Transdermal Fentanyl and Melatonin Patches for Postoperative Pain Relief

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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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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

Drug

Primary outcomes

A mean difference of total analgesic (pethidine) consumption.

Time frame: The total pethidine requirements (mg) 12 hours postop

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Apr 1, 2016
Registry last updated: Apr 5, 2016

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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