Stomach NeoplasmsPhase 2NCT07768514
Maxigesic for Postoperative Pain Control After Laparoscopic or Robotic Gastrectomy
A Phase 2 study testing Acetaminophen and Ibuprofen and Acetaminophen in people with Stomach Neoplasms, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- Acetaminophen and Ibuprofen and Acetaminophen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Nov 2025to 25 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongam, Gyeonggi-do, 13620
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Stomach Neoplasms
- Being tested
- Acetaminophen and Ibuprofen, Acetaminophen
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetaminophen and IbuprofenDrug
Also called Maxigesic
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.
AcetaminophenDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Maxigesic Arm | Experimental | 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. Receives: Drug: Acetaminophen and Ibuprofen |
| Acetaminophen Arm | Active comparator | 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. Receives: Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sum of Pain Intensity Differences Over 72 Hours (SPID72)
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).
Measured: From immediately after surgery through 72 hours after surgery
Secondary outcomes (4)
Postoperative Pain Intensity Assessed by Numeric Rating Scale (NRS)
Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS) immediately after surgery and at 12, 24, and 48 hours after surgery.
Measured: Immediately after surgery and at 12, 24, and 48 hours after surgery
Number of Antiemetic Administrations
The number of antiemetic administrations during the first 48 hours after surgery will be recorded and compared between the treatment groups.
Measured: From the end of surgery through 48 hours after surgery
Total Opioid Consumption
Total opioid consumption administered through fentanyl-based patient-controlled analgesia (PCA) during the first 48 hours after surgery will be assessed.
Measured: From the end of surgery through 48 hours after surgery
Number of Rescue Analgesic Administrations
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.
Measured: From the end of surgery through 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start21 Nov 2025
- Primary completion8 Nov 2026 (estimated)
- Study completion25 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- KB Pharma
- Responsible party
- Principal investigator, So Hyun Kang, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768514
- Sponsor's protocol ID
- Maxi
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It may be shared upon request after getting approval from our institution's IRB.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07768514
- Acronym / sponsor ID
- Maxi
- Conditions
- Stomach Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- KB Pharma
- Study start
- 21 Nov 2025 (actual)
- Primary completion
- 8 Nov 2026 (estimated)
- Study completion
- 25 Dec 2026 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maxigesic Arm | Experimental | Drug: Acetaminophen and IbuprofenParticipants 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. |
| Acetaminophen Arm | Active comparator | Drug: AcetaminophenParticipants 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetaminophen and IbuprofenAlso: MaxigesicMaxigesic 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. | Drug | Maxigesic Arm |
| AcetaminophenAcetaminophen 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. | Drug | Acetaminophen Arm |
Primary outcome
Sum of Pain Intensity Differences Over 72 Hours (SPID72)
Time frame: 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).
4 secondary outcomes
Postoperative Pain Intensity Assessed by Numeric Rating Scale (NRS)
Time frame: Immediately after surgery and at 12, 24, and 48 hours after surgery
Number of Antiemetic Administrations
Time frame: From the end of surgery through 48 hours after surgery
Total Opioid Consumption
Time frame: From the end of surgery through 48 hours after surgery
Number of Rescue Analgesic Administrations
Time frame: From the end of surgery through 48 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No. It may be shared upon request after getting approval from our institution's IRB.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acetaminophen and Ibuprofen and Acetaminophen in people with Stomach Neoplasms, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sum of Pain Intensity Differences Over 72 Hours (SPID72) (time frame: From immediately after surgery through 72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026; AzTrials last refreshed its copy on 1 Nov 2026.