Bupivacaine for Endometriosis

Overseen By Ann Tims

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Baylor College of Medicine

Disqualifiers: Prisoners, Pregnant, Mental disabilities, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: Day of surgery

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find better pain relief methods for individuals undergoing surgery for endometriosis, a condition causing significant pelvic pain. Researchers seek to determine if injecting a numbing medicine called bupivacaine (also known as Marcaine or Exparel) near specific nerves can reduce pain and the need for opioids after surgery. Participants will receive either this numbing medicine or a placebo (a harmless substance with no effect) and will report their pain levels and opioid usage for a week. The trial seeks individuals scheduled for robotic surgery to remove endometriosis. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, helping researchers understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for the superior hypogastric nerve plexus block with bupivacaine?

Research has shown that bupivacaine, when used in a nerve block, is generally well-tolerated and can effectively reduce pain. Studies have found that a superior hypogastric nerve block with bupivacaine can significantly lower pain levels in patients undergoing gynecologic surgeries. Although this method has not been fully studied in endometriosis surgeries, it has shown promise in similar situations.

Importantly, the FDA has already approved bupivacaine for use as a local anesthetic, confirming its safety. Common side effects might include mild numbness or tingling, but serious side effects are rare when administered at the correct dose by a trained professional. Overall, existing research supports the safety of this treatment for managing pain in humans. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike most treatments for endometriosis, which often involve hormonal therapies or surgery, the investigational use of Bupivacaine targets pain directly. Researchers are excited about this approach because Bupivacaine is administered as a nerve block, specifically targeting the superior hypogastric nerve plexus, which is a novel method for alleviating pain associated with endometriosis. This direct delivery could mean faster and more localized pain relief without the systemic side effects that come with hormonal treatments.

What evidence suggests that a superior hypogastric nerve plexus block with bupivacaine is effective for reducing postoperative pain in endometriosis?

Research shows that bupivacaine can help reduce pelvic pain caused by endometriosis. In this trial, participants in the investigative treatment arm will receive a diluted form of bupivacaine injected into the superficial retroperitoneal area over the superior hypogastric nerve plexus during surgery. Previous studies have shown that a specific type of nerve block with bupivacaine significantly reduced chronic pelvic pain in patients with difficult-to-treat endometriosis. Another study found that using a diluted form of bupivacaine helped manage pain related to endometriosis for at least three months. These findings suggest that bupivacaine might help reduce pain and possibly decrease the need for opioids after surgery in women with endometriosis. ^{5 6 7 8 9}

Who Is on the Research Team?

Xiaoming Guan, PhD, MD

Principal Investigator

Department Chair of Minimally Invasive Gynecologic Surgery

Are You a Good Fit for This Trial?

This trial is for women of reproductive age who are undergoing robotic surgery to remove endometriosis. Participants must be able to rate their pain and keep track of any opioid painkillers they use after the operation.

Inclusion Criteria

I am scheduled for a robotic surgery to remove endometriosis.

Exclusion Criteria

Subjects who are prisoners

Pregnant individuals

Individuals with mental disabilities or cognitive impairment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-4 weeks

1 visit (in-person)

Treatment

Participants undergo robotic assisted resection of endometriosis with either a superior hypogastric nerve plexus block using 0.25% bupivacaine hydrochloride or a placebo saline injection

Day of surgery

1 visit (in-person)

Postoperative Monitoring

Participants' postoperative pain levels are monitored using the Visual Analog Scale (VAS) at 0, 2, and 4 hours after surgery, and daily for 7 days

1 week

Daily self-reported

Follow-up

Participants are monitored for safety and effectiveness after treatment, including opioid use documentation

1 week

1 follow-up call

What Are the Treatments Tested in This Trial?

Interventions

• Superior Hypogastric Nerve Plexus Block with Bupivacaine

Trial Overview The study tests if injecting Bupivacaine, a numbing medication, near nerves affected by endometriosis surgery can reduce pain and need for opioids post-surgery compared to using saline, a placebo. Pain levels will be tracked for one week.

