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

Assiut University

Status: Unknown

Conditions: Chronic Pain

Treatments: Device: sacral neuromodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04549818

SECI2020

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

sacral neuromodulation

Experimental group

Description:

Sacral neuromodulation group, 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

Treatment:

Device: sacral neuromodulation

medical therapy

No Intervention group

Description:

this group will be treated with sustained release morphine tablets for pain control