Cholecystectomy, LaparoscopicNCT07620665
Opiranserin for Minimally Invasive Cholecystectomy
A study testing Opiranserin+Acetaminophen and Acetaminophen+NSAIDs in people with Cholecystectomy, Laparoscopic and Cholecystectomy, Robotic, run by Gangnam Severance Hospital at 2 sites in South Korea.
Trial summary
The purpose of this study is to evaluate whether the combination therapy of opiranserin and acetaminophen is non-inferior to the combination of non-steroidal anti-inflammatory drugs (NSAIDs) and acetaminophen for postoperative pain management after minimally invasive cholecystectomy. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cholecystectomy, Laparoscopic, Cholecystectomy, Robotic
- What is being tested?
- Opiranserin+Acetaminophen and Acetaminophen+NSAIDs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 10 Jun 2026to 30 May 2028
- Phase
- Interventional
- 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
- Adult patient undergoing minimally invasive cholecystectomy
Who cannot join
- Known hypersensitivity or allergy to acetaminophen, NSAIDs, opiranserin, or fentanyl.
- pre-existing chronic pain,
- clinically significant ECG findings (QRS > 200 msec, QTcF >450 msec)
- severe renal impairment
- severe hepatic impairment
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea2 sites, 2 recruiting
- Not yet recruiting
Gangnam Severance Hospital
Seoul, 06273
Young Song
- Recruiting
Gangnam Severance Hospital
Seoul, 06273
Sun-Kyung Park, 01024505924, mayskpark@gmail.com
About this study
Official title: Comparison of Opiranserin/Acetaminophen Versus Ibuprofen/Acetaminophen for Postoperative Pain Management After Minimally Invasive Cholecystectomy: A Randomized, Controlled, Non-inferiority Trial
The purpose of this study is to evaluate whether the combination therapy of opiranserin and acetaminophen is non-inferior to the combination of non-steroidal anti-inflammatory drugs (NSAIDs) and acetaminophen for postoperative pain management after minimally invasive cholecystectomy.
This is a single-center, randomized, controlled, non-inferiority clinical trial in adult patients undergoing minimally invasive cholecystectomy. Participants will be randomly assigned to either the Treatement group (opiranserin + acetaminophen) or the control group (NSAIDs + acetaminophen) in a 1:1 ratio to compare the analgesic efficacy and safety between the two analgesic regimens.
- Being tested
- Opiranserin+Acetaminophen, Acetaminophen+NSAIDs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opiranserin+AcetaminophenDrug
Also called Arm I
In the Opiranserin+Acetaminophen group, opiranserine 1000mg infusion will be provided over 10 hr. Opiranserin infusion will be started after the indduction of anesthesia. After laoding dose (160mg ) over 30 minutes, maintenace dose (840mg) will be infused over 9hr 30min. IV Acetaminophen 1g will be provided q 8h until 24 h potperatively.
Acetaminophen+NSAIDsDrug
Also called Arm II
In the Acetaminophen+NSAIDs group, Normal saline 500 ml will be provided over 10hr. IV Acetaminophen 1g and ibuprofen 300mg will be provided q 8h until 24 h potperatively.
| Study group | Role | What they receive |
|---|---|---|
| Opiranserin+Acetaminophen group | Experimental | In the Opiranserin+Acetaminophen group, opiranserine 1000mg infusion will be provided over 10 hr. IV Acetaminophen 1g will be provided q 8h until 24 h potperatively. Receives: Drug: Opiranserin+Acetaminophen |
| Acetaminophen+NSAIDs group | Active comparator | In the Acetaminophen+NSAIDs group, Normal saline 500 ml will be provided over 10hr. IV Acetaminophen 1g and ibuprofen 300mg will be provided q 8h until 24 h potperatively. Receives: Drug: Acetaminophen+NSAIDs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve of the pain score at rest through 12 hours (NRS·h)
Area under the curve of the numeric rating scale pain score at rest through 12 hours (Numerical Rating Scale·h), Pain score will be assess with the numerical rating scale (NRS), ranging from 0 (0, no pain) to 10 (maximum, worst pain), higher scores indicate greater pain intensity.
Measured: Until 12 hours postoperatively
Secondary outcomes (10)
Area under the curve of the pain score at rest through 24 hours
Area under the curve of the numeric rating scale pain score at rest through 24 hours.
Area under the curve of the numeric rating scale pain score at rest through 24 hours (Numerical Rating Scale·h), Pain score will be assess with the numerical rating scale (NRS), ranging from 0 (0, no pain) to 10 (maximum, worst pain), higher scores indicate greater pain intensity.
Measured: until 24hours postoperatively
opioid consumption
Measured: until 24hours postopratively
pain at rest
numeric rating scale pain score at rest, Pain score will be assess with the numerical rating scale (NRS), ranging from 0 (0, no pain) to 10 (maximum, worst pain), higher scores indicate greater pain intensity.
Measured: at 0.5, 2, 4, 6, 12, 18, 24hours postoperatively
pain during movement
numeric rating scale pain score during movement Pain score will be assess with the numerical rating scale (NRS), ranging from 0 (0, no pain) to 10 (maximum, worst pain), higher scores indicate greater pain intensity.
Measured: at 0.5, 2, 4, 6, 12, 18, 24hours postoperatively
time to first rescue analgesics
time to first rescue analgesic requirements
Measured: until 24hours
incidence of nausea, vomiting
incidence of nausea, vomiting during postoperative 24 hours
Measured: until 24hours
nausea severity
severity of nausea using 0-10 numeric rating scale Nausea severity will be assess with the numerical rating scale (NRS), ranging from 0 (0, no nausea) to 10 (maximum, worst nausea), higher scores indicate greater nausea severity.
