Pain Management After Forefoot Surgery

Turku University Hospital (TYKS)

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT01666379

ForefootFenta vs.2

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

60 participants in 2 patient groups, including a placebo group

Fentanyl

Experimental group

Treatment:

Drug: Fentanyl

placebo

Placebo Comparator group