Transdermal Nicotine and Melatonin Patches for Postoperative Pain Relief

Postoperative Pain Relief Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02747628
• Other study ID #: 942
• Status: Completed
• Phase: Phase 4
• Start date: April 2013
• Est. completion date: July 2015

Study information

• Verified date: August 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain Relief

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A Mean Difference of Total Analgesic (Pethidine) Consumption.		[Time Frame: The total pethidine requirements (mg) 12 hours postop]