Measured: until 24hours
patient satisfaction
patient satisfaction regarding pain management asked at 24 hours postoperatively, using 0-10 scale Patient satisfaction will be assessd with the numerical rating scale (NRS), ranging from 0 (0, totally unsatisfied) to 10 (maximum, totally satisfied), higher scores indicate greater patient satisfaction.
Measured: 24hours postoperatively
hospital length of stay
length of hospitalization
Measured: until discharge, about 1-7 days
Quality of Recovery
Questionnaire of 15-item Quality of Recovery (QoR-15). Each item is scored on an 11-point numerical rating scale from 0 to 10. Total score range: Minimum 0 to maximum 150. Higher values indicate a better quality of postoperative recovery.
Measured: 24hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start10 Jun 2026
- Primary completion25 May 2028 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystectomy, LaparoscopicStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either the Treatement group (opiranserin + acetaminophen) or the control group (NSAIDs + acetaminophen) in a 1:1 ratio.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Song, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620665
- Sponsor's protocol ID
- 3-2026-0114
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Opiranserin/Acetaminophen Versus Ibuprofen/Acetaminophen for Postoperative Pain Management After Minimally Invasive Cholecystectomy: A Randomized, Controlled, Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT07620665
- Acronym / sponsor ID
- 3-2026-0114
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 25 May 2028 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 2 Jun 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.
The purpose of this study is to evaluate whether the combination therapy of opiranserin and acetaminophen is non-inferior to the combination of non-steroidal anti-inflammatory drugs (NSAIDs) and acetaminophen for postoperative pain management after minimally invasive cholecystectomy.
This is a single-center, randomized, controlled, non-inferiority clinical trial in adult patients undergoing minimally invasive cholecystectomy. Participants will be randomly assigned to either the Treatement group (opiranserin + acetaminophen) or the control group (NSAIDs + acetaminophen) in a 1:1 ratio to compare the analgesic efficacy and safety between the two analgesic regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the Treatement group (opiranserin + acetaminophen) or the control group (NSAIDs + acetaminophen) in a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Opiranserin+Acetaminophen group | Experimental | Drug: Opiranserin+AcetaminophenIn the Opiranserin+Acetaminophen group, opiranserine 1000mg infusion will be provided over 10 hr. IV Acetaminophen 1g will be provided q 8h until 24 h potperatively. |
| Acetaminophen+NSAIDs group | Active comparator | Drug: Acetaminophen+NSAIDsIn the Acetaminophen+NSAIDs group, Normal saline 500 ml will be provided over 10hr. IV Acetaminophen 1g and ibuprofen 300mg will be provided q 8h until 24 h potperatively. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patient undergoing minimally invasive cholecystectomy
Key exclusion criteria (5 listed)
- Known hypersensitivity or allergy to acetaminophen, NSAIDs, opiranserin, or fentanyl.
- pre-existing chronic pain,
- clinically significant ECG findings (QRS > 200 msec, QTcF >450 msec)
- severe renal impairment
- severe hepatic impairment
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 |
|---|---|---|
| Opiranserin+AcetaminophenAlso: Arm IIn the Opiranserin+Acetaminophen group, opiranserine 1000mg infusion will be provided over 10 hr. Opiranserin infusion will be started after the indduction of anesthesia. After laoding dose (160mg ) over 30 minutes, maintenace dose (840mg) will be infused over 9hr 30min. IV Acetaminophen 1g will be provided q 8h until 24 h potperatively. | Drug | Opiranserin+Acetaminophen group |
| Acetaminophen+NSAIDsAlso: Arm IIIn the Acetaminophen+NSAIDs group, Normal saline 500 ml will be provided over 10hr. IV Acetaminophen 1g and ibuprofen 300mg will be provided q 8h until 24 h potperatively. | Drug | Acetaminophen+NSAIDs group |
Primary outcome
Area under the curve of the pain score at rest through 12 hours (NRS·h)
Time frame: Until 12 hours postoperatively
Area under the curve of the numeric rating scale pain score at rest through 12 hours (Numerical Rating Scale·h), Pain score will be assess with the numerical rating scale (NRS), ranging from 0 (0, no pain) to 10 (maximum, worst pain), higher scores indicate greater pain intensity.
10 secondary outcomes
Area under the curve of the pain score at rest through 24 hours
Time frame: until 24hours postoperatively
opioid consumption
Time frame: until 24hours postopratively
pain at rest
Time frame: at 0.5, 2, 4, 6, 12, 18, 24hours postoperatively
pain during movement
Time frame: at 0.5, 2, 4, 6, 12, 18, 24hours postoperatively
time to first rescue analgesics
Time frame: until 24hours
incidence of nausea, vomiting
Time frame: until 24hours
nausea severity
Time frame: until 24hours
patient satisfaction
Time frame: 24hours postoperatively
hospital length of stay
Time frame: until discharge, about 1-7 days
Quality of Recovery
Time frame: 24hours postoperatively
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 18 Jun 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opiranserin+Acetaminophen and Acetaminophen+NSAIDs in people with Cholecystectomy, Laparoscopic and Cholecystectomy, Robotic, run by Gangnam Severance Hospital at 2 sites 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 1 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 Young Song (02-2019-6692, NEARMYHEART@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve of the pain score at rest through 12 hours (NRS·h) (time frame: Until 12 hours postoperatively). 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 18 Jun 2026.