The effect of Ultra-low-dose Naloxone combined with Patient-Controlled-Analgesia Intravenous Morphine in Complex Spine Surgery: A Double blinded, Randomized Controlled Trial

Phase 3

• Conditions: Postoperative pain in patients undergoing complex spine surgery; Pain, Postoperative; Laminectomies; Naloxone

• Registration Number: TCTR20221001003
• Lead Sponsor: Faculty of Medicine, Chiang Mai University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Study Completion: 2023-09-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Elective Open complex spine Surgery
2. Age 18-70
3. The American Society of Anesthesiologists (ASA) physical status classification I-III

Exclusion Criteria

1. History of previous spine surgery
2. Hepatic or renal failure
3. Chronic opioid use
4. Allergy or contraindicated to medications used in study protocol
-Refuse to participate or withdraw their consent at any stage of the study
-Inability to understand the VAS or to operate the PCA device

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average pain intensity Within 24 hr post operatively Visual Analogue Scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Total morphine consumption 6,12,24,48 hours postoperatively mg,Pain intensity 0,6,12,24,48 hours postoperatively Visual Analogue Scale (VAS),Side effect of morphine (Nausea&Vomiting , Pruritus, Respiratory depression) required treatment within 24 hr post operatively Patient report,Time to first rehabilitation The day the patient can sit by themselves Patient report,Length of stay in the hospital The day the patient discharge from the hospital Days,Patient satisfaction before discharge from the hospital Patient Global Impression of Change (PGIC) scale