Management Modalities of Chronic Pelvic Pain

NCT06719635 | Active Not Recruiting

• 1 other identifier: Pelvic Pain Management
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Chronic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Daily analgesic requirements

  At the end of the first 2 weeks, 1st month, 2nd month, 3rd month, and 6th month after the procedure.

• Associated adverse events

  At the end of the first month after the procedure.

Study Arms (2)

Laparoscopic Presacral Neurectomy

ACTIVE COMPARATOR

The patients will undergo Laparoscopic Presacral Neurectomy under general anesthesia.

Procedure: Laparoscopic Presacral Neurectomy

Fluoroscopically guided Superior Hypogastric Neurolysis

ACTIVE COMPARATOR

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

Interventions

Laparoscopic Presacral Neurectomy PROCEDURE

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.

Laparoscopic Presacral Neurectomy

Fluoroscopically guided Superior Hypogastric Plexus Neurolysis PROCEDURE

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.

Fluoroscopically guided Superior Hypogastric Neurolysis

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig university hospital

Zagazig, Al-Sharkia, 44519, Egypt

Location

Related Publications (4)

• 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.

  PMID: 8233527 BACKGROUND

• 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.

  PMID: 32654406 BACKGROUND

• 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.

  PMID: 32214294 BACKGROUND

• 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.

  PMID: 12615830 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Abdalla Mohamed Gouda, MD

  Department of Anesthesia, Intensive Care & Pain Management, Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 6, 2024
• Study Start: December 7, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2025-11

Locations

EG (1)