Pain Management After Forefoot Surgery

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.

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Key information

Conditions

Postoperative Pain Foot Deformities Hallux Valgus Musculoskeletal Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Department of Anaesthesiology, Intensive Care, Emergency Care and Pain Management of Turku University Hospital

Turku, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl

Drug

Primary outcomes

Consumption of rescue opioid

Time frame: on the 1st postoperative day

Also adverse effects were evaluated but this evaluation was not the first or secondary outcome measure

Secondary outcomes

Pain on a numerical scale

Time frame: on the 1st postoperative day

The adverse effects were evaluated but the evaluation was not the first or secondary outcome measure

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Registry information

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Aug 16, 2012
Registry last updated: Aug 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed