Capsaicin Patch 8 % for the Treatment of Persistent Pain After Inguinal Herniotomy

Phase 3

Terminated

• Conditions: Persistent Pain After Inguinal Herniotomy
• Interventions: Drug: capsaicin patch (qutenza); Drug: Placebo

• Registration Number: NCT01699854
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

In the present study the investigators intend to investigate analgesic and sensory effects of a capsaicin patch 8 %(Qutenza) in patients with severe post-herniotomy pain and sensory abnormalities in the skin.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-09-21
• Study First Submitted QC: 2012-10-03
• Study First Posted: 2012-10-04
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-25
• Last Update Posted: 2014-02-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients ASA (American Society´s of Anesthesiology´s classification) scores I-III
• Severe post-herniotomy pain for more than six months and with severe pain (numerical rating scale [NRS] 0-10 points) during rest or during movement > 5.

Exclusion Criteria

• History of an allergic reaction or intolerance to capsaicin or vehicle ingredients in the patches
• Severe cardiac impairment, e.g., NYHA (New York Heart Association) Class ≥ III
• Inflamed or injured skin at the application site
• Signs of cognitive impairment
• Known drug or ethanol abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
capsaicin patch	capsaicin patch (qutenza)	-
placebo patch	Placebo	-

Primary Outcome Measures

Name	Time	Method
Pain change capsaicin vs. placebo patch treatment	Pain intensity assessed at baseline and at 1,2,3 months follow-up	Summed pain intensity (SPI) is calculated as median pain intensities at rest, during transition from the supine lying to the standing erect position, and auto-palpation twice each day for the last 3 days at baseline and at 1 months, 2 months and 3 months during follow-up. The primary outcome measure is the maximum difference between the summed pain intensity differences (SPID) for the phases: Baseline, 1 month, 2 month or 3 month. Δ SPID is then calculated as the difference in SPID between capsaicin and placebo treated patients.

Secondary Outcome Measures

Name	Time	Method
Changes in HADS (Hospital Anxiety and Depression Scale) score
Changes in QST (Quantitative sensory testing)
Changes in intraepidermal nerve fiber density
Changes in AAS (Activities Assessment Scale) score
Changes in S-LANSS (Leeds self-assessment of neuropathic symptoms and signs)
Subgroup analysis for pain change(summed pain intensity differences (SPID) capsaicin patch vs. placebo are made for patients with thermal hypoesthesia and thermal normo/hyperesthesia
Changes in sleep (Sleep Interference Scale) score
Changes in PCS (Pain Catastrophizing Scale) score

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Copenhagen Ø, Denmark