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

Phase 2
Completed
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
Registration Number
TCTR20240618002
Lead Sponsor
Research Facilitation Division, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
Brief Summary

The two groups were comparable regarding their characteristics. From 12 hours post-operatively onwards, the nefopam group reported lower VAS pain scores, with significant differences at both 12 hours postoperatively and 16 hours postoperatively. There is a statistically significant overall VAS pain score between groups. Total morphine consumption was significantly lower in the nefopam group during 48 hours postoperatively.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
46
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
pain by visual analog scale 48 hours postoperative visual analog scale
Secondary Outcome Measures
NameTimeMethod
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
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