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

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Pain
• Intervention / Treatment: Device: sacral neuromodulation

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 10, 2020
• Primary Completion (ANTICIPATED): September 10, 2021
• Study Completion (ANTICIPATED): December 10, 2021

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: September 12, 2020
• First Posted (ACTUAL): September 16, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 12, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Pain; Neurologic Manifestations; Chronic Pain; Pelvic Neoplasms; Cancer Pain
• Other Study ID Numbers: SECI2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No