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Intraoperative intravenous nefopam to reduce morphine consumption after total laparoscopic hysterectomy: a prospective triple blinded randomized controlled trial

Intraoperative intravenous nefopam to reduce morphine consumption after total laparoscopic hysterectomy: a prospective triple blinded randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250521006
Enrollment
168
Registered
2025-05-21
Start date
2025-08-04
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

Disease of uterus/ovary Laparoscopic hysterectomy Postoperative opioid consumption Multimodal analgesia Nefopam Nefopam Laparoscopic hysterectomy Postoperative opioid consumption Postoperative pain control

Interventions

Nefopam 20 mg IV drip in 60 minutes at 1 hour before ending operation,NSS 100 ml IV drip in 60 minutes at 1 hour before ending operation
Experimental Drug,Placebo Comparator Other
Nefopam IV drip,NSS IV drip

Sponsors

Faculty of Medicine, Prince of Songkla University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. age 18-65 2. ASA classification 1-3 3. Patients were scheduled for Laparoscopic Hysterectomy 4. Elective surgery

Exclusion criteria

Exclusion criteria: 1. Allergy or Drug Sensitivity to drugs being used in the investigation (paracetamol, bupivacaine, nefopam, dynastat, opioids), sulfonamide 2. Severe cardiovascular diseases (Congestive heart failure NYHAII-IV, post CABG, established ischemic heart disease) 3. Peripheral arterial disease 4. Bleeding disorder, coagulopathy, on anticoagulants (warfarin) 5. Neurological disorders, cerebrovascular disease, history of convulsion 6. Severe hepatic impairment (serum albumin<25g/L, or Child-Pugh score>=10) 7. Severe renal impairment (GFR<30mL/min/1.73m2) 8. Asthma, urticaria, or allergic type reaction after taking aspirin, NSAIDs or other COX-2 specific inhibitors. 9. Angle-closure glaucoma 10. Concomitant use with MAOIs, fluconazole, diuretics, cyclosporine, methotrexate, lithium opioid derivatives (analgesics, anti-cough products and substitutive treatment), neuroleptics, barbiturates, benzodiazepine, anxiolytics other than benzodiazepines, hypnotics, sedative antidepressants (TCAs, SSRIs and SNRI), sedative antihistaminic H1, central antihypertensive drugs, baclofen and thalidomide 11. Who have inflammatory bowel disease, ulcer, bleeding or perforation of gastrointestinal tract 12. Pre-existing chronic pain conditions requiring regular pain medication. 13. Individuals with psychiatric disorders that impair the ability to provide informed consent or comply with study procedures. 14. Pregnancy and Lactation 15. Body mass index >40 kg/m2 16. Concomitant use of tramadol

Design outcomes

Primary

MeasureTime frame
Postoperative morphine consumption 6, 12, 18, 24 PCA morphine

Secondary

MeasureTime frame
Numerical rating scale pain score 6, 12, 18, 24 NRS pain score

Countries

Thailand

Contacts

Public ContactMaliwan Oofuvong

Faculty of Medicine, Prince of Songkla University

oomaliwa@gmail.com074451651

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026