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Completed

NCT Number: NCT04766463

A Clinical Study of SHR8554 Injection for the Treatment of Pain After Abdominal Surgery.

The primary objective is to evaluate the analgesic efficacy of IV SHR8554 compared with placebo and morphine in patients with acute postoperative pain following abdominal surgery

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Union Hospital Affiliated to Tongji Medical Collage Huazhong University of Science and Technology

Wuhan, 430021, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Able and willing to provide a written informed consent
  • Subjects requiring elective general anesthesia abdominal surgery
  • Conform to the ASA Physical Status Classification

Exclusion criteria

  • Subjects with a history of difficult airway
  • Subjects with a history of reflux esophagitis
  • Subjects with a history of mental illness
  • Subjects with poor blood pressure control
  • Transcutaneous oxygen saturation (SpO2) <90%
  • Random blood glucose ≥11.1mmol/L
  • Subjects with abnormal liver function
  • allergies to opioids and other medications that may be used during the trial
  • Pregnant or nursing women

Treatment and study plan

SHR8554 Injection

Drug

SHR8554 Injection; high dose

Placebo

Drug

Saline Solution

Morphine

Drug

Morphine

Primary outcomes

  1. the Sum of Pain Intensity Differences in Pain Score Over 24 Hours

    Time frame: 24-hours

    Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 24 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (24 hours) to yield values on the 0-10 NPRS.

Secondary outcomes

  1. the Sum of Pain Intensity Differences in Pain Score Over 6、12、18 、12-18 Hours

    Time frame: 6-hours、12-hours、18-hours、12-18 hours

    time weighted sum of pain intensity differences (SPID) divided by a constant (6、12、18 、12-18 hours) to yield values on the 0-10 NPRS.

  2. Time of first use of remedial analgesic medication

    Time frame: 24-hours

    The first time to use parecoxib sodium for injection

  3. Cumulative use of remedial analgesics from 0h to 24h

    Time frame: 24-hours

    Cumulative use of parecoxib sodium for injection / sufentanil hydrochloride injection

  4. Participant ' satisfaction score for analgesia treatment

    Time frame: 24-hours

    Participants recalled the postoperative analgesia effect and rated their satisfaction on a scale of 0 to 10, with 0 representing dissatisfied and 10 representing very satisfied.

  5. Investigator satisfaction score for analgesia treatment

    Time frame: 24-hours

    Postoperative analgesia was evaluated by investigators.The scale ranges from 0 to 10, with 0 being dissatisfied and 10 being very satisfied.

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Phase III, Randomized, Double-Blind, Placebo- and Active-controlled Study of SHR8554 Injection for the Treatment of Pain After Abdominal Surgery.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 23, 2021
Registry last updated
Jul 6, 2022

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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