Stomach Neoplasms
Conditions
Brief summary
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.
Detailed description
Postoperative pain management is an important component of recovery after gastrectomy. Opioids are commonly used for the treatment of acute postoperative pain; however, opioid-related adverse effects and concerns regarding excessive opioid exposure have increased interest in multimodal analgesic strategies that combine non-opioid analgesics. Maxigesic is an intravenous fixed-dose combination of acetaminophen 1,000 mg and ibuprofen 300 mg. This study is designed to evaluate whether perioperative administration of Maxigesic provides effective postoperative analgesia and reduces the need for opioid and rescue analgesics compared with intravenous acetaminophen alone in patients undergoing minimally invasive gastrectomy for gastric cancer. A total of 90 adult participants scheduled to undergo laparoscopic or robotic gastrectomy will be randomly assigned in a 1:1 ratio to the Maxigesic group or the acetaminophen control group. Participants assigned to the Maxigesic group will receive intravenous Maxigesic at the initiation of anesthesia and subsequently at 6-hour intervals after surgery through 72 hours after surgery. Participants assigned to the control group will receive intravenous acetaminophen 1,000 mg at 6-hour intervals according to the postoperative analgesic protocol. Postoperative patient-controlled analgesia containing fentanyl will be available, and additional rescue analgesics may be administered as clinically indicated. Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS) immediately after surgery and at 12, 24, 48, and 72 hours after surgery. The primary efficacy outcome is the sum of pain intensity differences over the first 72 postoperative hours (SPID72). Secondary efficacy outcomes include NRS pain scores at predefined postoperative time points, total opioid consumption during the first 48 hours, the number of rescue analgesic administrations during the first 48 hours, and the use of antiemetic medications during the first 48 hours. Safety will be evaluated through the assessment of adverse events until postoperative day 5 or hospital discharge.
Interventions
Maxigesic is a fixed-dose combination containing acetaminophen 1,000 mg and ibuprofen 300 mg in 100 mL. One vial is administered intravenously over 15 minutes at the initiation of anesthesia, followed by administration at 6-hour intervals during the postoperative treatment period through 72 hours after surgery.
DRUGAcetaminophen
Acetaminophen 1,000 mg is administered intravenously over 15 minutes every 6 hours, four times daily, from postoperative day 0 through postoperative day 2. The maximum daily dose does not exceed 4,000 mg.
Sponsors
Seoul National University Bundang Hospital
KB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sum of Pain Intensity Differences Over 72 Hours (SPID72) | From immediately after surgery through 72 hours after surgery | Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS) immediately after surgery and at 12, 24, 48, and 72 hours after surgery. The primary outcome is the sum of pain intensity differences over the first 72 postoperative hours (SPID72). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity Assessed by Numeric Rating Scale (NRS) | Immediately after surgery and at 12, 24, and 48 hours after surgery | Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS) immediately after surgery and at 12, 24, and 48 hours after surgery. |
| Number of Antiemetic Administrations | From the end of surgery through 48 hours after surgery | The number of antiemetic administrations during the first 48 hours after surgery will be recorded and compared between the treatment groups. |
| Total Opioid Consumption | From the end of surgery through 48 hours after surgery | Total opioid consumption administered through fentanyl-based patient-controlled analgesia (PCA) during the first 48 hours after surgery will be assessed. |
| Number of Rescue Analgesic Administrations | From the end of surgery through 48 hours after surgery | The total number of rescue analgesic administrations, including tramadol or pethidine, during the first 48 hours after surgery will be recorded. Rescue analgesics may be administered when the NRS pain score is 4 or higher. |
Countries
South Korea
Outcome results
None listed