A Study to Reduce Pain and Opioid Use After Gallbladder Surgery

Effect of opiranserin-Based Multimodal Analgesia on Postoperative Opioid-Free Recovery in Patients Undergoing Laparoscopic and Robotic Cholecystectomy: A Prospective Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0012386

Enrollment

Registered

2026-08-03

Start date

2026-08-07

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : This is a randomized, triple-blind clinical study involving patients undergoing laparoscopic or robotic cholecystectomy. Participants in the intervention group (Group U) will receive Unafra® (O

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults aged 19 to 80 years. 2. Patients scheduled to undergo laparoscopic or robotic cholecystectomy. 3. American Society of Anesthesiologists (ASA) physical status I–III. 4. Patients who are able to understand the study procedures and provide written informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. Patients with a known hypersensitivity or allergy to the study drug or any of its components. 2. Pregnant or breastfeeding women. 3. Patients with severe hepatic or renal impairment. 4. Patients receiving chronic opioid therapy before surgery. 5. Patients with severe psychiatric or neurological disorders that may interfere with study assessments. 6. Patients considered unsuitable for participation by the investigator. 7. Patients who do not provide written informed consent.

Design outcomes

Primary

Measure	Time frame
Proportion of patients achieving opioid-free recovery (no opioid use within 24 hours after surgery)	—

Secondary

Measure	Time frame
Postoperative pain intensity measured using the Numeric Rating Scale (NRS);Total postoperative opioid consumption (Morphine Milligram Equivalents, MME);Requirement for rescue opioid analgesics;Intraoperative Analgesia Nociception Index (ANI);Incidence of postoperative nausea and vomiting (PONV);Sedation level assessed using the Richmond Agitation-Sedation Scale (RASS);Requirement for rescue non-opioid analgesics;Incidence of adverse events and adverse drug reactions	—

Measure

Time frame

Postoperative pain intensity measured using the Numeric Rating Scale (NRS);Total postoperative opioid consumption (Morphine Milligram Equivalents, MME);Requirement for rescue opioid analgesics;Intraoperative Analgesia Nociception Index (ANI);Incidence of postoperative nausea and vomiting (PONV);Sedation level assessed using the Richmond Agitation-Sedation Scale (RASS);Requirement for rescue non-opioid analgesics;Incidence of adverse events and adverse drug reactions

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Countries

Korea, Republic of

Contacts

Public ContactHyunyoung Seong

Korea University Anam Hospital

hello406@naver.com+82-2-920-5632

Outcome results