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

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT06577233
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Bupivacaine Hydrochloride — DRUG
    10cc of 0.25% Bupivacaine Hydrochloride will be injected into the peritoneum overlying the superior hypogastric nerve plexus with a laparoscopic needle during robotic surgery
  • Normal saline — DRUG
    10cc of 0.9% normal saline will be injected into the peritoneum overlying the superior hypogastric nerve plexus with a laparoscopic needle during robotic surgery

Study Details

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.

Key Dates

Start date
Aug 28, 2024
Status verified
Aug 2024
Primary completion
Apr 30, 2025
Completion
Aug 31, 2025

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Investigative Treatment
    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.
  • Placebo Comparator: Placebo
    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.

Primary Outcome Measure

Postoperative pain [ Time Frame: Postoperative pain level documented at 0, 2 and 4 hours after surgery, then once a day for 7 days after surgery. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Childrens Hospital Pavilion for WomenHoustonTexas77030
Xiaoming Guan, PhD, MD
[email protected]
973-330-2602
Xiaoming Guan, PhD, MD (PRINCIPAL_INVESTIGATOR)
Emily A Sendukas, MD (SUB_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Endometriosis
By specialty
Women's healthFertility
By research site
Texas Childrens Hospital Pavilion for Women· Houston, TX

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