Clinical trial · Interventional
Maxigesic for Postoperative Pain Control After Laparoscopic or Robotic Gastrectomy
Prospective Randomized Trial to Evaluate the Efficacy and Safety of Maxigesic Injection for Post-operative Pain Control in Patients Who Have Undergone Laparoscopic or Robotic Gastrectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This prospective, randomized, phase 4 clinical trial aims to evaluate the efficacy and safety of intravenous Maxigesic, a fixed-dose combination of acetaminophen and ibuprofen, for postoperative pain control in patients undergoing laparoscopic or robotic gastrectomy for gastric cancer. A total of 90 participants will be randomly assigned to receive either Maxigesic or intravenous acetaminophen. The primary objective is to compare postoperative pain control between the two groups using the sum of pain intensity differences over 72 hours (SPID72). Secondary outcomes include postoperative pain scores, opioid consumption, rescue analgesic use, antiemetic use, and safety outcomes.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acetaminophen | Drug | — | UNRESOLVED |
| Acetaminophen and Ibuprofen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Maxigesic Arm
- description
- Participants receive intravenous Maxigesic (acetaminophen 1,000 mg/ibuprofen 300 mg in 100 mL) beginning at the initiation of anesthesia and subsequently at 6-hour intervals during the postoperative treatment period through 72 hours, according to the study protocol. Postoperative fentanyl-based patient-controlled analgesia (PCA) is also provided.
- interventionNames
- Drug: Acetaminophen and Ibuprofen
- type
- ACTIVE_COMPARATOR
- label
- Acetaminophen Arm
- description
- Participants receive intravenous acetaminophen 1,000 mg every 6 hours, four times daily, from postoperative day 0 through postoperative day 2, with a maximum daily dose of 4,000 mg. Postoperative fentanyl-based patient-controlled analgesia (PCA) is also provided.
- interventionNames
- Drug: Acetaminophen
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Adults aged 19 years or older at the time of written informed consent. * Patients scheduled to undergo laparoscopic or robotic gastrectomy for gastric cancer. * American Society of Anesthesiologists (ASA) physical status class I to III. * Patients who voluntarily decide to participate after receiving a detailed explanation of the study and provide written informed consent. Exclusion Criteria: * Patients who do not undergo laparoscopic or robotic gastrectomy. * Patients who require conversion to open surgery. * Known hypersensitivity to any component of the study medications. * Any contraindication to the use of the study medications according to the prescribing information. * Women who are pregnant or breastfeeding, or who plan to become pregnant during the study period. * Participants or their partners who do not agree to use a medically acceptable method of contraception during the study period.
References
Publications (0)
Data not yet available