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

NCT04549818 | Unknown

• 1 other identifier: SECI2020
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

  The outcome will be measured at day 15 postoperatively.

Study Arms (2)

sacral neuromodulation

EXPERIMENTAL

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

Device: sacral neuromodulation

medical therapy

NO INTERVENTION

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

Interventions

sacral neuromodulation 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

sacral neuromodulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Coagulopathy
• Infection at site of maneuver
• Abnormal Psychological behavior that interfere with integrity of obtained data

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: anesthesia dep. south egypt cancer institute, El methaque st., assuit city, Egypt

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 16, 2020
• Study Start: September 10, 2020
• Primary Completion: September 10, 2021
• Study Completion: December 10, 2021
• Last Updated: September 16, 2020

Record last verified: 2020-09