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

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220615006
Enrollment
105
Registered
2022-06-15
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 Degenerative lumbar spine, 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 Age 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 degenerative lumbar spinal stenosis undergoing operative by pedicular screw instrumentation more than three-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
24-hour morphine consumption 24 hours postoperative reported from PCA—

Secondary

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

Countries

Thailand

Contacts

Public ContactPanya Luksanapruksa

Siriraj hospital

cutecarg@yahoo.com0816638915

Outcome results

None listed

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