Transdermal Fentanyl and Melatonin Patches for Postoperative Pain Relief

Study Overview
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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.

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Comparative study between transdermal fentanyl and melatonin patches on postoperative pain relief after lumber laminectomy


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| C group, (n=25)<br>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<br> <br> |
| TDF group, (n=25)<br>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<br> <br> |
| TDM group, (n=25)<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transdermal fentanyl, Transdermal melatonin, Postoperative pain, lumber laminectomy, Relief