Stomach NeoplasmsPhase 4NCT07687394
A Phase IV Randomized Trial of Maxigesic® Versus Standard Analgesia After Radical Gastrectomy
A Phase 4 study testing Acetaminophen (Newaminophen Premix) and Maxigesic IV (acetaminophen/ibuprofen) in people with Stomach Neoplasms and Pain, run by Yonsei University.
Trial summary
Background: Radical gastrectomy causes moderate-to-severe pain during the first 48 hours after surgery. Opioids are effective but carry adverse effects and risks of prolonged use, so ERAS-based care recommends multimodal analgesia. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stomach Neoplasms, Pain, Postoperative
- What is being tested?
- Acetaminophen (Newaminophen Premix) and Maxigesic IV (acetaminophen/ibuprofen)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 31 Dec 2028
- Phase
- Phase 4
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 20 to 80 years diagnosed with gastric cancer by endoscopic biopsy who are scheduled for minimally invasive radical gastrectomy (laparoscopic or robotic)
- Patients scheduled for distal, proximal, or total gastrectomy among minimally invasive procedures (wedge resection, pylorus-preserving gastrectomy, and segmental gastrectomy are not eligible)
- Patients with an ECOG performance status of 0 or 1 and an ASA classification of I-III
- Patients who have voluntarily agreed to participate after receiving a full explanation of the study's purpose and content, and who have signed the written informed consent form approved by the Institutional Review Board
- Patients residing in Korea who are able to complete follow-up for 3 months after surgery
Who cannot join
- Patients with a reported history of hypersensitivity, allergy, or adverse reaction to NSAIDs, opioids, or acetaminophen
- Patients currently taking medications that may affect the study results, such as opioid or non-opioid analgesics, aspirin, warfarin or other anticoagulants, steroids, or high-dose hepatotoxic drugs
- Pregnant or breastfeeding patients
- Patients with a contraindication to NSAIDs or acetaminophen identified from medical history or preoperative evaluation-for example, active liver disease, heart failure, chronic kidney disease, thrombocytopenia, or a history of asthma (peptic ulcer disease is not an exclusion criterion)
- Patients unable to read or understand the informed consent form
- Patients weighing less than 45 kg
- Patients scheduled for transfer to the intensive care unit instead of a general ward after surgery (ICU preparation)
- Patients scheduled for emergency surgery
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase IV, Multicenter, Double-blind, Randomized Controlled Trial to Evaluate the Superiority of Maxigesic® Over Standard Analgesia in Patients Undergoing Radical Gastrectomy
Background: Radical gastrectomy causes moderate-to-severe pain during the first 48 hours after surgery. Opioids are effective but carry adverse effects and risks of prolonged use, so ERAS-based care recommends multimodal analgesia. Acetaminophen is the most commonly used non-opioid analgesic in gastrectomy patients; adding ibuprofen as a fixed-dose combination has shown improved analgesia and opioid-sparing effects compared with acetaminophen alone in other surgical populations, but direct evidence in gastrectomy patients is limited.
Objective: To evaluate whether scheduled administration of an acetaminophen-ibuprofen fixed-dose combination (Maxigesic® IV) is superior to acetaminophen alone for pain relief after radical gastrectomy, with exploratory assessment of cost-effectiveness and of differences in analgesic efficacy according to genetic polymorphisms.
Read more
Hypothesis: When given on an identical scheduled regimen, the acetaminophen-ibuprofen fixed-dose combination produces significantly lower pain scores (NRS) over the first 48 postoperative hours than acetaminophen alone (superiority).
Study plan: This is a phase IV, multicenter, double-blind, randomized controlled trial in which 160 gastric cancer patients scheduled for minimally invasive radical gastrectomy (80 per arm) are randomized 1:1 with stratification by institution. In both arms, the assigned drug is given as a 15-minute intravenous infusion every 6 hours, starting 30 minutes before the end of surgery through 48 hours postoperatively. The primary endpoint is the between-group difference in the time-weighted average (TWA) of repeatedly measured resting and active NRS over 48 hours, analyzed using a mixed model for repeated measures (MMRM); secondary endpoints include opioid consumption (MME), the Quality of Recovery score (QoR-15K), the incidence of chronic postsurgical pain (CPSP), and in-hospital costs.
