Transdermal Nicotine and Melatonin Patches for Postoperative Pain Relief

Study Overview
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Brief Summary
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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.

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

Conditions
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Postoperative Pain Relief

Intervention / Treatment
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* Drug: Placebo
* Drug: transdermal therapeutic system- nicotine.
* Drug: transdermal therapeutic system- melatonin.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transdermal nicotine, Transdermal melatonin, Postoperative pain, Laparoscopic cholecystectomy