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Superior Hypogastric Nerve Plexus Block With Bupivacaine After Robotic Resection of Endometriosis

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clinicaltrials.gov/study/NCT06577233
Is a
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Clinical study
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Clinical Study attributes

NCT Number
NCT065772330
Health Conditions in Trial
Endometriosis
Endometriosis
0
Trial Recruitment Size
600
Trial Sponsor
Baylor College of Medicine
Baylor College of Medicine
0
Clinical Trial Start Date
August 28, 2024
0
Primary Completion Date
April 30, 2025
0
Study Completion Date
July 31, 2025
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Drug0
Interventional Trial Phase
Phase 40
Official Name
Superior Hypogastric Nerve Plexus Block With Bupivacaine for Postoperative Pain Reduction Following Robotic Assisted Resection of Endometriosis: A Randomized Control Trial0
Last Updated
August 29, 2024
0
Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Single0
Masked Party
Participant0

Other attributes

Intervention Treatment
Normal saline0
Bupivacaine Hydrochloride0
Study summary

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.

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