Read the detailed description
This is a phase IV, multicenter, double-blind, randomized controlled trial conducted at four Yonsei University-affiliated hospitals in the Republic of Korea (Severance, Gangnam Severance, Wonju Severance, and Yongin Severance Hospitals). A total of 160 patients with gastric cancer scheduled for minimally invasive (laparoscopic or robotic) radical gastrectomy are randomized 1:1 to the experimental arm (acetaminophen-ibuprofen fixed-dose combination, Maxigesic IV) or the active comparator arm (acetaminophen alone, Newaminophen Premix). Randomization uses a stratified block design with the participating institution as the stratification factor, and allocation is concealed through a web-based system using a sequence generated by an independent statistician.
To maintain double blinding, study drugs are prepared by an unblinded research pharmacist in a separate area and dispensed in containers masked with opaque labels, so that participants, care providers, and outcome assessors remain unaware of the allocation.
In both arms, the assigned study drug is administered as a 15-minute intravenous infusion every 6 hours, beginning 30 minutes before the end of surgery and continuing through 48 hours after surgery (9 doses in total), with the total daily acetaminophen dose not exceeding 4 g. For breakthrough pain, a standardized stepwise rescue protocol (tramadol followed by pethidine) is applied without altering the scheduled study-drug regimen, and fever requiring an antipyretic is managed with ibuprofen. The two arms are identical except for the addition of ibuprofen in the experimental arm.
Pain intensity is assessed using the 11-point Numerical Rating Scale at rest and on movement at predefined time points over the first 72 hours after surgery. Additional assessments include opioid consumption (morphine milligram equivalents), the Korean Quality of Recovery score (QoR-15K), in-hospital costs, and chronic postsurgical pain at 3 months measured with the Brief Pain Inventory-Korean (BPI-K). Safety is evaluated by postoperative complications (Clavien-Dindo classification), adverse drug reactions, and liver enzyme elevation.
As exploratory analyses, an economic evaluation and a pharmacogenomic analysis are performed. No biospecimen is collected in this study. The pharmacogenomic analysis is conducted only in the subset of participants who are also enrolled in the National Bio Big Data Project, a separate national genomic study; for these participants, whole-genome sequencing data generated by that project are used-under that project's own consent and governance framework-to explore whether genetic polymorphisms are associated with differences in analgesic efficacy.
The primary efficacy analysis is performed in the full analysis set, with the per-protocol set used for sensitivity analysis. The treatment effect on the primary outcome is evaluated as the between-group difference in the time-weighted average of NRS over 0-48 hours, estimated using a mixed model for repeated measures, with a covariate-adjusted linear mixed model as a supportive analysis. A Data Safety Monitoring Board reviews safety and data validity, and an interim analysis for safety and futility is conducted when 50% of the target participants have completed 72-hour follow-up. A two-sided significance level of 0.05 is applied.
- Conditions
- Stomach Neoplasms, Pain, Postoperative
- Being tested
- Acetaminophen (Newaminophen Premix), Maxigesic IV (acetaminophen/ibuprofen)
- Keywords
- Gastrectomy
- Medical subject headings
- Stomach Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetaminophen (Newaminophen Premix)Drug
As an active comparator, Newaminophen Premix 100 mL will be administered by 15-minute intravenous infusion every 6 hours during the first 48 hours after surgery.
Maxigesic IV (acetaminophen/ibuprofen)Drug
Maxigesic 100 mL will be administered as a 15-minute intravenous infusion every 6 hours for the first 48 hours after surgery
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen | Active comparator | Participants receive acetaminophen alone (Newaminophen Premix, acetaminophen 1000 mg per 100 mL) as a 15-minute intravenous infusion every 6 hours, starting 30 minutes before the end of surgery and continuing through 48 hours after surgery (9 doses in total). The total daily acetaminophen dose does not exceed 4 g. Receives: Drug: Acetaminophen (Newaminophen Premix) |
| Maxigesic | Experimental | Participants receive the acetaminophen-ibuprofen fixed-dose combination (Maxigesic IV, acetaminophen 1000 mg + ibuprofen 300 mg per 100 mL) on the same schedule as the comparator arm: a 15-minute intravenous infusion every 6 hours, starting 30 minutes before the end of surgery and continuing through 48 hours after surgery (9 doses in total). The total daily acetaminophen dose does not exceed 4 g. Receives: Drug: Maxigesic IV (acetaminophen/ibuprofen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity (NRS)
The primary endpoint is the between-group difference in postoperative pain intensity, measured with the 11-point Numerical Rating Scale (NRS; 0 = no pain, 10 = worst pain imaginable). Pain is assessed both at rest and on movement and is measured repeatedly over the first 48 hours after surgery (at rest from 0 to 48 hours; on movement from 6 to 48 hours). The treatment effect is evaluated as the between-group difference in the time-weighted average (TWA) of NRS over 0-48 hours, estimated using a mixed model for repeated measures (MMRM). A linear mixed model adjusting for covariates (e.g., extent of gastric resection) is performed as a supportive analysis to confirm the consistency of the results.
