Transdermal Fentanyl and Melatonin Patches for Postoperative Pain Relief

Postoperative Pain Clinical Trial

Official title:

Comparative Study Between Transdermal Fentanyl and Melatonin Patches on Postoperative Pain Relief After Lumber Laminectomy, a Double-blind, Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02726126
• Other study ID #: 915
• Status: Completed
• Phase: N/A
• First received: March 29, 2016
• Last updated: April 3, 2016
• Start date: March 2013
• Est. completion date: April 2015

Study information

• Verified date: April 2016
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Seventy five patients, aged 18-50 years, ASA I and II undergoing elective single level lumber laminectomy under general anesthesia were included in this randomized controlled double-blind study. Patients were randomly divided into 3 groups 25 each, C group patients received transdermal placebo patch, TDF group (50μg/h) and TDM group (7 mg). 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) postoperatively were also assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 75 patients aged between 18 and 50 years old

• Both sex of ASA physical status I and II

• 70-90 kg body weight

• Height 160-180 cm

• Undergoing elective single level lumber laminectomy under general anesthesia.

Exclusion Criteria:

• Patients with impaired kidney or liver functions

• History of cardiac or central nervous system disease

• 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 or allergy to the used medications

• Coagulation defect

• Local infection at the site of application of transdermal patch

• Patient refusal or duration of surgery more than 120 minutes were excluded from the study.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Comparative study between transdermal fentanyl and melatonin patches on postoperative pain relief after lumber laminectomy

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.		The total pethidine requirements (mg) 12 hours postop	Yes