Management Modalities of Chronic Pelvic Pain

N/AActive Not RecruitingNCT06719635

Zagazig University62 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pain, Chronic

Interventions

Laparoscopic Presacral NeurectomyPROCEDURE

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 NeurolysisPROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Zagazig university hospital

Zagazig, Al-Sharkia, Egypt

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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.

Time frame: 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.

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

Data from ClinicalTrials.gov

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