Duloxetine as an Analgesic Agent in Patients Undergoing Elective Spine Surgery

NCT ID: NCT02535000

Last Updated: 2020-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2015-10-30

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.

Detailed 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.

Conditions

Intervertebral Disc Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Group C (control)

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

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

placebo

Group D (duloxetine)

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

Group Type: ACTIVE_COMPARATOR

Duloxetine

Intervention Type: DRUG

duloxetine 60 mg

Interventions

Duloxetine

duloxetine 60 mg

Intervention Type: DRUG

Placebo

placebo

Intervention Type: DRUG

Other Intervention Names

Cymbalta; inactive substance

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Serviço de Anestesiologia de Joinville

OTHER

Sponsor Role: lead

Responsible Party

antonio bedin

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: RESULT

PMID: 28002096 (View on PubMed)

Other Identifiers

1

Identifier Type: -

Identifier Source: org_study_id