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

NCT ID: NCT04549818

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-10
• Study Completion Date: 2021-12-10

Brief Summary

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

sacral neuromodulation

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

Group Type: EXPERIMENTAL

sacral neuromodulation

Intervention Type: DEVICE

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

medical therapy

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

sacral neuromodulation

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Diab Fuad Hetta

anesthesia dep. south egypt cancer institute, El methaque st., assuit city, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

SECI2020

Identifier Type: -

Identifier Source: org_study_id