Opiranserin for Minimally Invasive Cholecystectomy

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.

Study Overview

• Status: Recruiting
• Conditions: Cholecystectomy, Laparoscopic; Cholecystectomy, Robotic
• Intervention / Treatment: Drug: Opiranserin+Acetaminophen; Drug: Acetaminophen+NSAIDs

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Young Song; Phone Number: 02-2019-6692; Email: NEARMYHEART@yuhs.ac

Study Locations

• South Korea
  • Seoul, South Korea, 06273
    • Recruiting
    • Gangnam Severance Hospital
    • Contact: Sun-Kyung Park; Phone Number: 01024505924; Email: mayskpark@gmail.com
  • Seoul, South Korea, 06273
    • Not yet recruiting
    • Gangnam Severance Hospital
    • Contact: Young Song

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Opiranserin+Acetaminophen group; 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.	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.; Other Names: Arm I
Active Comparator: Acetaminophen+NSAIDs group; 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.	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.; Other Names: Arm II

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Until 12 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
opioid consumption		until 24hours postopratively
time to first rescue analgesics	time to first rescue analgesic requirements	until 24hours
incidence of nausea, vomiting	incidence of nausea, vomiting during postoperative 24 hours	until 24hours
hospital length of stay	length of hospitalization	until discharge, about 1-7 days
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.	until 24hours postoperatively
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.	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.	at 0.5, 2, 4, 6, 12, 18, 24hours postoperatively
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.	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.	24hours postoperatively
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.	24hours postoperatively

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2026
• Primary Completion (Estimated): May 25, 2028
• Study Completion (Estimated): May 30, 2028

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 3-2026-0114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No