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The analgesic effect of postoperative continuous intravenous Nefopam on acute postoperative pain after decompressive laminectomy and fusion in multi-level spinal metastases: A prospective randomized, double-blind, placebo-controlled trial

The analgesic effect of postoperative continuous intravenous Nefopam on acute postoperative pain after decompressive laminectomy and fusion in multi-level spinal metastases: A prospective randomized, double-blind, placebo-controlled trial

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220616001
Enrollment
105
Registered
2022-06-16
Start date
2022-07-01
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

Pain after multilevel lumbar spine surgery Spinal metastasis, Nefopam, post-operative pain, analgesia

Interventions

1. NSS 500 ml. 2. 0.5% Bupivacaine 20 ml. with Ketorolac 30 mg.,1. NSS 500 ml. 2. 0.5% Bupivacaine 20 ml. with Ketorolac 30 mg. 3. Nefopam 80 mg. if aged over 65 yrs. Nefopam 40 mg.
Active Comparator Drug,Active Comparator Drug
group 1,group 2

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. had been diagnosed with Spinal metastases undergoing operative by pedicular screw instrumentation more than five-level at Siriraj Hospital 2. Aged over 18 years

Exclusion criteria

Exclusion criteria: 1. History of drug allergy to opioids, gabapentinoid, ketorolac or bupivacaine 2. Estimated glomerular filtration rate <30 ml/min 3. Patients with history of epilepsy

Design outcomes

Primary

MeasureTime frame
determine 24-hour morphine consumption 24 hrs. after operative PCA record

Secondary

MeasureTime frame
First time to first IV analgesic after operative report in minute after anesthesia,Mean pain score on 12,24,36,48-hour after operative Visual Analog Scale,Nausea and vomiting on 12,24,36,48-hour postoperative Subjective Examination,Tachycardia 100 times/min on 12,24,36,48-hour postoperative Blood pressure monitor,Side effects of opioids such as Hypotension, Respiratory depression on 12,24,36,48-hour postoperative Blood pressure monitor,Morphine consumption from PCA (Report in the milligram of morphine consumption) on 12,24,36,48 hour postoperative PCA

Countries

Thailand

Contacts

Public ContactSirichai Wilartratsami

Siriraj hospital

Sirichai_W@hotmail.com0813721107

Outcome results

None listed

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