Analgesic Efficacy of Sacral Neuromodulation for Pelvic Cancer Pain: A Preliminary Report

Assiut University44 enrolled

Overview

in this trial, we will test the analgesic efficacy of sacral neuromodulation for patients with pelvic cancer, complaining of chronic pelvic pain in comparison to medical treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Pain

Interventions

sacral neuromodulationDEVICE

Sacral neuromodulation group, N=22 will be treated with Stimulation of the sacral nerve roots by placement of a lead and generator, typically using an implanted InterStim® device that provides constant electrical stimulation to the S 2, 3 and 4 nerve roots, for 2-week trial stimulation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age, 18-70 * Pain localized to the pelvic and perineal region * The pain is due to pelvic cancer or chronic pelvic pain after pelvic surgery for cancer * The intensity of pain assessed by VAS (visual analogue pain scale) \> 7 * Importantly, the included participants should gain \> 50% reduction of their pain in response to sacral roots block, S2,3 and 4 with bupivacaine 0.5%, 2 ml for each root Exclusion Criteria: * Coagulopathy * Infection at site of maneuver * Abnormal Psychological behavior that interfere with integrity of obtained data

Outcomes

Primary Outcomes

The change of intensity of pain

The intensity of pain measured by VAS pain score (visual analogue pain scale) where 0= no pain and 10=the maximum tolerated pain

Time frame: The outcome will be measured at day 15 postoperatively.

Data from ClinicalTrials.gov

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