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Comparison of 2 analgesic regimens for pain control after laparoscopic gastrectomy

Dual (Maxigesic: acetaminophen/ibuprofen) versus triple (Maxigesic and nefopam) agent for postoperative analgesia in laparoscopic gastrectomy: a single-center, single-blind, randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009021
Enrollment
128
Registered
2023-12-08
Start date
2024-03-01
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : - Active comparator group (Maxigesic group, group M) Maxigesic 1 ampule (100 ml, 1st dose) & NSS 100 ml (placebo, blinded) administered simultaneously 15 minutes before surgery completion. Sub

Sponsors

Chungnam National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Elective laparoscopic gastrectomy 2. American Society of Anesthesiologists Physical Status Classification 1-3 3. Age range: 20-80 years 4. BMI (Body Mass Index) range: 18.5-35 kg/m2 5. Patients scheduled for the use of patient-controlled analgesia device

Exclusion criteria

Exclusion criteria: 1. Wedge resection 2. Previous non-minor abdominal surgeries (examples of minor surgery: appendectomy, cholecystectomy, hernia repair, etc.) 3. Combined surgery 4. Known allergy or asthma reaction to the study drugs 5. Regular use of narcotic analgesics for more than 3 months before surgery 6. Concurrent use or requirement of analgesics due to ongoing pain 7. Impaired renal function (eGFR < 30 mL/min/1.73 m2) 8. Impaired liver function (cirrhosis, acute hepatitis, preoperative AST or ALT levels greater than 100 [more than twice the normal range]) 9. Pregnancy or breastfeeding 10. Active peptic ulcer disease 11. Closed-angle glaucoma 12. In cases of cognitive impairment and communication limitations making patient-controlled analgesia (PCA) use and pain assessment difficult 13. If planned postoperative pain control does not align with this study (e.g., if a different pain control method such as nerve block is planned)

Design outcomes

Primary

MeasureTime frame
Opioid consumption during postoperative 48 hours

Secondary

MeasureTime frame
Opioid consumption during postoperative 24 hours;Immediate postoperative pain (NRS, post-anesthesia care unit) ;postoperative day 1 morning pain (maximum/ minimum NRS);postoperative day 2 morning pain (maximum/ minimum NRS);postoperative day 1 QOR 15;postoperative day 2 QOR 15;use of rescue antiemetics ;use of rescue analgesics

Countries

Korea, Republic of

Contacts

Public ContactChahyun Oh

Chungnam National University Hospital

5chahyun@naver.com+82-42-280-7840

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026