Transdermal Fentanyl and Melatonin Patches for Postoperative Pain Relief

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

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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C group, (n=25)

C group, (n=25) each patient received transdermal placebo patch

Comparative study between transdermal fentanyl and melatonin patches on postoperative pain relief after lumber laminectomy

Intervention Type DRUG

TDF group, (n=25)

TDF group, (n=25) each patient received transdermal therapeutic system-fentanyl 50μg/h

Comparative study between transdermal fentanyl and melatonin patches on postoperative pain relief after lumber laminectomy

Intervention Type DRUG

TDM group, (n=25)

TDM group, (n=25) each patient received transdermal therapeutic system containing 7 mg of melatonin

Comparative study between transdermal fentanyl and melatonin patches on postoperative pain relief after lumber laminectomy

Intervention Type DRUG

Interventions

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Comparative study between transdermal fentanyl and melatonin patches on postoperative pain relief after lumber laminectomy

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No