Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06719635

Management Modalities of Chronic Pelvic Pain

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

21 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig university hospital

Zagazig, Al-Sharkia, 44519, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Visual analogue pain score

    Time frame: At the end of the first month after the procedure.

    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.

Secondary outcomes

  1. Daily analgesic requirements

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

    Daily analgesic requirements at the end of the first 2 weeks, 1st month, 2nd month, 3rd month, and 6th month after the procedure.

  2. Associated adverse events

    Time frame: At the end of the first month after the procedure.

    Any related adverse events "e.g. hypotension, bleeding or neurological deficits" in the first month after the procedure.

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 6, 2024
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.