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Completed

NCT Number: NCT02747628

Transdermal Nicotine and Melatonin Patches for Postoperative Pain Relief

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.

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Key information

Conditions

Postoperative Pain Relief Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

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.

Drug

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.

transdermal therapeutic system- melatonin.

Drug

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).

Primary outcomes

  1. A Mean Difference of Total Analgesic (Pethidine) Consumption.

    Time frame: [Time Frame: The total pethidine requirements (mg) 12 hours postop]

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 22, 2016
Registry last updated
Aug 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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