Opiranserin for Minimally Invasive Cholecystectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Opiranserin+Acetaminophen, Acetaminophen+NSAIDs.
- Who it may be relevant to
- Registry conditions: Cholecystectomy, Laparoscopic, Cholecystectomy, Robotic. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Opiranserin/Acetaminophen Versus Ibuprofen/Acetaminophen for Postoperative Pain Management After Minimally Invasive Cholecystectomy: A Randomized, Controlled, Non-inferiority Trial
Overview
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.
Interventions
- Drug Opiranserin+Acetaminophen
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. - Drug Acetaminophen+NSAIDs
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.
Primary outcome measures
- Area under the curve of the pain score at rest through 12 hours (NRS·h) [Time frame: Until 12 hours postoperatively]
Secondary outcome measures (10)
- 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]
Eligibility criteria
Inclusion criteria
- Adult patient undergoing minimally invasive cholecystectomy
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
South Korea · 2 centers
- Gangnam Severance Hospital — Seoul
- Gangnam Severance Hospital — Seoul
Identifiers
NCT: NCT07620665 · 3-2026-0114