NCT01666379

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 postoperative-pain

Timeline
Completed

Started Jan 2009

Typical duration for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2012

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 16, 2012

Completed
Last Updated

August 16, 2012

Status Verified

August 1, 2012

Enrollment Period

1.8 years

First QC Date

July 19, 2012

Last Update Submit

August 10, 2012

Conditions

Postoperative Pain

Keywords

Hallux valgusForefoottransdermal fentanyl

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Pain on a numerical scale

    on the 1st postoperative day

Study Arms (2)

Fentanyl

EXPERIMENTAL
Drug: Fentanyl

placebo

PLACEBO COMPARATOR

Interventions

FentanylDRUG
Fentanyl

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • unilateral hallux valgus or hallux rigidus surgery
  • yrs old
  • ASA I-III

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Turku, Finland

Location

MeSH Terms

Conditions

Pain, PostoperativeHallux Valgus

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsFoot DeformitiesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

July 19, 2012

First Posted

August 16, 2012

Study Start

January 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

August 16, 2012

Record last verified: 2012-08

Locations

FI(1)