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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04549818
Collaborator
(none)
44
2
15

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
  • Device: sacral neuromodulation
N/A

Study Design

Study Type:
Interventional
Anticipated 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?
Anticipated Study Start Date :
Sep 10, 2020
Anticipated Primary Completion Date :
Sep 10, 2021
Anticipated Study Completion Date :
Dec 10, 2021

Arms and Interventions

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

Primary Outcome Measures

  1. 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

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Sep 16, 2020
Last Update Posted:
Sep 16, 2020
Last Verified:
Sep 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 16, 2020