Effect of Rufinamide on Chronic Postthoracotomy Pain Syndrome

Phase 2

Withdrawn

• Conditions: Peripheral Nerve Injuries; Pain
• Interventions: Drug: Rufinamide

• Registration Number: NCT02095899
• Lead Sponsor: University of Zurich

Brief Summary

The purpose of this study is to test if rufinamide has an effect on chronic neuropathic pain in patients with a post thoracotomy pain syndrome.

Detailed Description

Patients with chronic neuropathic pain after thoracic surgery will be evaluated and treated with oxycodone. Patients with a stable analgesic regimen, not reaching a good pain relief will be randomized to receive Rufinamide (Inovelon)vs. Placebo as an ad-on treatment to oxycodone. Neurophysiological and clinical data will be monitored.

Study Timeline

• Study First Submitted: 2014-02-14
• Study Start: 2014-03
• Study First Submitted QC: 2014-03-25
• Study First Posted: 2014-03-26
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-20
• Last Update Posted: 2015-07-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rufinamide	Rufinamide	- oral Rufinamide administration as ad-on to Oxycodone
Manitol	Rufinamide	- oral Placebo administration - as ad-on to Oxycodone

Primary Outcome Measures

Name	Time	Method
Area of punctuate hyperalgesia immediately after topical capsaicin.	2h after capsaicin removal	The primary variable to test is the area of punctuate hyperalgesia after topical capsaicin application in patients treated with rufinamide versus placebo.

Trial Locations

Locations (1)

University Hospital Zurich, Institut of Anaesthesiology; 🇨🇭 Zurich, ZH, Switzerland