NCT07620665

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
22mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Jun 2026May 2028

First Submitted

Initial submission to the registry

May 27, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 2, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

June 10, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2028

Expected
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2028

Last Updated

June 18, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

May 27, 2026

Last Update Submit

June 16, 2026

Conditions

Cholecystectomy, RoboticCholecystectomy, Laparoscopic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Area under the curve of the pain score at rest through 24 hours

    until 24hours postoperatively

  • opioid consumption

    until 24hours postopratively

  • pain at rest

    at 0.5, 2, 4, 6, 12, 18, 24hours postoperatively

  • pain during movement

    at 0.5, 2, 4, 6, 12, 18, 24hours postoperatively

  • time to first rescue analgesics

    until 24hours

  • +5 more secondary outcomes

Study Arms (2)

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.

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.

Drug: Acetaminophen+NSAIDs

Interventions

Opiranserin+AcetaminophenDRUG

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.

Also known as: Arm I
Opiranserin+Acetaminophen group
Acetaminophen+NSAIDsDRUG

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.

Also known as: Arm II
Acetaminophen+NSAIDs group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patient undergoing minimally invasive cholecystectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gangnam Severance Hospital

Seoul, 06273, South Korea

NOT YET RECRUITING

Gangnam Severance Hospital

Seoul, 06273, South Korea

RECRUITING

Central Study Contacts

Young Song

CONTACT

02-2019-6692NEARMYHEART@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants, care providers, investigators, and oucome assessors will be blinded to the group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either the Treatement group (opiranserin + acetaminophen) or the control group (NSAIDs + acetaminophen) in a 1:1 ratio.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 27, 2026

First Posted

June 2, 2026

Study Start

June 10, 2026

Primary Completion (Estimated)

May 25, 2028

Study Completion (Estimated)

May 30, 2028

Last Updated

June 18, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(2)