Transdermal Nicotine and Melatonin Patches for Postoperative Pain Relief

Phase 4

Completed

• Conditions: Postoperative Pain Relief
• Interventions: Drug: transdermal therapeutic system- melatonin.; Drug: transdermal therapeutic system- nicotine.; Drug: Placebo

• Registration Number: NCT02747628
• Lead Sponsor: Ain Shams University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Study First Submitted: 2016-04-01
• Study First Submitted QC: 2016-04-19
• Study First Posted: 2016-04-22
• Status Verified: 2020-08
• Results First Submitted: 2020-08-10
• Results First Submitted QC: 2020-08-10
• Results First Posted: 2020-08-20
• Last Update Submitted: 2020-08-23
• Last Update Posted: 2020-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• 60 female patients.
• non-smoker patients.
• aged between 18 and 50 years old.
• ASA physical status I and II.
• 70-90 kg body weight and height 160-180 cm.
• undergoing elective laparoscopic cholecystectomy under general anesthesia.

Exclusion Criteria

• Patients with impaired kidney or liver functions.
• history of cardiac or central nervous system disease.
• history of smoking.
• 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.
• allergy to the used medications.
• coagulation defect.
• local infection at the site of application of transdermal patch.
• patient's refusal.
• duration of surgery more than 120 minutes.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TDM group, (n=20)	transdermal therapeutic system- melatonin.	TDM group (n=20) each patient received transdermal therapeutic system- melatonin (7 mg/8h),melatonin sleep patch from Respro Labs ™ containing 7 mg of melatonin placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy.
TDN group, (n=20)	transdermal therapeutic system- nicotine.	TDN group (n=20) each patient received transdermal therapeutic system- nicotine (15 mg/16 h),Nicorette® invisi 15mg patch releasing 15mg of nicotine over 16h, produced by Lohmann Therapie-System, Germany placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy.
C group, (n=20)	Placebo	C group (n=20) (placebo group) each patient received transdermal placebo patch, identical placebo patches custom-made by 1-800-Patches (Salt Lake City, UT) placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy.

Primary Outcome Measures

Name	Time	Method
A Mean Difference of Total Analgesic (Pethidine) Consumption.	[Time Frame: The total pethidine requirements (mg) 12 hours postop]