NCT02726126

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2013

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2016

Completed
Last Updated

April 5, 2016

Status Verified

April 1, 2016

Enrollment Period

2.1 years

First QC Date

March 29, 2016

Last Update Submit

April 3, 2016

Conditions

Postoperative Pain

Keywords

Transdermal fentanylTransdermal melatoninPostoperative painlumber laminectomyRelief

Outcome Measures

Primary Outcomes (1)

  • A mean difference of total analgesic (pethidine) consumption.

    The total pethidine requirements (mg) 12 hours postop

Study Arms (3)

C group, (n=25)

C group, (n=25) each patient received transdermal placebo patch

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

TDF group, (n=25)

TDF group, (n=25) each patient received transdermal therapeutic system-fentanyl 50μg/h

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

TDM group, (n=25)

TDM group, (n=25) each patient received transdermal therapeutic system containing 7 mg of melatonin

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

Interventions

Comparative study between transdermal fentanyl and melatonin patches on postoperative pain relief after lumber laminectomyDRUG
C group, (n=25)TDF group, (n=25)TDM group, (n=25)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

This study was designed to be a randomized, placebo-controlled, double-blind parallel study in which the patients, investigators, anesthesiologists and the surgeons were blinded to the given treatment. This study was conducted in Ain-Shams university hospitals, from March 2013 to April 2015 on 75 patients aged between 18 and 50 years old of both sex of ASA physical status I and II of 70-90 kg body weight and height 160-180 cm undergoing elective single level lumber laminectomy under general anesthesia. The study protocol was approved from the institutional ethical committee and written informed consent was obtained from all the patients.

You may qualify if:

  • patients aged between 18 and 50 years old
  • Both sex of ASA physical status I and II
  • kg body weight
  • Height 160-180 cm
  • Undergoing elective single level lumber laminectomy 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.Ibrahim Mamdouh Esmat

Study Record Dates

First Submitted

March 29, 2016

First Posted

April 1, 2016

Study Start

March 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

April 5, 2016

Record last verified: 2016-04