Pain Management After Forefoot Surgery

Postoperative Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01666379
• Other study ID #: ForefootFenta vs.2
• Status: Completed
• Phase: Phase 4
• First received: July 19, 2012
• Last updated: August 10, 2012
• Start date: January 2009
• Est. completion date: November 2010

Study information

• Verified date: August 2012
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines AgencyEuropean Union: European Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Fentanyl

Locations

Country	Name	City	State
Finland	The Department of Anaesthesiology, Intensive Care, Emergency Care and Pain Management of Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consumption of rescue opioid	Also adverse effects were evaluated but this evaluation was not the first or secondary outcome measure	on the 1st postoperative day	No
Secondary	Pain on a numerical scale	The adverse effects were evaluated but the evaluation was not the first or secondary outcome measure	on the 1st postoperative day	No