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OpenTrials
Completed

NCT Number: NCT01666379

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

  1. 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

  1. 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

Interested in participating?

Completed

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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.

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