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NCT06577233 · ClinicalTrials.gov registry record · Phase 4
Superior Hypogastric Nerve Plexus Block With Bupivacaine After Robotic Resection of Endometriosis
A Phase 4 study of Endometriosis, sponsored by Baylor College of Medicine.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06577233 is a Phase 4 study of Endometriosis that is actively recruiting participants, run by Baylor College of Medicine. The registered enrollment target is 60 participants, below the 263-participant average among 48 other Endometriosis trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06577233, a Phase 4 study of Endometriosis, is actively recruiting participants, sponsored by Baylor College of Medicine.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
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.
Conditions Studied
Interventions
- DRUG Normal saline
- DRUG Bupivacaine Hydrochloride
Study Locations (1)
Texas
- Texas Childrens Hospital Pavilion for Women - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-08-28 |
| Est. Completion | 2025-08-31 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06577233
The ClinicalTrials.gov registry entry for NCT06577233 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 263-participant average among 48 other Endometriosis trials with a reported enrollment target (77% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Endometriosis appearing as the primary indexed condition, and to 2 interventions - of which Normal saline is the first listed.
NCT06577233 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT06577233 about?
NCT06577233 is a clinical study titled "Superior Hypogastric Nerve Plexus Block With Bupivacaine After Robotic Resection of Endometriosis". 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 pos...
What is the current status of trial NCT06577233?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2024-08-28. Estimated completion is 2025-08-31.
What conditions does trial NCT06577233 study?
This clinical trial studies the following conditions: Endometriosis.
What interventions are being tested in trial NCT06577233?
The interventions under investigation include: Normal saline (DRUG), Bupivacaine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT06577233?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06577233 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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