Pain Management After Forefoot Surgery | NCT01666379

Studies
Pain Management After Forefoot Surgery

NCT01666379

Sponsor

Turku University Hospital

Status

Completed

Last Update Posted

Aug 16, 2012Estimated

Enrollment

60Actual

Phase

Phase 4

Conditions

Postoperative Pain

Interventions

Fentanyl

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Nov 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

Jul 19, 2012

First Submission Date that Met QC Criteria

Aug 10, 2012

First Posted Date

Aug 16, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 10, 2012

Last Update Posted Date

Aug 16, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Label	Type	Description	Intervention Names
Fentanyl	Experimental		Drug: Fentanyl
placebo	Placebo Comparator

Name	Type	Description	Arm Group Labels	Other Names
Fentanyl	Drug		Fentanyl

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Pain on a numerical scale	The adverse effects were evaluated but the evaluation was not the first or secondary outcome measure	on the 1st postoperative day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Department of Anaesthesiology, Intensive Care, Emergency Care and Pain Management of Turku University Hospital		Turku			Finland

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative
D006215	Hallux Valgus

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005283	Fentanyl

Ancestor Terms

ID	Term
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided