatively or void with inappropriately high post-void residual (urinary retention)
Measured: 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.
Pain scores after discharge
Pain scores as reported by subjects on an electronic questionnaire on post-operative days 1, 3, 5, 14 and 4-6 weeks post-operative. 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".
Measured: From discharge from the hospital to the 4-6 week post-operative appointment.
Quality of Recovery-15 scores after discharge
Quality of Recovery-15 scores reported by subjects by electronic questionnaire on post-operative days 1, 3, 5, 14 and 4-6 weeks post-operative. Quality of Recovery-15 scores range from 0 to 150 with higher scores indicating a better quality of recovery and lower scores indicating a poor quality of recovery.
Measured: From discharge from the hospital to the 4-6 week post-operative appointment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kathryn A Edmonds, MD, Principal investigator, Walter Reed National Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709716
- Sponsor's protocol ID
- WRNMMC-2024-0448
- Status last verified
- Nov 2024
- First submitted
- 15 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Edmonds K, Hunkler K, Creedon C, Drayer S, Endicott S, Eliasen K, Jones-Cox C. Impact of preoperative quadratus lumborum block on postoperative opioid consumption after laparoscopic hysterectomy: a double-blind randomized controlled trial. Pain Manag. 2025 Nov;15(11):783-790. doi: 10.1080/17581869.2025.2556648. Epub 2025 Sep 9.
PubMed 40923200
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preoperative Quadratus Lumborum Block on Postoperative Opioid Consumption After Laparoscopic Hysterectomy: a Double-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06709716
- Acronym / sponsor ID
- WRNMMC-2024-0448
- Keywords
- postoperative pain, quadratus lumborum block, laparoscopic hysterectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Detailed description
Context: (Background) Given the opioid epidemic, gynecologic enhanced recovery after surgery (ERAS) pathways have been developed to reduce post-operative narcotic use through multimodal pain regimens and pre-surgical anesthetic adjuncts. While local anesthetic injection at trocar incision sites has long been accepted as a standard practice to decrease postoperative pain in laparoscopic surgery, including hysterectomy, regional nerve blockades are emerging as a promising adjunct technique for management of perioperative pain. At this time, the data evaluating the effect of regional nerve blocks on postoperative pain after laparoscopic hysterectomy are limited, thus the investigators designed the following study.
Objectives: (primary and secondary objectives) To determine the impact of preoperative quadratus lumborum (QL) block on postoperative pain following laparoscopic hysterectomy. The primary outcomes will be intraoperative and immediate post-operative opioid use, measured in morphine equivalent dose (MED). Secondary outcomes will include pain scores, functional impact of pain, perception of pain and recovery, voiding dysfunction, time to discharge, nausea/vomiting, emergency room visits, readmission, and reoperation rates.
Study Design:
This study is designed as a prospective, double-blinded, randomized controlled trial comparing opioid use in women undergoing laparoscopic hysterectomy who receive a preoperative QL block to local injection of bupivacaine (common local anesthestic).
Setting/Participants:
The study will take place at a single academic medical center that is a referral center within the military health system. Eligible patients will include adult women undergoing laparoscopic hysterectomy, including robot-assisted, that are not pain management clinic patients and don't use opioids preoperatively. Patients who have contraindications to the study protocol will be ineligible. A total of 76 patients will be enrolled with 38 in each arm.
Study Interventions and Measures:
Study arm patients will receive a preoperative bilateral QL block with an admixture of liposomal bupivacaine and 0.25% bupivacaine then an intraoperative placebo injection at each incision site with 0.9% saline. Control arm patients will receive a preoperative bilateral placebo QL block with 0.9% saline then an intraoperative injection of 0.25% bupivacaine at each incision site. Pre, intra, and postoperative care will be standardized for all study patients using the Gynecologic ERAS protocol and standard hospital perioperative procedures/protocols.
Opioid use will be measured in morphine equivalent doses (MEDs) at the intraoperative and immediate postoperative (prior to discharge) timepoints, as well as, at postoperative days 1, 3, 5, 14, and 4-6 weeks. Pain scores and impact of pain on functional status will be assessed using the DVPRS and Quality of Recovery-15 survey at these timepoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative QL block with liposomal bupivacaine, intra-operative incisional injections with placebo | Experimental | Drug: Quadratus Lumborum Block (QLB), Drug: Local Anesthetic SolutionSubjects 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. |
| Preoperative QL block with placebo, intra-operative incisional injection with bupivacaine | Active comparator | Drug: Quadratus lumborum block, Drug: Local Anesthetic SolutionSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older
- scheduled to undergo laparoscopic hysterectomy
- able to speak and understand English
- DEERs eligible (eligible for healthcare within military heath system)
- Owning a phone that can receive text messages or having internet access to complete questionnaires
Key exclusion criteria (11 listed)
- 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)
- inability to receive liposomal or non-liposomal bupivacaine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadratus Lumborum Block (QLB)Also: liposomal bupivacainePre-operative quadratus lumborum block with liposomal bupivacaine | Drug | Preoperative QL block with liposomal bupivacaine, intra-operative incisional injections with placebo |
| Quadratus lumborum blockAlso: salinePre-operative quadratus lumborum block with saline | Drug | Preoperative QL block with placebo, intra-operative incisional injection with bupivacaine |
| Local Anesthetic SolutionAlso: bupivacaineIntraoperative injection of 0.25% bupivacaine at each incision site | Drug | Preoperative QL block with placebo, intra-operative incisional injection with bupivacaine |
| Local Anesthetic SolutionAlso: SalineIntraoperative injection of saline at each incision site. | Drug | Preoperative QL block with liposomal bupivacaine, intra-operative incisional injections with placebo |
Primary outcome
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.
Total opioid dose, calculated in morphine equivalent dose, required during intraoperative anesthesia care
Immediate post-operative opioid use
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.
Total opioid dose, calculated in morphine equivalent dose, required after surgery prior to discharge from the hospital
6 secondary outcomes
Opioid use after discharge
Time frame: From discharge from the hospital to the 4-6 week post-operative appointment.
Pain scores during inpatient post-operative care
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.
Time to PACU discharge
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.
Voiding dysfunction
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.
Pain scores after discharge
Time frame: From discharge from the hospital to the 4-6 week post-operative appointment.
Quality of Recovery-15 scores after discharge
Time frame: From discharge from the hospital to the 4-6 week post-operative appointment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Derived from this study: PubMed 40923200Edmonds K, Hunkler K, Creedon C, Drayer S, Endicott S, Eliasen K, Jones-Cox C. Impact of preoperative quadratus lumborum block on postoperative opioid consumption after laparoscopic hysterectomy: a double-blind randomized controlled trial. Pain Manag. 2025 Nov;15(11):783-790. doi: 10.1080/17581869.2025.2556648. Epub 2025 Sep 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kathryn A Edmonds, MD principal investigator
Walter Reed National Military Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quadratus Lumborum Block (QLB), Quadratus lumborum block and Local Anesthetic Solution in people with Postoperative Pain and Laparoscopic Hysterectomy, run by Walter Reed National Military Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathryn A Edmonds, MD (301-319-8866, kathryn.a.edmonds2.mil@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06709716, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.