Postoperative PainPhase 4NCT05979493
QL Block in Laparoscopic Myomectomy
A Phase 4 study testing Bupivacain and Saline in people with Postoperative Pain and Fibroid Uterus, run by Joseph Findley MD at 1 site in United States.
Trial summary
This study aims to determine the efficacy of a quadratus lumborum (QL) block in decreasing postoperative pain in patients undergoing myomectomy for uterine fibroids. A QL block is a temporary anesthetic injection in the quadratus lumborum muscle, a muscle in the lower back, that has been previously shown to… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postoperative Pain, Fibroid Uterus
- What is being tested?
- Bupivacain and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2024to 3 Jul 2028
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Presence of uterine fibroids requiring surgical excision with preservation of the uterus
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Provision of signed and dated informed consent form
Who cannot join
- Pre-existing diagnoses of anxiety or depression
- Pre-existing coagulopathies
- Pre-existing neuropathic or chronic pelvic pain
- Chronic opioid use
- Illiteracy due to inability to read and understand plain questionnaire
- Non-English speaking
- BMI >38
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, 1 recruiting
- Recruiting
University Hospitals Ahuja Medical Center
Beachwood, Ohio, 44122
Catherine P Haering, BA, 3392011531, cph43@case.edu
About this study
Official title: Quadratus Lumborum Block to Improve Postoperative Pain Management After Laparoscopic Myomectomies: a Double-blinded and Prospective Randomized Clinical Trial.
This study aims to determine the efficacy of a quadratus lumborum (QL) block in decreasing postoperative pain in patients undergoing myomectomy for uterine fibroids. A QL block is a temporary anesthetic injection in the quadratus lumborum muscle, a muscle in the lower back, that has been previously shown to significantly reduce postoperative pain levels in patients undergoing abdominal and pelvic surgery. Because of its demonstrated effects, the QL block is becoming a standard of anesthesia and surgical care. Since participants will be undergoing a myomectomy procedure, the investigators believe that participants may qualify to participate in this study. The investigators will be comparing patients who receive the QL block (in addition to standard anesthesia and postoperative pain care) with patients who do not receive the QL block (in addition to standard care). The participants will be randomly assigned to one of the two groups and may or may not actually receive the block.
- Conditions
- Postoperative Pain, Fibroid Uterus
- Being tested
- Bupivacain, Saline
- Keywords
- QL Block, Myomectomy
- Medical subject headings
- Pain, Postoperative, Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacainDrug
30cc IM injection in each quadratus lumborum muscle (60cc total).
SalineDrug
30cc IM injection in each quadratus lumborum muscle (60cc total).
| Study group | Role | What they receive |
|---|---|---|
| QL Block with Bupivacaine | Experimental | Participants will get a QL block using 30cc Bupivacaine bilaterally in quadratus lumborum muscle (60cc total). Receives: Drug: Bupivacain |
| Control | Sham comparator | Participants will get a sham injection of 30cc saline bilaterally in quadratus lumborum muscle (60cc total). Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in minutes from first analgesic request as measured by medical chart review
Measured: Up to 24 hours
Total number of doses of rescue analgesics given as measured by medical chart review
Measured: Up to 24 hours
Secondary outcomes (2)
Pain as measured by visual analog scale (VAS)
VAS is a pain scale from 0-10 with 0 being no pain and 10 being the worst pain ever.
Measured: Up to 48 hours after discharge from hospital.
Patient satisfaction with perioperative pain management measured on a scale of 1-10
Pain management scale with 1 being very disappointed in pain management with 10 being highly satisfied with pain managment.
Measured: Up to 48 hours after discharge from hospital.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start24 Aug 2024
- Primary completion1 Jul 2028 (estimated)
- Study completion3 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joseph Findley MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joseph Findley MD, University Hospitals Cleveland Medical Center
- Investigators
- Joseph Findley, MD, Principal investigator, University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979493
- Sponsor's protocol ID
- STUDY20230830
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2023
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadratus Lumborum Block to Improve Postoperative Pain Management After Laparoscopic Myomectomies: a Double-blinded and Prospective Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05979493
- Acronym / sponsor ID
- STUDY20230830
- Conditions
- Postoperative Pain, Fibroid Uterus
- Keywords
- QL Block, Myomectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Joseph Findley MDUniversity, hospital or other
- Study start
- 24 Aug 2024 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 3 Jul 2028 (estimated)
- First posted
- 7 Aug 2023 (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.
This study aims to determine the efficacy of a quadratus lumborum (QL) block in decreasing postoperative pain in patients undergoing myomectomy for uterine fibroids. A QL block is a temporary anesthetic injection in the quadratus lumborum muscle, a muscle in the lower back, that has been previously shown to significantly reduce postoperative pain levels in patients undergoing abdominal and pelvic surgery. Because of its demonstrated effects, the QL block is becoming a standard of anesthesia and surgical care. Since participants will be undergoing a myomectomy procedure, the investigators believe that participants may qualify to participate in this study. The investigators will be comparing patients who receive the QL block (in addition to standard anesthesia and postoperative pain care) with patients who do not receive the QL block (in addition to standard care). The participants will be randomly assigned to one of the two groups and may or may not actually receive the block.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QL Block with Bupivacaine | Experimental | Drug: BupivacainParticipants will get a QL block using 30cc Bupivacaine bilaterally in quadratus lumborum muscle (60cc total). |
| Control | Sham comparator | Drug: SalineParticipants will get a sham injection of 30cc saline bilaterally in quadratus lumborum muscle (60cc total). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Presence of uterine fibroids requiring surgical excision with preservation of the uterus
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Provision of signed and dated informed consent form
Key exclusion criteria (7 listed)
- Pre-existing diagnoses of anxiety or depression
- Pre-existing coagulopathies
- Pre-existing neuropathic or chronic pelvic pain
- Chronic opioid use
- Illiteracy due to inability to read and understand plain questionnaire
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 |
|---|---|---|
| Bupivacain30cc IM injection in each quadratus lumborum muscle (60cc total). | Drug | QL Block with Bupivacaine |
| Saline30cc IM injection in each quadratus lumborum muscle (60cc total). | Drug | Control |
Primary outcome
Time in minutes from first analgesic request as measured by medical chart review
Time frame: Up to 24 hours
Total number of doses of rescue analgesics given as measured by medical chart review
Time frame: Up to 24 hours
2 secondary outcomes
Pain as measured by visual analog scale (VAS)
Time frame: Up to 48 hours after discharge from hospital.
Patient satisfaction with perioperative pain management measured on a scale of 1-10
Time frame: Up to 48 hours after discharge from hospital.
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 11 Sep 2026.
- 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.
Joseph Findley, MD principal investigator
University Hospitals
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 Bupivacain and Saline in people with Postoperative Pain and Fibroid Uterus, run by Joseph Findley MD 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. 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. Some participants in this study may receive a placebo. 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 Catherine P Haering, BA (3392011531, cph43@case.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in minutes from first analgesic request as measured by medical chart review (time frame: Up to 24 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?
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 11 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.