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Clinical Trials/NCT04549818
NCT04549818
Unknown
N/A

Does Sacral Neuromodulation Relieve Chronic Pelvic Cancer Pain, Compared With Medical Treatment?

Assiut University0 sites44 target enrollmentSeptember 10, 2020
ConditionsChronic Pain

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Assiut University
Enrollment
44
Primary Endpoint
The change of intensity of pain
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 10, 2020
End Date
December 10, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Diab Fuad Hetta

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

Assiut University

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

Outcomes

Primary Outcomes

The change of intensity of pain

Time Frame: 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

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