How Is the Trial Designed?

Group I: Investigative Treatment Experimental Treatment 1 Intervention

During the surgery, the investigative treatment group will have 5cc of diluted 0.25% Bupivacaine Hydrochloride injected into the superficial retroperitoneal area over the superior hypogastric nerve plexus.

Group II: Placebo Placebo Group 1 Intervention

During the surgery, the placebo group will have 5cc of 0.9% normal saline injected into the superficial retroperitoneal area over the superior hypogastric nerve plexus.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Published Research Related to This Trial

In a study involving 98 mice, liposomal bupivacaine (Exparel®) provided a longer duration of pain relief compared to standard bupivacaine, with motor block lasting up to 180 minutes and thermoalgesic block lasting up to 420 minutes.

The addition of dexamethasone, either perineurally or systemically, significantly reduced neural inflammation caused by bupivacaine, and perineural dexamethasone also helped reduce inflammation from Exparel®, suggesting a protective effect against nerve damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perineural dexamethasone attenuates liposomal bupivacaine-induced delayed neural inflammation in mice in vivo. Ferré, F., Krin, A., Sanchez, M., et al.[2020]

In a study of 50 patients undergoing minimally invasive gynecologic surgery, a superior hypogastric plexus nerve block significantly reduced opioid use by 38% in the first 24 hours post-surgery, with an average of 33.1 MME compared to 54.9 MME in the control group.

The nerve block also resulted in lower pain scores (1.8 vs. 2.6 on a visual analog scale), and no adverse effects were reported, indicating it is a safe and effective method for pain management after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Superior Hypogastric Plexus Nerve Block in Minimally Invasive Gynecology: A Randomized Controlled Trial. De Silva, P., Daniels, S., Bukhari, ME., et al.[2022]

In a multicenter trial involving 100 women undergoing laparoscopic hysterectomy, the use of a superior hypogastric plexus block did not significantly reduce postoperative pain compared to those who did not receive the block, with 57% of the block group and 43% of the control group reporting a mean pain score lower than 4 within 2 hours post-surgery.

The study suggests that, despite the potential benefits of nerve blocks in pain management, the superior hypogastric plexus block did not provide a significant advantage in pain relief in this specific surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Superior Hypogastric Plexus Block to Reduce Pain After Laparoscopic Hysterectomy: A Randomized Controlled Trial. Clark, NV., Moore, K., Maghsoudlou, P., et al.[2023]

In a study of 16 patients with refractory endometriosis, the superior hypogastric plexus (SHP) block significantly reduced chronic pelvic pain and improved quality of life, with positive effects lasting up to 24 weeks.

No serious adverse effects were reported, indicating that SHP block is a safe and effective option for pain management in patients suffering from refractory endometriosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Superior hypogastric plexus block as an effective treatment method for endometriosis-related chronic pelvic pain: an open-label pilot clinical trial. Khodaverdi, S., Alebouyeh, MR., Sadegi, K., et al.[2021]

In a study of 68 women undergoing total abdominal hysterectomy, the use of a superior hypogastric plexus block with ropivacaine significantly reduced postoperative opioid consumption compared to a placebo, with median consumption of 55.8 mg versus 72.4 mg (P = 0.032).

Patients receiving the ropivacaine block reported better pain control, with 63% scoring their pain as less than 4 on the VAS scale at 2 hours post-surgery, compared to only 25% in the placebo group (P = 0.015), and no significant side effects were observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Superior hypogastric plexus block as a new method of pain relief after abdominal hysterectomy: double-blind, randomised clinical trial of efficacy. Rapp, H., Ledin Eriksson, S., Smith, P.[2022]

In a study of 20 patients undergoing lingual nerve microsurgery, those who received liposomal bupivacaine (LB) reported significantly less postoperative pain and consumed fewer opioid pills compared to those who received bupivacaine hydrochloride (BH).

