QL Block for Postoperative Pain in Fibroid Surgery

Overseen by Joseph Findley, MD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Joseph Findley MD

Must not be taking: Opioids

Disqualifiers: Anxiety, Depression, Coagulopathies, others

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you use chronic opioids, you may not be eligible to participate.

What data supports the effectiveness of the treatment QL Block for postoperative pain in fibroid surgery?

Research shows that the QL Block, used for pain relief after abdominal surgeries like laparoscopic hysterectomy, can reduce the need for opioids and lower pain scores. This suggests it might also help with pain after fibroid surgery. ^{1 2 3 4 5}

Is the quadratus lumborum block safe for humans?

The quadratus lumborum (QL) block has been used safely for managing pain after various surgeries, including abdominal, gynecological, and orthopedic procedures. It is generally considered safe, with studies showing reduced pain and opioid use, but more research is needed to confirm the best techniques. ^{1 2 6 7 8}

How does the QL block treatment differ from other treatments for postoperative pain in fibroid surgery?

The QL block treatment is unique because it uses an ultrasound-guided technique to deliver local anesthesia to a specific area in the lower back, providing targeted pain relief after surgery. This method can reduce the need for opioids and improve patient satisfaction compared to traditional pain management options. ^{1 2 4 6 8}

Research Team

Joseph Findley, MD

Principal Investigator

University Hospitals

Eligibility Criteria

This trial is for individuals needing surgery to remove uterine fibroids who can follow the study's procedures and are available throughout the study. They must understand and sign a consent form. It excludes those with anxiety, depression, blood clotting issues, chronic pain or opioid use, non-English speakers, and those with a BMI over 38.

Inclusion Criteria

I am willing and able to follow all study rules and be available for its duration.

I need surgery for uterine fibroids but want to keep my uterus.

Provision of signed and dated informed consent form

Exclusion Criteria

I have been diagnosed with anxiety or depression.

I have a blood clotting disorder.

Illiteracy due to inability to read and understand plain questionnaire

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a myomectomy procedure with or without a QL block for postoperative pain management

1 week

1 visit (in-person)

Follow-up

Participants are monitored for pain levels and satisfaction with pain management up to 48 hours after discharge

1 week

1 visit (virtual)

Treatment Details

Interventions

• QL Block (Procedure)

Trial Overview The trial tests if a QL block—an anesthetic injection in the lower back—reduces post-surgery pain after myomectomy (fibroid removal). Participants will either receive this block along with standard care or just standard care alone. Assignment to these groups is random.

Participant Groups

Group I: QL Block with Bupivacaine Experimental Treatment 1 Intervention

Participants will get a QL block using 30cc Bupivacaine bilaterally in quadratus lumborum muscle (60cc total).

Group II: Control Placebo Group 1 Intervention

Participants will get a sham injection of 30cc saline bilaterally in quadratus lumborum muscle (60cc total).

Who Is Running the Clinical Trial?

Joseph Findley MD

Lead Sponsor

Trials

1

Recruited

80+

Findings from Research

The quadratus lumborum (QL) block is an effective postoperative analgesic technique for major laparotomy, resulting in low pain scores and reduced opioid consumption on the first day after surgery.

This method provides sensory block up to the T8-L1 levels, indicating its potential for effective pain management in abdominal surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. Kadam, VR.[2022]

In a study involving 36 women undergoing elective cesarean sections, the intramuscular quadratus lumborum block (QLBi) did not significantly extend the time to first postoperative analgesic use compared to a placebo, indicating limited effectiveness for pain relief.

The results suggest that the specific concentration and volume of ropivacaine used in the QLBi may not provide substantial benefits for postoperative analgesia after cesarean sections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of the intramuscular quadratus lumborum block in postoperative analgesia after cesarean section with vertical incision: a randomized, double-blinded placebo-controlled study. Yoshida, K., Tanaka, S., Watanabe, K., et al.[2022]

The Quadratus lumborum (QL) block significantly reduces opioid requirements in patients undergoing cesarean deliveries and renal surgeries, based on a systematic review of 22 studies.

QL block may provide effective postoperative analgesia for up to 24 hours, although evidence for its effectiveness in other types of surgeries is limited and further studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single injection Quadratus Lumborum block for postoperative analgesia in adult surgical population: A systematic review and meta-analysis. Jin, Z., Liu, J., Li, R., et al.[2021]

In a study of 60 female patients undergoing total abdominal hysterectomy, bilateral quadratus lumborum (QL) block resulted in significantly lower consumption of opioids (fentanyl and morphine) compared to bilateral transverse abdominis plane (TAP) block.

Patients receiving the QL block reported lower pain scores at all postoperative time points and experienced a longer duration of analgesia, indicating that QL block is more effective for pain management after this type of surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quadratus Lumborum Block versus Transversus Abdominis Plane Block in Patients Undergoing Total Abdominal Hysterectomy: A Randomized Prospective Controlled Trial. Yousef, NK.[2022]

In a study of 60 patients undergoing lumbar disc herniation surgery, the quadratus lumborum block (QLB) significantly reduced postoperative pain scores at 0 and 2 hours compared to a control group, indicating its efficacy in pain management.

Patients receiving the QLB reported higher satisfaction and required less rescue analgesia, while also experiencing fewer instances of nausea, suggesting that QLB not only improves pain control but also enhances overall patient comfort after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of ultrasound-guided anterior quadratus lumborum block for pain management following lumbar spinal surgery: a randomized controlled trial. Alver, S., Bahadir, C., Tahta, AC., et al.[2022]

In a study of 80 patients undergoing total hip arthroplasty, the quadratus lumborum (QL) block significantly reduced pain scores and opioid consumption for up to 48 hours post-surgery compared to a control group without the block.

Patients receiving the QL block reported higher satisfaction scores, indicating that this technique not only provides effective pain relief but also enhances the overall patient experience after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anterior quadratus lumborum block analgesia for total hip arthroplasty: a randomized, controlled study. Kukreja, P., MacBeth, L., Sturdivant, A., et al.[2021]

Bilateral quadratus lumborum (QL) block provided significant pain relief for a 43-year-old woman after uterine artery embolization, reducing her pain score from 8/10 to 3/10 within an hour and maintaining low pain levels (2-3/10) for 24 hours without the need for additional analgesics.

The study suggests that QL block could be a highly effective alternative for managing acute postoperative pain after uterine artery embolization, potentially reducing reliance on opioids and improving patient comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quadratus lumborum block in management of severe pain after uterine artery embolization. Ben-David, B., Kaligozhin, Z., Viderman, D.[2019]

References

1. India pubmed.ncbi.nlm.nih.gov

Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Ultrasound-guided anterior and posterior quadratus lumborum block for analgesia after laparoscopic hysterectomy. [2021]

3. Japan pubmed.ncbi.nlm.nih.gov

The effectiveness of the intramuscular quadratus lumborum block in postoperative analgesia after cesarean section with vertical incision: a randomized, double-blinded placebo-controlled study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Single injection Quadratus Lumborum block for postoperative analgesia in adult surgical population: A systematic review and meta-analysis. [2021]

5. India pubmed.ncbi.nlm.nih.gov

Quadratus Lumborum Block versus Transversus Abdominis Plane Block in Patients Undergoing Total Abdominal Hysterectomy: A Randomized Prospective Controlled Trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

The efficacy of ultrasound-guided anterior quadratus lumborum block for pain management following lumbar spinal surgery: a randomized controlled trial. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Anterior quadratus lumborum block analgesia for total hip arthroplasty: a randomized, controlled study. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Quadratus lumborum block in management of severe pain after uterine artery embolization. [2019]