Pain Management After Forefoot Surgery

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Fentanyl

• Registration Number: NCT01666379
• Lead Sponsor: Turku University Hospital

Brief Summary

The purpose of this study was to compare the efficacy of transdermal fentanyl to placebo both administered together with peroral nonsteroidal antiinflammatory drug (NSAID) and paracetamol in treatment of postoperative pain after hallux valgus or hallux rigidus surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Study First Submitted: 2012-07-19
• Status Verified: 2012-08
• Study First Submitted QC: 2012-08-10
• Last Update Submitted: 2012-08-10
• Study First Posted: 2012-08-16
• Last Update Posted: 2012-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• unilateral hallux valgus or hallux rigidus surgery
• 18-75 yrs old
• ASA I-III

Exclusion Criteria

• previous history of intolerance to the study drug
• history of alcoholism
• drug abuse
• psychological or other emotional problems that are likely to invalidate informed consent
• sleep apnoea
• BMI ≥ 35 kg/m2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fentanyl	Fentanyl	-

Primary Outcome Measures

Name	Time	Method
Consumption of rescue opioid	on the 1st postoperative day	Also adverse effects were evaluated but this evaluation was not the first or secondary outcome measure

Secondary Outcome Measures

Name	Time	Method
Pain on a numerical scale	on the 1st postoperative day	The adverse effects were evaluated but the evaluation was not the first or secondary outcome measure

Trial Locations

Locations (1)

The Department of Anaesthesiology, Intensive Care, Emergency Care and Pain Management of Turku University Hospital; 🇫🇮 Turku, Finland