Clinical trial NCT02726126: Transdermal Fentanyl and Melatonin Patches for Postoperative Pain Relief
Official title: Comparative Study Between Transdermal Fentanyl and Melatonin Patches on Postoperative Pain Relief After Lumber Laminectomy, a Double-blind, Placebo-controlled Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Keywords: Transdermal fentanyl
Transdermal melatonin
Postoperative pain
lumber laminectomy
Relief
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2016-04-01
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: A mean difference of total analgesic (pethidine) consumption.
timeFrame: The total pethidine requirements (mg) 12 hours postop
Secondary outcomes:
Other outcomes:
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Study officials:
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