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Analgesic efficacy of perioperative dexamethasone when combined with nefopam in NSAIDs-based gynecological surgery: a randomized, double-blind study

Analgesic efficacy of perioperative dexamethasone when combined with nefopam in NSAIDs-based gynecological surgery: a randomized, double-blind study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20201215002
Enrollment
30
Registered
2020-12-15
Start date
2020-08-03
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

Transabdominal hysterectomy is the most common gynecologic surgery. It also associates with moderate to severe postoperative pain. Multimodal analgesia is the best technique for pain control and impro dexamethasone&#44

Interventions

Dexamethasone 10 mg intravenous before the operation for 1 hour. Nefopam 20 mg in normal saline solution 100 ml intravenous infusion in 30 minutes before the shin closure&#44
and continuous infusion 80 mg in normal saline solution 500 ml in 24 hours for the postoperative period.,Nefopam 20 mg in normal saline solution 100 ml intravenous infusion in 30 minutes before skin c
Dexamethasone with Nefopam group,Nefopam group,Dexamethasone group

Sponsors

Faculty of Medicine Ramathibodi Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 65 Years

Inclusion criteria

Inclusion criteria: Female Age 20 -65 years old Undergoing TAH +/- BSO ASA physical status 1 or 2 Elective case

Exclusion criteria

Exclusion criteria: BMI > 35 kg/m2 Underlying disease: liver failure&#44; renal failure&#44; cardiac disease&#44; psychiatric disorder Creatinine clearance < 30 ml/min History of seizure Chronic pain syndrome Allergy to Morphine&#44; Dexamethasone&#44; Nefopam&#44; Parecoxib Inability to understand VNRS and/or control IV&#45;PCA

Design outcomes

Primary

MeasureTime frame
Total dose requirement of morphine via IVPCA in postoperative phase at 24 hour milligram

Secondary

MeasureTime frame
Verbal Numerical Rating Scale (VNRS) at 0&#44; 1&#44; 6&#44; 12&#44; 24 hour Numeric of pain score,adverse effects: nausea and vomiting&#44; dyspepsia&#44; hyperglycemia at 24 hour percentage

Countries

Thailand

Contacts

Public ContactChusak Okascharoen

Ramathibodi Hospital&#44; Mahidol University

raec.mahidol@gmail.com6622011000

Outcome results

None listed

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