Measured: At rest - 0 (immediately postoperatively), 2, 4, 6, 12, 18, 24, 30, 36, 42, and 48 hours after surgery; on movement - 6, 12, 18, 24, 30, 36, 42, and 48 hours after surgery
Secondary outcomes (5)
Total opioid consumption
Total opioid consumption through 72 hours after surgery, expressed as morphine milligram equivalents (MME)
Measured: From the day of operation (day 0) to 72 hours after surgery
Change in Quality of Recovery (QoR-15K)
Change in the Korean version of the 15-item Quality of Recovery questionnaire (QoR-15K) from baseline.
Measured: Preoperative, 24 hours aftery surgery, 48 hours after surgery, 72 hours after surgery
Incidence of chronic postsurgical pain (CPSP)
Proportion of patients with chronic postsurgical pain, assessed using the Brief Pain Inventory-Korean (BPI-K).
Measured: At 3 months after surgery (±14 days)
(exploratory analysis) In-hospital cost
Total medical costs incurred during the hospital stay, compared between groups.
Measured: Through discharge, an average of 5 days
(exploratory analysis) Difference in analgesic efficacy according to genetic polymorphisms
NRS scores of the experimental group accordnig to CYP gene polymorphism. Exploratory analysis, performed only in participants who are co-enrolled in the National Bio Big Data Project.
Measured: Genetic polymorphism assessed preoperatively. NRS scores measured through 72 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 posted7 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion31 Dec 2028 (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.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687394
- Sponsor's protocol ID
- 4-2026-0528
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results (primary and secondary clinical outcomes) will be made available to qualified researchers whose proposal is approved by the principal investigator and the Institutional Review Board. Data will be available beginning 12 months after publication of the main results, with no specified end date, under a signed data-use agreement. The study protocol and statistical analysis plan may also be shared on request. Genomic (whole-genome sequencing) data will not be shared owing to re-identification risk and consent and regulatory constraints.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Multicenter, Double-blind, Randomized Controlled Trial to Evaluate the Superiority of Maxigesic® Over Standard Analgesia in Patients Undergoing Radical Gastrectomy
- ClinicalTrials.gov ID
- NCT07687394
- Acronym / sponsor ID
- 4-2026-0528
- Conditions
- Stomach Neoplasms, Pain, Postoperative
- Keywords
- Gastrectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 Jul 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.
Background: Radical gastrectomy causes moderate-to-severe pain during the first 48 hours after surgery. Opioids are effective but carry adverse effects and risks of prolonged use, so ERAS-based care recommends multimodal analgesia. Acetaminophen is the most commonly used non-opioid analgesic in gastrectomy patients; adding ibuprofen as a fixed-dose combination has shown improved analgesia and opioid-sparing effects compared with acetaminophen alone in other surgical populations, but direct evidence in gastrectomy patients is limited.
Objective: To evaluate whether scheduled administration of an acetaminophen-ibuprofen fixed-dose combination (Maxigesic® IV) is superior to acetaminophen alone for pain relief after radical gastrectomy, with exploratory assessment of cost-effectiveness and of differences in analgesic efficacy according to genetic polymorphisms.
Hypothesis: When given on an identical scheduled regimen, the acetaminophen-ibuprofen fixed-dose combination produces significantly lower pain scores (NRS) over the first 48 postoperative hours than acetaminophen alone (superiority).
