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

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ClinicalTrials.gov Identifier: NCT04549818
Recruitment Status : Not yet recruiting
First Posted : September 16, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Diab Fuad Hetta, Assiut University

Study Description
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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
Chronic Pain Device: sacral neuromodulation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Sacral Neuromodulation Relieve Chronic Pelvic Cancer Pain, Compared With Medical Treatment?
Estimated Study Start Date : September 10, 2020
Estimated Primary Completion Date : September 10, 2021
Estimated Study Completion Date : December 10, 2021
Arms and Interventions
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Arm Intervention/treatment
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
No Intervention: medical therapy
this group will be treated with sustained release morphine tablets for pain control


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Diab Fuad Hetta, anesthesia dep. south egypt cancer institute, El methaque st., assuit city, Egypt, Assiut University
ClinicalTrials.gov Identifier: NCT04549818    
Other Study ID Numbers: SECI2020
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pelvic Neoplasms
Chronic Pain
Cancer Pain
Pain
 Neurologic Manifestations
Neoplasms by Site
Neoplasms