Analgesic Efficacy of Intravenous Nefopam after Spine Surgery

Phase 4

Completed

• Conditions: Patients undergo lumbosacral spine surgery; Nefopam; Postoperative pain; Spine surgery

• Registration Number: TCTR20171115001
• Lead Sponsor: Department of Medical Services

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-15
• Study Completion: 2018-09-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

1. Age ≥ 18 years
2. Scheduled for lumbosarcral spine surgery under general anesthesia
3. ASA physical status I - III
4. Operation time 4 - 6 hours
5. Not known allergy to morphine and nefopam

Exclusion Criteria

1. Current nefopam use within 24 hours prior to study
2. Previous history of cardiovascular disease
3. Previous history of epilepsy
4. Previous history of liver disease
5. Previous history of chronic opioids therapy > 2 weeks
6. Previous history of chronic Monoamine oxidase inhibitors (MAOIs) therapy > 2 weeks
7. Unable to use patient controlled analgesia (PCA) device
8. Creatinine clearance < 30 mL/min (calculated by the Cockcroft-Gault equation)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
analgesic efficacy of nefopam and placebo 24-hour postoperatively morphine consumption (mg)

Secondary Outcome Measures

Name	Time	Method
the safety of nefopam 24-hour postoperatively incidence of tachycardia, sweating, sedation, nausea or vomiting