Study plan: This is a phase IV, multicenter, double-blind, randomized controlled trial in which 160 gastric cancer patients scheduled for minimally invasive radical gastrectomy (80 per arm) are randomized 1:1 with stratification by institution. In both arms, the assigned drug is given as a 15-minute intravenous infusion every 6 hours, starting 30 minutes before the end of surgery through 48 hours postoperatively. The primary endpoint is the between-group difference in the time-weighted average (TWA) of repeatedly measured resting and active NRS over 48 hours, analyzed using a mixed model for repeated measures (MMRM); secondary endpoints include opioid consumption (MME), the Quality of Recovery score (QoR-15K), the incidence of chronic postsurgical pain (CPSP), and in-hospital costs.
Detailed description
This is a phase IV, multicenter, double-blind, randomized controlled trial conducted at four Yonsei University-affiliated hospitals in the Republic of Korea (Severance, Gangnam Severance, Wonju Severance, and Yongin Severance Hospitals). A total of 160 patients with gastric cancer scheduled for minimally invasive (laparoscopic or robotic) radical gastrectomy are randomized 1:1 to the experimental arm (acetaminophen-ibuprofen fixed-dose combination, Maxigesic IV) or the active comparator arm (acetaminophen alone, Newaminophen Premix). Randomization uses a stratified block design with the participating institution as the stratification factor, and allocation is concealed through a web-based system using a sequence generated by an independent statistician.
To maintain double blinding, study drugs are prepared by an unblinded research pharmacist in a separate area and dispensed in containers masked with opaque labels, so that participants, care providers, and outcome assessors remain unaware of the allocation.
In both arms, the assigned study drug is administered as a 15-minute intravenous infusion every 6 hours, beginning 30 minutes before the end of surgery and continuing through 48 hours after surgery (9 doses in total), with the total daily acetaminophen dose not exceeding 4 g. For breakthrough pain, a standardized stepwise rescue protocol (tramadol followed by pethidine) is applied without altering the scheduled study-drug regimen, and fever requiring an antipyretic is managed with ibuprofen. The two arms are identical except for the addition of ibuprofen in the experimental arm.
Pain intensity is assessed using the 11-point Numerical Rating Scale at rest and on movement at predefined time points over the first 72 hours after surgery. Additional assessments include opioid consumption (morphine milligram equivalents), the Korean Quality of Recovery score (QoR-15K), in-hospital costs, and chronic postsurgical pain at 3 months measured with the Brief Pain Inventory-Korean (BPI-K). Safety is evaluated by postoperative complications (Clavien-Dindo classification), adverse drug reactions, and liver enzyme elevation.
As exploratory analyses, an economic evaluation and a pharmacogenomic analysis are performed. No biospecimen is collected in this study. The pharmacogenomic analysis is conducted only in the subset of participants who are also enrolled in the National Bio Big Data Project, a separate national genomic study; for these participants, whole-genome sequencing data generated by that project are used-under that project's own consent and governance framework-to explore whether genetic polymorphisms are associated with differences in analgesic efficacy.
The primary efficacy analysis is performed in the full analysis set, with the per-protocol set used for sensitivity analysis. The treatment effect on the primary outcome is evaluated as the between-group difference in the time-weighted average of NRS over 0-48 hours, estimated using a mixed model for repeated measures, with a covariate-adjusted linear mixed model as a supportive analysis. A Data Safety Monitoring Board reviews safety and data validity, and an interim analysis for safety and futility is conducted when 50% of the target participants have completed 72-hour follow-up. A two-sided significance level of 0.05 is applied.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen | Active comparator | Drug: Acetaminophen (Newaminophen Premix)Participants receive acetaminophen alone (Newaminophen Premix, acetaminophen 1000 mg per 100 mL) as a 15-minute intravenous infusion every 6 hours, starting 30 minutes before the end of surgery and continuing through 48 hours after surgery (9 doses in total). The total daily acetaminophen dose does not exceed 4 g. |
| Maxigesic | Experimental | Drug: Maxigesic IV (acetaminophen/ibuprofen)Participants receive the acetaminophen-ibuprofen fixed-dose combination (Maxigesic IV, acetaminophen 1000 mg + ibuprofen 300 mg per 100 mL) on the same schedule as the comparator arm: a 15-minute intravenous infusion every 6 hours, starting 30 minutes before the end of surgery and continuing through 48 hours after surgery (9 doses in total). The total daily acetaminophen dose does not exceed 4 g. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 20 to 80 years diagnosed with gastric cancer by endoscopic biopsy who are scheduled for minimally invasive radical gastrectomy (laparoscopic or robotic)
