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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain Relief
• Intervention / Treatment: Drug: Placebo; Drug: transdermal therapeutic system- nicotine.; Drug: transdermal therapeutic system- melatonin.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: C group, (n=20); 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.	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.
Active Comparator: TDN group, (n=20); 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.	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.; Other Names: TDN, Nicorette® invisi 15mg /16hr.
Active Comparator: TDM group, (n=20); 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.	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.; Other Names: TDM, melatonin sleep patch from Respro Labs ™ (7 mg/8hr).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: April 1, 2016
• First Submitted That Met QC Criteria: April 19, 2016
• First Posted (Estimate): April 22, 2016

Study Record Updates

• Last Update Posted (Actual): August 25, 2020
• Last Update Submitted That Met QC Criteria: August 23, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Laparoscopic cholecystectomy; Postoperative pain; Transdermal melatonin; Transdermal nicotine
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Protective Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Antioxidants; Nicotine; Melatonin
• Other Study ID Numbers: 942