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 2Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250419002

Enrollment

Registered

2025-04-19

Start date

2023-02-15

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

Elective open complex spine surgery Age 18-70 years old The American Society of Anesthesiologists (ASA) physical status classification I-III Naloxone, IV-PCA, Complex spine surgery

Interventions

For each intervention group will recieved NSS 500 ml + Naloxone total dose 0.25 mcg/kg/hr IV drip rate 21 ml/hr via infusion pump in first 24 hr and IV-PCA at post-anesthesia care unit (PACU).,For eac

Placebo Comparator Drug,Placebo Comparator Drug

Group N,Group C

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Elective open complex spine surgery, 2. Age 18-70 years old, 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, 5. Refuse to participate or withdraw their consent at any stage of the study, 6. Inablity to understand the VAS or to operate the PCA device.

Design outcomes

Primary

Measure	Time frame
Average pain intensity within 24 hr until 24 hours postoperatively Visual Analogue Scale (VAS)	—

Secondary

Measure	Time frame
1. Total morphrine consumption at 6,12,24,48 hours postoperatively total miligrams of morphine consumption,2. Pain intensity (VAS) at 0,6,12,24,48 hours postoperatively Visual Analogue Scale (VAS),3. Side effect of morphine until 48 hours postoperatively (Nausea-vomitting/ Pruritus, Respiratory depression) required treatment,4. Time to first rehabilitation the first day that patient initiation of rehabilitation after the surgery days after the surgery that patient initiation to rehabilitation,5. Length of stay in the hospital the duration of a single episode of hospitalization. days in hospitalization,6. Patient satisfication as Patient Global Impression of Change (PGIC) scale before discharge from the hospital before discharge from the hospital Patient satisfication as Patient Global Impression of Change (PGIC) scale	—

Measure

Time frame

1. Total morphrine consumption at 6,12,24,48 hours postoperatively total miligrams of morphine consumption,2. Pain intensity (VAS) at 0,6,12,24,48 hours postoperatively Visual Analogue Scale (VAS),3. Side effect of morphine until 48 hours postoperatively (Nausea-vomitting/ Pruritus, Respiratory depression) required treatment,4. Time to first rehabilitation the first day that patient initiation of rehabilitation after the surgery days after the surgery that patient initiation to rehabilitation,5. Length of stay in the hospital the duration of a single episode of hospitalization. days in hospitalization,6. Patient satisfication as Patient Global Impression of Change (PGIC) scale before discharge from the hospital before discharge from the hospital Patient satisfication as Patient Global Impression of Change (PGIC) scale

—

Countries

Thailand

Contacts

Public ContactApinya Thipsunate

Faculty of Medicine, Chiangmai University

apinya.thbn@gmail.com0935755445

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026