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Analgesic efficacy of nefopam for acute postoperative pain after ankle fracture surgery: triple-blind randomized controlled trial

Analgesic efficacy of nefopam for acute postoperative pain after ankle fracture surgery: triple-blind randomized controlled trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20240618002
Enrollment
46
Registered
2024-06-18
Start date
2021-08-01
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

To reduce morphine use and morphine related side effect for postoperative pain control after ankle fracture fixation Ankle fracture, nefopam, morphine, postoperative pain, ankle fracture fixation

Interventions

Nefopam 20 mg with normal saline solution 98 ml intravenous drip in 1 hour after surgical wound closure then Nefopam 80 mg with normal saline solution 492 ml intravenous drip 20 ml/hr within 24 hours,
Experimental Drug,Placebo Comparator No treatment

Sponsors

Research Facilitation Division, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age 15-70 years old 2. American Society of Anesthesiologists (ASA) physical status) class I, II and III 3. Undergo ankle fracture fixation

Exclusion criteria

Exclusion criteria: 1. Contraindication for nefopam 2. History of allergic to any drugs in study protocol 3. History of opioids use within 3 months 4. Contraindication for spinal anesthesia 5. Peripheral neuropathies 6. Multi-organ injuries 7. Cognitive impairment 8. Pregnancy 9. Refuse to join study

Design outcomes

Primary

MeasureTime frame
pain by visual analog scale 48 hours postoperative visual analog scale

Secondary

MeasureTime frame
morphine consumption 48 hours Total dose of morphine ,Time to first dose of morhpine 0-48 hours Time to first dose of morhpine,side effects of morphine 48 hours side effects of morphine,side effects of nefopam 48 hours side effects of nefopam

Countries

Thailand

Contacts

Public ContactSamrit Tanya

Faculty of Medicine Vajira Hospital, Navamindradhiraj University

samrit@nmu.ac.th022443376

Outcome results

None listed

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