Overview

This trial is active, not recruiting.

Condition intervertebral disc degeneration
Treatments duloxetine, placebo
Phase phase 4
Sponsor Serviço de Anestesiologia de Joinville
Start date January 2014
End date October 2016
Trial size 60 participants
Trial identifier NCT02535000, 1

Summary

Duloxetine as an analgesic agent in patients undergoing elective spine surgery: evaluation with fentanyl demand controlled by the patient. The primary objective is to evaluate the efficacy of duloxetine in fentanyl consumption during the postoperative period of patients undergoing elective spine surgery by intervertebral disc degeneration . Secondary endpoints were pain scores and the presence or absence of adverse effects such as headache, nausea, vomiting, itching, dizziness and drowsiness.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose supportive care
Arm
(Experimental)
subjects who will receive one capsule of placebo before the surgery and being repeated the next day
placebo inactive substance
placebo
(Active Comparator)
subjects who will receive one capsule of duloxetine 60 mg before the surgery and being repeated the next day
duloxetine Cymbalta
duloxetine 60 mg

Primary Outcomes

Measure
Fentanyl consumption.
time frame: 2 days.

Secondary Outcomes

Measure
Pain intensity.
time frame: 2 days.

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Patients were included, of both genders, aged between 18 and 70 years and American Society of Anesthesiologists (ASA) physical status 1-3 and were eligible for the study Exclusion Criteria: - Patients allergics to duloxetine, or cetoralac to fentanyl, pre-existing history of use of illegal substances or alcohol in an abusive manner and abnormal kidney or liver function tests.

Additional Information

Official title Duloxetine as an Analgesic Agent in Patients Undergoing Elective Spine Surgery
Description Multimodal analgesia is widely advocated for the control of perioperative pain in an attempt to reduce the use of opioids and their side effects. Duloxetine is a selective inhibitor of serotonin and norepinephrine reuptake with demonstrated efficacy in chronic pain such as painful diabetic neuropathy and postherpetic neuralgia. The primary objective is to evaluate the efficacy of duloxetine in fentanyl consumption during the postoperative period of patients undergoing elective spine surgery by intervertebral disc degeneration . Duloxetine as an analgesic agent in patients undergoing elective spine surgery: evaluation with fentanyl demand controlled by the patient. The primary objective is to evaluate the efficacy of duloxetine in fentanyl consumption during the postoperative period of patients undergoing elective spine surgery by degenerative disc disease. Secondary endpoints were pain scores and the presence or absence of adverse effects such as headache, nausea, vomiting, itching, dizziness and drowsiness.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Serviço de Anestesiologia de Joinville.