- Patients scheduled for distal, proximal, or total gastrectomy among minimally invasive procedures (wedge resection, pylorus-preserving gastrectomy, and segmental gastrectomy are not eligible)
- Patients with an ECOG performance status of 0 or 1 and an ASA classification of I-III
- Patients who have voluntarily agreed to participate after receiving a full explanation of the study's purpose and content, and who have signed the written informed consent form approved by the Institutional Review Board
- Patients residing in Korea who are able to complete follow-up for 3 months after surgery
Key exclusion criteria (8 listed)
- Patients with a reported history of hypersensitivity, allergy, or adverse reaction to NSAIDs, opioids, or acetaminophen
- Patients currently taking medications that may affect the study results, such as opioid or non-opioid analgesics, aspirin, warfarin or other anticoagulants, steroids, or high-dose hepatotoxic drugs
- Pregnant or breastfeeding patients
- Patients with a contraindication to NSAIDs or acetaminophen identified from medical history or preoperative evaluation-for example, active liver disease, heart failure, chronic kidney disease, thrombocytopenia, or a history of asthma (peptic ulcer disease is not an exclusion criterion)
- Patients unable to read or understand the informed consent form
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 (Newaminophen Premix)As an active comparator, Newaminophen Premix 100 mL will be administered by 15-minute intravenous infusion every 6 hours during the first 48 hours after surgery. | Drug | Acetaminophen |
| Maxigesic IV (acetaminophen/ibuprofen)Maxigesic 100 mL will be administered as a 15-minute intravenous infusion every 6 hours for the first 48 hours after surgery | Drug | Maxigesic |
Primary outcome
Postoperative pain intensity (NRS)
Time frame: At rest - 0 (immediately postoperatively), 2, 4, 6, 12, 18, 24, 30, 36, 42, and 48 hours after surgery; on movement - 6, 12, 18, 24, 30, 36, 42, and 48 hours after surgery
The primary endpoint is the between-group difference in postoperative pain intensity, measured with the 11-point Numerical Rating Scale (NRS; 0 = no pain, 10 = worst pain imaginable). Pain is assessed both at rest and on movement and is measured repeatedly over the first 48 hours after surgery (at rest from 0 to 48 hours; on movement from 6 to 48 hours). The treatment effect is evaluated as the between-group difference in the time-weighted average (TWA) of NRS over 0-48 hours, estimated using a mixed model for repeated measures (MMRM). A linear mixed model adjusting for covariates (e.g., extent of gastric resection) is performed as a supportive analysis to confirm the consistency of the results.
5 secondary outcomes
Total opioid consumption
Time frame: From the day of operation (day 0) to 72 hours after surgery
Change in Quality of Recovery (QoR-15K)
Time frame: Preoperative, 24 hours aftery surgery, 48 hours after surgery, 72 hours after surgery
Incidence of chronic postsurgical pain (CPSP)
Time frame: At 3 months after surgery (±14 days)
(exploratory analysis) In-hospital cost
Time frame: Through discharge, an average of 5 days
(exploratory analysis) Difference in analgesic efficacy according to genetic polymorphisms
Time frame: Genetic polymorphism assessed preoperatively. NRS scores measured through 72 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 7 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results (primary and secondary clinical outcomes) will be made available to qualified researchers whose proposal is approved by the principal investigator and the Institutional Review Board. Data will be available beginning 12 months after publication of the main results, with no specified end date, under a signed data-use agreement. The study protocol and statistical analysis plan may also be shared on request. Genomic (whole-genome sequencing) data will not be shared owing to re-identification risk and consent and regulatory constraints.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetaminophen (Newaminophen Premix) and Maxigesic IV (acetaminophen/ibuprofen) in people with Stomach Neoplasms and Pain, run by Yonsei University.
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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Hyoung-Il Kim, Professor (+82-2-2228-2100, cairus@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity (NRS) (time frame: At rest - 0 (immediately postoperatively), 2, 4, 6, 12, 18, 24, 30, 36, 42, and 48 hours after surgery; on movement - 6, 12, 18, 24, 30, 36, 42, and 48 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 7 Jul 2026.