Transdermal Nicotine and Melatonin Patches for Postoperative Pain Relief
Condition: Postoperative Pain Relief
MeSH terms: Pain, Postoperative
Intervention: Placebo; transdermal therapeutic system- nicotine.; transdermal therapeutic system- melatonin.
Intervention description: 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.; 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.; 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.
Intervention MeSH terms: Melatonin; Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 60.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Transdermal nicotine; Transdermal melatonin; Postoperative pain; Laparoscopic cholecystectomy

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.
    

Eligibility criteria:

        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.