Transdermal Nicotine and Melatonin Patches for Postoperative Pain Relief

NCT02747628 | Completed Phase 4 Results

• 1 other identifier: 942
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Postoperative Pain Relief

Keywords

Transdermal nicotine; Transdermal melatonin; Postoperative pain; Laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

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

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

Study Arms (3)

C group, (n=20)

PLACEBO COMPARATOR

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.

Drug: Placebo

TDN group, (n=20)

ACTIVE COMPARATOR

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.

Drug: transdermal therapeutic system- nicotine.

TDM group, (n=20)

ACTIVE COMPARATOR

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.

Drug: transdermal therapeutic system- melatonin.

Interventions

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.

C group, (n=20)

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.

Also known as: TDN, Nicorette® invisi 15mg /16hr.

TDN group, (n=20)

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.

Also known as: TDM, melatonin sleep patch from Respro Labs ™ (7 mg/8hr).

TDM group, (n=20)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• female patients.
• non-smoker patients.
• aged between 18 and 50 years old.
• ASA physical status I and II.
• kg body weight and height 160-180 cm.
• undergoing elective laparoscopic cholecystectomy under general anesthesia.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Ibrahim Mamdouh Esmat
• Organization: Ain-Shams University Hospitals

ibrahim_mamdouh@med.asu.edu.eg

01001241928

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 1, 2016
• First Posted: April 22, 2016
• Study Start: April 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 25, 2020
• Results First Posted: August 20, 2020

Record last verified: 2020-08