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The effect of nefopam in prevention of postoperative catheter-related bladder discomfort in patients undergoing laparoscopic gynecologic surgery: randomized controlled Trial

The effect of nefopam in prevention of postoperative catheter-related bladder discomfort in patients undergoing laparoscopic gynecologic surgery: randomized controlled Trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260624008
Enrollment
140
Registered
2026-06-24
Start date
2024-03-05
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

bladder discomfort catheter-related bladder discomfort (CRBD)

Interventions

intravenous nefopam 20 mg diluted in 100 mL normal saline,100 mL normal saline alone
Experimental Drug,Placebo Comparator Drug
N group,C group

Sponsors

Ratchadapisek Research Funds
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Female patients aged 18-80 years 2. American Society of Anesthesiologists physical status I-III 3. Scheduled for elective laparoscopic gynecologic surgery requiring urinary catheterization for at least 24 hours

Exclusion criteria

Exclusion criteria: 1. bladder outflow obstruction or overactive bladder 2. epilepsy or seizure disorders 3. severe cardiovascular, hepatic, or renal disease 4. current use of selective serotonin reuptake inhibitors, monoamine oxidase inhibitors, or tricyclic antidepressants 5. pregnancy or lactation 7. closed-angle glaucoma

Design outcomes

Primary

MeasureTime frame
the incidence of CRBD upon admission to the post-anesthesia care unit (PACU) upon PACU admission incidence of CRBD

Secondary

MeasureTime frame
CRBD incidence at 1, 2, 6, and 24 hours at 1, 2, 6, and 24 hours postoperatively incidence of CRBD,postoperative pain scores at 1, 2, 6, and 24 hours postoperatively NRS,24-hour morphine consumption 24 hours postoperatively morphine accumulative dose

Countries

Thailand

Contacts

Public ContactNalin Chokengarmwong

King Chulalongkorn Memorial Hospital

nalinanes@gmail.com022564000

Outcome results

None listed

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