The findings suggest that LB, with its prolonged duration of action, is more effective in reducing postoperative pain and opioid consumption, supporting its use in surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liposomal bupivacaine use in exploratory lingual nerve microsurgery: does liposomal bupivacaine use decrease postoperative pain and opioid consumption compared to bupivacaine hydrochloride? A pilot study. Jacobus, D., Mehr, S., Ziccardi, V.[2021]

In a study involving five women with endometriosis and chronic pelvic pain, CT-guided superior hypogastric plexus block provided varying degrees of pain relief, with one patient experiencing complete pain relief.

The procedure was generally safe, with only one instance of mild pain relief and no significant complications, indicating its potential as a viable option for managing chronic pelvic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Superior hypogastric plexus block for chronic pelvic pain in the presence of endometriosis: CT techniques and results. Wechsler, RJ., Maurer, PM., Halpern, EJ., et al.[2004]

In a pilot study involving 25 pigs, subarachnoid administration of liposomal bupivacaine resulted in a longer duration of pain relief compared to standard bupivacaine hydrochloride, with effects lasting up to 32 hours for higher doses.

No signs of neurotoxicity were observed in any treatment group, suggesting that liposomal bupivacaine may be a safe option for extended analgesia in the neuraxial space, warranting further studies for potential human use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurological and histological outcomes after subarachnoid injection of a liposomal bupivacaine suspension in pigs: a pilot study. Zel, J., Hadzic, A., Cvetko, E., et al.[2019]

Citations

1. withpower.com withpower.com/trial/phase-4-endometriosis-7-2024-9794a

Bupivacaine for Endometriosis In a study of 16 patients with refractory endometriosis, the superior hypogastric plexus (SHP) block significantly reduced chronic pelvic pain and improved ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26070226/

A randomized, placebo-controlled, double-blind study of ... Conclusion: Office pertubal hysteroscopic-guided diluted bupivacaine infusion could be used to manage endometriosis-associated CPP for at least 3 months.

3. brieflands.com brieflands.com/journals/semj/articles/85296

The Impact of Intraperitoneal Dexmedetomidine with ... This study was designed to evaluate the efficacy of intraperitoneal dexmedetomidine (DEX) combined with bupivacaine on postoperative pain in ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020729215002933

A randomized, placebo-controlled, double-blind study of ... Objective. To assess the effectiveness of hysteroscopic-guided pertubal diluted bupivacaine infusion for endometriosis-associated chronic pelvic pain (CPP).

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4631626/

Effect of Intraperitoneal Bupivacaine on Postoperative Pain ... To evaluate if the administration of intraperitoneal bupivacaine decreased postoperative pain in patients undergoing minimally invasive gynecologic and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06577233?term=AREA%5BConditionSearch%5D(endometriosis)%20AND%20AREA%5BOverallStatus%5D(RECRUITING)%20AND%20AREA%5BStudyType%5D(INTERVENTIONAL)&rank=9

Superior Hypogastric Nerve Plexus Block With Bupivacaine After ... A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to ...

7. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/542256

Superior Hypogastric Nerve Plexus Block With ... Various studies have shown improvement in pain with use of superior hypogastric nerve blocks in gynecologic surgery, but these effects have not ...

8. trialx.com trialx.com/clinical-trials/listings/305111/superior-hypogastric-nerve-plexus-block-with-bupivacaine-after-robotic-resection-of-endometriosis/

Superior Hypogastric Nerve Plexus Block With ... Various studies have shown improvement in pain with use of superior hypogastric nerve blocks in gynecologic surgery, but these effects have not ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12156479/

Advancements in Chronic Pelvic Pain Management - PMC Superior hypogastric plexus block (SHPB) has emerged as a promising adjunctive treatment for managing refractory CPP, targeting the nerve pathways responsible ...