NCT01348984

Brief Summary

The purpose of this study is to determine whether transdermal fentanyl patch

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_4 postoperative-pain

Timeline
Completed

Started Apr 2010

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2011

Completed
Last Updated

May 6, 2011

Status Verified

February 1, 2010

Enrollment Period

6 months

First QC Date

May 4, 2011

Last Update Submit

May 5, 2011

Conditions

Postoperative Pain

Keywords

postoperativepain scoremorphine consumption

Outcome Measures

Primary Outcomes (1)

  • intravenous morphine consumption

    48 hours

Secondary Outcomes (1)

  • Pain score

    48 hours

Study Arms (2)

group 1

ACTIVE COMPARATOR

group 1 = transdermal fentanyl patch

Drug: transdermal fentanyl patch

group 2

PLACEBO COMPARATOR

placebo patch

Drug: placebo patch

Interventions

transdermal fentanyl patchDRUG

TFP = transdermal fentanyl patch (50 microgram/hour)

Also known as: Duragesic
group 1
placebo patchDRUG

group 2 = placebo patch

Also known as: Duragesic
group 2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • ASA class 3-4
  • Known allergy to any of the drugs to be used, eg. TFPs ,MO
  • History of substance or alcohol abuse, and tolerance or dependence on opioids
  • Can not use PCA
  • Contraindication for spinal anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Srinagarind Hospital, Faculty of Medicine, Khon Kaen University

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Thepakorn Sathitkarnmanee, MD

    Faculty of Medicine, Khon Kaen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 4, 2011

First Posted

May 6, 2011

Study Start

April 1, 2010

Primary Completion

October 1, 2010

Study Completion

December 1, 2010

Last Updated

May 6, 2011

Record last verified: 2010-02

Locations

TH(1)