Duloxetine as an Analgesic Agent in Patients Undergoing Elective Spine Surgery

NCT02535000 | Completed Phase 4 Results DMC

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

Brief 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.

Conditions

Intervertebral Disc Degeneration

Outcome Measures

Primary Outcomes (1)

• Total Consumption of Fentanyl (in Micrograms) Self-administered by the Patient and Accessed at 24 and 48 Hours After Spine Surgery.

  The main evaluation parameter was the total consumption of fentanyl (in micrograms) self-administered by the patient and accessed at 24 and 48 hours after surgery. At the beginning of the study, Group C (placebo) would have 30 patients and D (duloxetine) would also have 30 patients. However, 1 patient in Group C and 2 patients in Group D were excluded due to the cancellation of the proposed surgery, after the patient had received 60 milligrams of duloxetine. The lower the consumption of fentanyl, the better the analgesic effect of duloxetine.

  up to 2 days.

Secondary Outcomes (1)

• Self Reported Pain Score Range From 0 (no Pain) to 10 (Worst Possible Pain).

  up to 2 days.

Study Arms (2)

Group C (control)

EXPERIMENTAL

subjects who will receive one capsule of placebo before the surgery and being repeated the next day

Drug: Placebo

Group D (duloxetine)

ACTIVE COMPARATOR

subjects who will receive one capsule of duloxetine 60 mg before the surgery and being repeated the next day

Drug: Duloxetine

Interventions

Duloxetine DRUG

duloxetine 60 mg

Also known as: Cymbalta

Group D (duloxetine)

Placebo DRUG

placebo

Also known as: inactive substance

Group C (control)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients allergics to duloxetine, ketoralac or fentanyl, pre-existing history of use of illegal substances or alcohol in an abusive manner and abnormal kidney or liver function tests.

Sponsors & Collaborators

• Serviço de Anestesiologia de Joinville: lead

Related Publications (1)

• Bedin A, Caldart Bedin RA, Vieira JE, Ashmawi HA. Duloxetine as an Analgesic Reduces Opioid Consumption After Spine Surgery: A Randomized, Double-Blind, Controlled Study. Clin J Pain. 2017 Oct;33(10):865-869. doi: 10.1097/AJP.0000000000000471.

  PMID: 28002096 RESULT

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

We used the same dose as previous investigators. We did not evaluate a possible effect of duloxetine on chronic postsurgical pain.

Results Point of Contact

• Title: Antonio Bedin
• Organization: Serviço de Anestesiologia de Joinville

abjoimailbox-ct@yahoo.com

+554734331666

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 23, 2015
• First Posted: August 28, 2015
• Study Start: January 1, 2014
• Primary Completion: October 20, 2015
• Study Completion: October 30, 2015
• Last Updated: October 9, 2020
• Results First Posted: October 9, 2020

Record last verified: 2020-09