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Transdermal Fentanyl Patch for Postoperative Analgesia After Abdominal Surgery: a Randomized Placebo-controlled Trial

NCT ID: NCT01726530

Last Updated: 2012-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-08-31

Brief Summary

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Abdominal surgery causes severe postoperative pain. Multi-modal pain therapy is usually applied but there is no perfect choice. It depends on physician's skill and situation. The best regimen is patient-controlled analgesia, but it requires an expensive equipment. Transdermal fentanyl patch, usually used in chronic pain relief, can steadily release fentanyl into blood stream for 72 hours, but it has slow onset of 12 hours.

Hypothesis: If Transdermal fentanyl patch is applied 10-12 hours before surgery, it may provide good analgesia for 72 hours.

Detailed Description

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Conditions

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Postoperative Pain Relief

Keywords

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transdermal fentanyl patch, postoperative pain,

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Transdermal fentanyl patch

Transdermal fentanyl patch, 50 mcg/hour, was attached to the patient's chest wall at 10 pm the day before surgery

Group Type ACTIVE_COMPARATOR

transdermal fentanyl patch (50 mcg/hour)

Intervention Type DRUG

Placebo

Placebo patch was attached to the patient's chest wall at 10 pm the day before surgery

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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transdermal fentanyl patch (50 mcg/hour)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Duragesic

Eligibility Criteria

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Inclusion Criteria

* age =\>18 years
* scheduled for abdominal surgery

Exclusion Criteria

* ASA class \> 3
* Known allergy to fentanyl or morphine
* History of substance or alcohol abuse, and tolerance or dependence on opioids
* Combined epidural block
* Can't use PCA, abnormal renal / liver function
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Khon Kaen University

OTHER

Sponsor Role lead

Responsible Party

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Thepakorn Sathitkarnmanee

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thepakorn Sathitkarnmanee, MD.

Role: STUDY_CHAIR

Khon Kaen University

Locations

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Srinagarind hospital

Khon Kaen, Changwat Khon Kaen, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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HE541094

Identifier Type: -

Identifier Source: org_study_id