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Completed

NCT Number: NCT01726530

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

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.

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Key information

Conditions

Postoperative Pain Relief Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Srinagarind hospital

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transdermal fentanyl patch (50 mcg/hour)

Drug

Other names: Duragesic

Placebo

Drug

Primary outcomes

  1. morphine consumption

    Time frame: 24 hours

    Compare the cumulative morphine consumption during 24 hours postoperative of both study and control groups.

Secondary outcomes

  1. morphine consumption

    Time frame: 48 and 72 hours

    Compare the cumulative morphine consumption during 48 and 72 hours postoperative of both study and control groups.

Other outcomes

  1. side effects

    Time frame: 72 hours

    Compare the side effects, i.e.nausea, vomiting, itching, respiratory depression during 72 hours postoperative of both study and control groups.

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Nov 15, 2012
Registry last updated
Nov 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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