Recruiting

Bupivacaine

Sponsor:

Baylor College of Medicine

Code:

NCT06577233

Conditions

Endometriosis

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Bupivacaine Hydrochloride

Normal saline

Study Details

Brief 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.

Conditions

Endometriosis

Study ID

NCT06577233

Start date

Aug 28, 2024

Status verified date

Aug, 2024

Completion date

Aug 31, 2025

Anticipated

Primary completion date

Apr 30, 2025

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 18-65 years old
  • Scheduled to undergo a robotic assisted resection of endometriosis

Exclusion Criteria:

  • Subjects who are part of a vulnerable population will be excluded including those who are prisoners, younger than 18 years old, pregnant, individuals with mental disabilities or cognitive impairment.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Bupivacaine Hydrochloride

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

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

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 and Locations

Central contacts

Locations

Texas Childrens Hospital Pavilion for Women

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Xiaoming Guan, PhD, MD

More Information

Sponsor

Baylor College of Medicine

Last update posted

Aug 18, 2025

Last verified

Aug, 2024

Keywords

  • Endometriosis, Postoperative Pain, Robotic Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2025-08-18.