Management Modalities of Chronic Pelvic Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-07

Study Completion Date

2026-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Laparoscopic Presacral Neurectomy

The patients will undergo Laparoscopic Presacral Neurectomy under general anesthesia.

Group Type ACTIVE_COMPARATOR

Laparoscopic Presacral Neurectomy

Intervention Type 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 Neurolysis

The patients will receive fluoroscopically guided Superior Hypogastric Plexus Neurolysis with Radiofrequency of the Sacral Roots 2,3,4.

Group Type ACTIVE_COMPARATOR

Fluoroscopically guided Superior Hypogastric Plexus Neurolysis

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No