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

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

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20221001003
Enrollment
34
Registered
2022-10-01
Start date
2022-10-03
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain in patients undergoing complex spine surgery Pain, Postoperative Laminectomies Naloxone

Interventions

NSS 500 ml + naloxone total dose 0.25mcg/kg/hr IV 21mL/hr,NSS 500 ml IV 21mL/hr
Active Comparator Drug,Placebo Comparator No treatment
Naloxone (N),Placebo (C)

Sponsors

Faculty of Medicine, Chiang Mai University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Average pain intensity Within 24 hr post operatively Visual Analogue Scale (VAS)

Secondary

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactIsarapong Pianngarn

Faculty of Medicine, Chiang Mai University

isarapong.pn@gmail.com053935522

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026