Comparison of Fentanyl and Opiranserin Patient-Controlled Analgesia for Early Postoperative Pain Control Following Laparoscopic or Robotic Hysterectomy

Comparison of Fentanyl PCA and Opiranserin PCA for Early Postoperative Pain Control in Patients Undergoing Laparoscopic or Robotic Hysterectomy: A Randomized Non-Inferiority Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0012290

Enrollment

140

Registered

2026-07-16

Start date

2026-08-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

None listed

Interventions

Drug : The intervention in this study is the comparison of two postoperative patient-controlled analgesia (PCA) regimens for pain management following laparoscopic or robotic hysterectomy. All partici

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Provides voluntary written informed consent, understands the study, and can communicate with staff 2) Women aged =19 and <75 years 3) Scheduled for elective laparoscopic or robotic hysterectomy 4) American Society of Anesthesiologists (ASA) physical status I–III

Exclusion criteria

Exclusion criteria: 1) Emergency or unplanned surgery 2) Reoperation for the same disease / repeat laparoscopic surgery 3) Pre-existing pain at/around the surgical site 4) breastfeeding 5) Diagnosed chronic pain (e.g., baseline Numeric Rating Scale [NRS] =5) 6) Unstable/poorly controlled psychiatric disorder (patients on stable antidepressants/anxiolytics =60 days may participate) 7) Unstable medical condition (unstable angina, Congestive Heart Failure [CHF], renal/hepatic failure, AIDS, etc.) 8) Known hypersensitivity to study drugs (opiranserin, fentanyl)

Design outcomes

Primary

Measure	Time frame
Area under the pain-intensity curve over 8 hours (AUC8), from resting Numeric Rating Scale [NRS] at 0,1,2,4,6,8 hours	—

Secondary

Measure	Time frame
Numeric Rating Scale [NRS] at 0,1,2,4,6,8,24,48 hours (rest/movement) and AUC24;24-h total opioid consumption (Morphine Equivalent Dose, MED) and rescue analgesic use;Cumulative Patient-Controlled Analgesia (PCA) use, demand/delivered counts by time point;Incidence and severity of PONV (Postoperative Nausea and Vomiting;Opioid-related adverse drug events (ORADE) composite (ORADE-free rate, count);Proportion reporting mild pain (Numeric Rating Scale, NRS 0–3);Time to first flatus;Patient satisfaction and Subjective degree of recovery relative to preoperative status;Safety/tolerability and study-drug Patient-Controlled Analgesia (PCA) discontinuation	—

Measure

Time frame

Numeric Rating Scale [NRS] at 0,1,2,4,6,8,24,48 hours (rest/movement) and AUC24;24-h total opioid consumption (Morphine Equivalent Dose, MED) and rescue analgesic use;Cumulative Patient-Controlled Analgesia (PCA) use, demand/delivered counts by time point;Incidence and severity of PONV (Postoperative Nausea and Vomiting;Opioid-related adverse drug events (ORADE) composite (ORADE-free rate, count);Proportion reporting mild pain (Numeric Rating Scale, NRS 0–3);Time to first flatus;Patient satisfaction and Subjective degree of recovery relative to preoperative status;Safety/tolerability and study-drug Patient-Controlled Analgesia (PCA) discontinuation

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Countries

Korea, Republic of

Contacts

Public ContactSeungwon Lee

Samsung Medical Center

seungwon0209.lee@samsung.com+82-2-3410-6243

Outcome results