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Pain Management After Forefoot Surgery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01666379
Enrollment
60
Registered
2012-08-16
Start date
2009-01-31
Completion date
2010-11-30
Last updated
2012-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

Hallux valgus, Forefoot, transdermal fentanyl

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.

Interventions

DRUGFentanyl

Sponsors

Turku University Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Consumption of rescue opioidon the 1st postoperative dayAlso adverse effects were evaluated but this evaluation was not the first or secondary outcome measure

Secondary

MeasureTime frameDescription
Pain on a numerical scaleon the 1st postoperative dayThe adverse effects were evaluated but the evaluation was not the first or secondary outcome measure

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026