Management Modalities of Chronic Pelvic Pain

Not Applicable

Active, not recruiting

• Conditions: Pain, Chronic

• Registration Number: NCT06719635
• Lead Sponsor: Zagazig University

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.

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 Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-02
• Study First Posted: 2024-12-06
• Study Start: 2024-12-07
• Last Update Submitted: 2024-12-14
• Last Update Posted: 2024-12-18
• Primary Completion: 2025-10
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual analogue pain score	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 Outcome Measures

Name	Time	Method
Daily analgesic requirements	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.
Associated adverse events	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.

Trial Locations

Locations (1)

Zagazig university hospital; 🇪🇬 Zagazig, Al-Sharkia, Egypt