Management Modalities of Chronic Pelvic Pain

Laparoscopic Presacral Neurectomy Versus Fluoroscopically Guided Superior Hypogastric Plexus Neurolysis for Treatment of Chronic Pelvic Pain: A Double-Blind, Randomized Controlled Trial.

Chronic pelvic pain remains a challenging disorder to treat because of the complexities of pain sensation and unclear etiology. Standard medical and surgical treatments seldom prove effective at improving quality of life and pain intensity among affected women.

Study Overview

• Status: Active, not recruiting
• Conditions: Pain, Chronic
• Intervention / Treatment: Procedure: Laparoscopic Presacral Neurectomy; Procedure: Fluoroscopically guided Superior Hypogastric Plexus Neurolysis

Detailed Description

Chronic pelvic pain remains a challenging disorder to treat because of the complexities of pain sensation and unclear etiology. Standard medical and surgical treatments seldom prove effective at improving quality of life and pain intensity among affected women. The current study will investigate whether Laparoscopic Presacral Neurectomy or Fluoroscopically Guided Superior Hypogastric Plexus Neurolysis is more effective for treating chronic pelvic pain.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Al-Sharkia
    • Zagazig, Al-Sharkia, Egypt, 44519
      • Zagazig university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient acceptance.
• Body mass index < 35 kg/m2.
• Adult patients with chronic pelvic and perineal pain due to pelvic cancer.
• Visual Analog Scale pain score ≥ 5 on a 0-10 scale despite treatment with a standard analgesic.

Exclusion Criteria:

• Uncooperative patient.
• Patients with coagulopathy, infection at the site of injection, severe cardiac compromise, or intolerance to sympathetic block.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Laparoscopic Presacral Neurectomy; The patients will undergo Laparoscopic Presacral Neurectomy under general anesthesia.	Procedure: Laparoscopic Presacral Neurectomy; Laparoscopy will be performed under general anesthesia. Then, nerve plexuses will be identified and freed from their underlying tissue, which contains the left common iliac and middle sacral veins. This will be followed by cauterization and cutting of the nerve plexuses.
Active Comparator: Fluoroscopically guided Superior Hypogastric Neurolysis; The patients will receive fluoroscopically guided Superior Hypogastric Plexus Neurolysis with Radiofrequency of the Sacral Roots 2,3,4.	Procedure: Fluoroscopically guided Superior Hypogastric Plexus Neurolysis; The patients will receive fluoroscopically guided Superior Hypogastric Plexus Neurolysis using 3 mL of 75% ethanol and Radiofrequency of the Sacral nerve Roots 2-4.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue pain score	The percentage of patients who achieved > 50% decline in their Visual analogue pain score "from the baseline value" before intervention at the end of the first month.	At the end of the first month after the procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily analgesic requirements	Daily analgesic requirements at the end of the first 2 weeks, 1st month, 2nd month, 3rd month, and 6th month after the procedure.	At the end of the first 2 weeks, 1st month, 2nd month, 3rd month, and 6th month after the procedure.
Associated adverse events	Any related adverse events "e.g. hypotension, bleeding or neurological deficits" in the first month after the procedure.	At the end of the first month after the procedure.

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Abdalla Mohamed Gouda, MD, Department of Anesthesia, Intensive Care & Pain Management, Zagazig University

Publications and helpful links

General Publications

• Ghai V, Subramanian V, Jan H, Pergialiotis V, Thakar R, Doumouchtsis SK; CHORUS: An International Collaboration for Harmonising Outcomes, Research, Standards in Urogynaecology, Women's Health. A systematic review on reported outcomes and outcome measures in female idiopathic chronic pelvic pain for the development of a core outcome set. BJOG. 2021 Mar;128(4):628-634. doi: 10.1111/1471-0528.16412. Epub 2020 Sep 1.
• de Leon-Casasola OA, Kent E, Lema MJ. Neurolytic superior hypogastric plexus block for chronic pelvic pain associated with cancer. Pain. 1993 Aug;54(2):145-151. doi: 10.1016/0304-3959(93)90202-Z.
• Hetta DF, Mohamed AA, Abdel Eman RM, Abd El Aal FA, Helal ME. Pulsed Radiofrequency of the Sacral Roots Improves the Success Rate of Superior Hypogastric Plexus Neurolysis in Controlling Pelvic and Perineal Cancer Pain. Pain Physician. 2020 Mar;23(2):149-157.
• Soysal ME, Soysal S, Gurses E, Ozer S. Laparoscopic presacral neurolysis for endometriosis-related pelvic pain. Hum Reprod. 2003 Mar;18(3):588-92. doi: 10.1093/humrep/deg127.

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 2, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Actual): December 6, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain
• Other Study ID Numbers: Pelvic Pain Management

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No