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

NCT06577233 | Recruiting Phase 4 FDA Drug

• 1 other identifier: H-55139
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Endometriosis, Postoperative Pain, Robotic Surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

  Postoperative pain levels as characterized by the Visual Analog Scale (VAS)

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

Secondary Outcomes (1)

• Opioid use

  The first 7 days after surgery

Study Arms (2)

Investigative Treatment

EXPERIMENTAL

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.

Drug: Bupivacaine Hydrochloride

Placebo

PLACEBO COMPARATOR

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.

Drug: Normal saline

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

Also known as: Marcaine

Investigative Treatment

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

Also known as: 0.9% Normal Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Childrens Hospital Pavilion for Women

Houston, Texas, 77030, United States

RECRUITING

Related Publications (6)

• Zakim D, Herman RH. The effect of intravenous fructose and glucose on the hepatic alpha-glycerophosphate concentration in the rat. Biochim Biophys Acta. 1968 Oct 15;165(3):374-9. doi: 10.1016/0304-4165(68)90215-8. No abstract available.

  PMID: 5737931 BACKGROUND

• Brunes M, Johannesson U, Habel H, Forsgren C, Moawad G, Ek M. Peri- and postoperative outcomes in patients with endometriosis undergoing hysterectomy. Eur J Obstet Gynecol Reprod Biol. 2022 May;272:104-109. doi: 10.1016/j.ejogrb.2022.02.180. Epub 2022 Mar 9.

  PMID: 35299012 BACKGROUND

• Kanellos P, Nirgianakis K, Siegenthaler F, Vetter C, Mueller MD, Imboden S. Postoperative Pain Is Driven by Preoperative Pain, Not by Endometriosis. J Clin Med. 2021 Oct 15;10(20):4727. doi: 10.3390/jcm10204727.

  PMID: 34682850 BACKGROUND

• Meyer LA, Lasala J, Iniesta MD, Nick AM, Munsell MF, Shi Q, Wang XS, Cain KE, Lu KH, Ramirez PT. Effect of an Enhanced Recovery After Surgery Program on Opioid Use and Patient-Reported Outcomes. Obstet Gynecol. 2018 Aug;132(2):281-290. doi: 10.1097/AOG.0000000000002735.

  PMID: 29995737 BACKGROUND

• Aytuluk HG, Kale A, Astepe BS, Basol G, Balci C, Colak T. Superior Hypogastric Plexus Blocks for Postoperative Pain Management in Abdominal Hysterectomies. Clin J Pain. 2020 Jan;36(1):41-46. doi: 10.1097/AJP.0000000000000767.

  PMID: 31567396 BACKGROUND

• De Silva P, Daniels S, Bukhari ME, Choi S, Liew A, Rosen DMB, Conrad D, Cario GM, Chou D. Superior Hypogastric Plexus Nerve Block in Minimally Invasive Gynecology: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2022 Jan;29(1):94-102. doi: 10.1016/j.jmig.2021.06.017. Epub 2021 Jun 29.

  PMID: 34197956 BACKGROUND

MeSH Terms

Conditions

Endometriosis; Pain, Postoperative

Interventions

Bupivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Xiaoming Guan, PhD, MD

  Department Chair of Minimally Invasive Gynecologic Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann Tims

CONTACT

8328267464; atims@bcm.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The subject will be told that the study is regarding postoperative pain control and superior hypogastric nerve plexus blocks with bupivacaine hydrochloride and that they will be randomized into the placebo group or the intervention group, but will be blinded to their assignment. They will be informed they have a 50% chance of being randomized to the investigative treatment group and a 50% chance of being chance of being randomized to the placebo group. Risks and benefits of the procedure as well as consent for the procedure will be obtained. The subject will be assigned a number to de-identify the data and then be randomized using a computer generator and RedCap. The practitioner will be aware of the group that is assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chief of Minimally Invasive Gynecologic Surgery

Model Details: This study will be a randomized single blind clinical trial where the participant will be blinded to whether they received a superior hypogastric nerve block with 0.25% Bupivacaine Hydrochloride (investigative treatment) or 0.9% normal saline (placebo). The researcher will not be blinded and will know which arm the participant has been randomized to. Randomization will be performed by a computer generator in RedCap.

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: August 28, 2024
• Primary Completion: April 30, 2025
• Study Completion: August 31, 2025
• Last Updated: August 18, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)