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Completed

NCT Number: NCT07821307

Opiranserin Injections PCA Regimens for Postoperative Pain

The purpose of this phase 2 study is to evaluate the efficacy and safety of PCA regimen of opiranserin (VVZ-149) injections in patients undergoing laparoscopic colectomy.

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Key information

Conditions

Pain, Postoperative / Acute Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Samsung Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must have the ability to voluntarily provide written informed consent, understand study
  • Men and women subjects aged ≥19 years and <75 years
  • Female subjects who are not pregnant or breastfeeding
  • Subjects must be undergoing a planned first laparoscopic colectomy
  • Subjects classified in American Society Anesthesiologist (ASA) risk class of I or II

Exclusion criteria

  • Subjects undergoing emergency or unplanned surgery
  • Subjects who had a previous laparoscopic colectomy or resection procedure
  • Subjects with pre-existing conditions causing preoperative pain around the site of surgery
  • Female subjects who are pregnant or breastfeeding
  • Diagnosis of chronic pain (e.g., persistent pain with the intensity of NRS ≥ 5 at baseline)

Treatment and study plan

VVZ-149 Injections

Drug

VVZ-149 injections mixed with normal saline will be intravenously infused as a 180 mg loading dose over 30 minutes, starting from the initiation of surgical closure. After recovery from anesthesia, VVZ-149 injections will be administered via PCA (VVZ-149 10 mg in 2 mL, 10-min lock-out, basal infusion 6 mL/h)

Other names: opiranserin Injections

Fentanyl

Drug

VVZ-149 injections mixed with normal saline will be intravenously infused as a 180 mg loading dose over 30 minutes, starting from the initiation of surgical closure. After recovery from anesthesia, VVZ-149 injections + fentanyl will be administered (VVZ-149 injections 10 mg + fentanyl 4 μg in 2 mL, 10-min lock-out, basal infusion 6 mL/h)

Primary outcomes

  1. Area under the pain intensity-time curve over 8 hours (AUC 8)

    Time frame: 0-8 hours post-emergence

    Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0 (no pain) to 10 (worst pain imaginable). The area under the curve of the pain intensity over time graph from 0 to 8 hours will be calculated using pain intensity measured at scheduled time points and pre-rescue medication time points, as well as imputed values.

Secondary outcomes

  1. Number of PCA and rescue medication use and requests, and consumption measured at 2 hours for 12 hours post-emergence

    Time frame: 0-12 hours post-emergence

    The total number of patient-controlled analgesia (PCA) requests and consumption from Time 0 to 12 hours was compared between the two groups.

  2. Number of PCA and rescue medication use and requests, and consumption measured at 6 hours for 24 hours post-emergence

    Time frame: 0-12 hours post-emergence

    Total amount of PCA and rescue medication consumption from Time 0 to Time 24 hours was compared between the two groups.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Vivozon, Inc.

Registry information

Official study title

A Phase 2, Randomized, Double-Blind, Parallel Group, Exploratory Study to Evaluate the Efficacy and Safety of PCA Regimen of VVZ-149 Injections for the Treatment of Post-Operative Pain

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 15, 2026
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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