Transdermal Nicotine and Melatonin Patches for Postoperative Pain Relief

A

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

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.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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