Transdermal Fentanyl and Melatonin Patches for Postoperative Pain Relief

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02726126

Enrollment

Registered

2016-04-01

Start date

2013-03-31

Completion date

2015-04-30

Last updated

2016-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

Transdermal fentanyl, Transdermal melatonin, Postoperative pain, lumber laminectomy, Relief

Brief summary

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.

Interventions

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

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026