Analgesic Efficacy of Sacral Neuromodulation for Pelvic Cancer Pain: A Preliminary Report
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: 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 |
Device: 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
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No Intervention: medical therapy this group will be treated with sustained release morphine tablets for pain control |
Outcome Measures
Primary Outcome Measures
- The change of intensity of pain [The outcome will be measured at day 15 postoperatively.]
The intensity of pain measured by VAS pain score (visual analogue pain scale) where 0= no pain and 10=the maximum tolerated pain
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age, 18-70
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Pain localized to the pelvic and perineal region
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The pain is due to pelvic cancer or chronic pelvic pain after pelvic surgery for cancer
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The intensity of pain assessed by VAS (visual analogue pain scale) > 7
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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:
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Coagulopathy
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Infection at site of maneuver
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Abnormal Psychological behavior that interfere with integrity of obtained data
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Assiut University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SECI2020