Bupivacaine for Endometriosis
Trial Summary
What is the purpose of this trial?
Endometriosis is a condition that causes significant pelvic pain and affects 10-15% of reproductive age women. Treatment options area both medical and surgical for pain relief, however with surgical options, past studies have demonstrated a higher risk of surgical complications as well as higher postoperative pain scores in women with endometriosis. Despite attempts to limit narcotic pain medications with enhanced recovery after surgery (ERAS) protocols, persistent opioid use after surgery is a national crisis, and it is important to explore multimodal options for pain relief. Various studies have shown improvement in pain with use of superior hypogastric nerve blocks in gynecologic surgery, but these effects have not yet been examined in the setting of a minimally invasive endometriosis resection. The goal of this clinical trial is to determine if a superior hypogastric nerve plexus block with 0.25% bupivacaine hydrochloride can decrease postoperative pain and opioid requirements in patients undergoing robotic assisted resection of endometriosis for the first week after surgery. Researchers will perform a superior hypogastric nerve plexus block by either injecting 0.25% bupivacaine hydrochloride (investigative treatment) or normal saline (placebo) in subjects who are undergoing a robotic assisted resection of endometriosis. To determine if postoperative pain is reduced, the subject will be asked to rate their pain score on the Visual Analog Scale (VAS) at 0 hours, 2 hours and 4 hours postop while in the Post-anesthesia Care Unit (PACU). They will then document their pain score each day on a form provided to them for 7 days after surgery. To determine the effect of this research study on postoperative opioid requirements, the subject will be asked to fill out a form documenting how many tablets of an opioid medication they took each day for a total of 7 days after surgery.
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 data supports the effectiveness of the treatment for endometriosis-related pain?
Research shows that the superior hypogastric plexus block can significantly reduce pain and improve the quality of life for patients with endometriosis-related chronic pelvic pain. In a study, patients experienced significant pain relief and better quality of life over a 24-week period without serious side effects.12345
Is bupivacaine safe for use in humans?
Bupivacaine, including its liposomal form (Exparel), has been studied for safety in various conditions. Research indicates that it is generally safe for use in humans, though some studies have noted potential nerve inflammation in animal models. Always consult with a healthcare provider for personalized advice.13678
Research Team
Xiaoming Guan, PhD, MD
Principal Investigator
Department Chair of Minimally Invasive Gynecologic Surgery
Eligibility Criteria
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
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
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
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
Follow-up
Participants are monitored for safety and effectiveness after treatment, including opioid use documentation
Treatment Details
Interventions
- Superior Hypogastric Nerve Plexus Block with Bupivacaine (Local Anesthetic)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baylor College of Medicine
Lead Sponsor