Transdermal Nicotine and Melatonin Patches for Postoperative Pain Relief

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain Relief

Treatments: Drug: transdermal therapeutic system- nicotine.; Drug: Placebo; Drug: transdermal therapeutic system- melatonin.

Study type: Interventional

Funder types: Other

Identifiers

NCT02747628

942

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups, including a placebo group

C group, (n=20)

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

TDN group, (n=20)

Active Comparator group

Description:

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.

Treatment:

Drug: transdermal therapeutic system- nicotine.

TDM group, (n=20)

Active Comparator group

Description:

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.

Treatment:

Drug: transdermal therapeutic system- melatonin.