RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Superior Hypogastric Nerve Plexus Block With Bupivacaine for Postoperative Pain Reduction Following Robotic Assisted Resection of Endometriosis: A Randomized Control Trial

Quick Facts

Study Start:2024-08-28
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06577233

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18-65 years old
  2. * Scheduled to undergo a robotic assisted resection of endometriosis
  1. * 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.

Contacts and Locations

Study Contact

Ann Tims
CONTACT
8328267464
atims@bcm.edu

Principal Investigator

Xiaoming Guan, PhD, MD
PRINCIPAL_INVESTIGATOR
Department Chair of Minimally Invasive Gynecologic Surgery

Study Locations (Sites)

Texas Childrens Hospital Pavilion for Women
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

  • Xiaoming Guan, PhD, MD, PRINCIPAL_INVESTIGATOR, Department Chair of Minimally Invasive Gynecologic Surgery

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-28
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2024-08-28
Study Completion Date2025-07-31

Terms related to this study

Keywords Provided by Researchers

  • Endometriosis, Postoperative Pain, Robotic Surgery

Additional Relevant MeSH Terms

  • Endometriosis