NCT02747628

Transdermal Nicotine and Melatonin Patches for Postoperative Pain Relief

Comparative Study Between Transdermal Nicotine and Melatonin Patches on Postoperative Pain Relief After Laparoscopic Cholecystectomy, a Double-blind, Placebo-controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Sixty female non-smoker patients, aged 18-50 years and ASA I and II undergoing elective laparoscopic cholecystectomy under general anesthesia were included in this randomized controlled double-blind study. Patients were randomly divided into 3 groups 20 each, C group patients received transdermal placebo patch, TDN group (15 mg/16 h) and TDM group (7 mg/8h). 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) 2 hours postoperatively were also assessed.

Conditions

• Postoperative Pain Relief

Interventions

Type	Name	Description
DRUG	Placebo	Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded.
DRUG	transdermal therapeutic system- nicotine.	Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded.
DRUG	transdermal therapeutic system- melatonin.	Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded.

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2016-04-22
• Last updated: 2020-08-25
• Results posted: 2020-08-20