Transdermal Fentanyl and Melatonin Patches for Postoperative Pain Relief

April 3, 2016 updated by: Dr.Ibrahim Mamdouh Esmat, Ain Shams University

Comparative Study Between Transdermal Fentanyl and Melatonin Patches on Postoperative Pain Relief After Lumber Laminectomy, a Double-blind, Placebo-controlled Trial

Seventy five patients, aged 18-50 years, ASA I and II undergoing elective single level lumber laminectomy under general anesthesia were included in this randomized controlled double-blind study. Patients were randomly divided into 3 groups 25 each, C group patients received transdermal placebo patch, TDF group (50μg/h) and TDM group (7 mg). Assessment of postoperative pain, sedation, hemodynamic variables such as HR and MAP, postoperative monitoring of arterial SpO2 and side effects (e.g. nausea, vomiting, pruritis, respiratory depression and hemodynamic instability) were done 30 minutes, 1, 2, 6 and 12 hours postoperatively. Postoperative Patient's and Surgeons' satisfaction, Intraoperative bleeding and plasma cortisol (µg / dl) postoperatively were also assessed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

75

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This study was designed to be a randomized, placebo-controlled, double-blind parallel study in which the patients, investigators, anesthesiologists and the surgeons were blinded to the given treatment. This study was conducted in Ain-Shams university hospitals, from March 2013 to April 2015 on 75 patients aged between 18 and 50 years old of both sex of ASA physical status I and II of 70-90 kg body weight and height 160-180 cm undergoing elective single level lumber laminectomy under general anesthesia. The study protocol was approved from the institutional ethical committee and written informed consent was obtained from all the patients.

Description

Inclusion Criteria:

  • 75 patients aged between 18 and 50 years old
  • Both sex of ASA physical status I and II
  • 70-90 kg body weight
  • Height 160-180 cm
  • Undergoing elective single level lumber laminectomy under general anesthesia.

Exclusion Criteria:

  • Patients with impaired kidney or liver functions
  • History of cardiac or central nervous system disease
  • History of drug or alcohol abuse
  • History of chronic pain or daily intake of analgesics
  • Uncontrolled medical disease (diabetes mellitus and hypertension)
  • History of intake of non-steroidal anti-inflammatory drugs or opioids within 24 h before surgery or allergy to the used medications
  • Coagulation defect
  • Local infection at the site of application of transdermal patch
  • Patient refusal or duration of surgery more than 120 minutes were excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
C group, (n=25)
C group, (n=25) each patient received transdermal placebo patch
Drug: Comparative study between transdermal fentanyl and melatonin patches on postoperative pain relief after lumber laminectomy
TDF group, (n=25)
TDF group, (n=25) each patient received transdermal therapeutic system-fentanyl 50μg/h
Drug: Comparative study between transdermal fentanyl and melatonin patches on postoperative pain relief after lumber laminectomy
TDM group, (n=25)
TDM group, (n=25) each patient received transdermal therapeutic system containing 7 mg of melatonin
Drug: Comparative study between transdermal fentanyl and melatonin patches on postoperative pain relief after lumber laminectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A mean difference of total analgesic (pethidine) consumption.
Time Frame: The total pethidine requirements (mg) 12 hours postop
The total pethidine requirements (mg) 12 hours postop

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

March 29, 2016

First Submitted That Met QC Criteria

March 31, 2016

First Posted (Estimate)

April 1, 2016

Study Record Updates

Last Update Posted (Estimate)

April 5, 2016

Last Update Submitted That Met QC Criteria

April 3, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 915

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Pain

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe