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Completed

NCT Number: NCT05375305

A Study of SHR8554 Injection for the Treatment of Pain After Orthopedic Surgery

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Shanghai Jiaotong University School of Medicine,Renji Hospital

Shanghai, Shanghai Municipality, 200127, 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 orthopedic 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

Treatment and study plan

SHR8554 Injection

Drug

SHR8554 Injection; high dose

Saline Solution

Drug

Saline Solution

Morphine

Drug

Morphine

Primary outcomes

  1. the Sum of Pain Intensity Differences in Pain Score Over 48 Hours in the rest state

    Time frame: 48-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 48 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (48 hours) to yield values on the 0-10 NPRS.

Secondary outcomes

  1. the Sum of Pain Intensity Differences in Pain Score Over 6、12、24、 48 、12-24、24-48 Hours under static and moving condition

    Time frame: 48-hours

  2. Time of first use of remedial analgesic medication

    Time frame: 48-hours

  3. Cumulative use of remedial analgesics from 0h to 48h

    Time frame: 48-hours

  4. Participant ' satisfaction score for analgesia treatment

    Time frame: 48-hours

  5. Investigator satisfaction score for analgesia treatment

    Time frame: 48-hours

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

A Phase II/Ⅲ, Randomized, Double-Blind, Dose-explored, Active-controlled Study of SHR8554 Injection for the Treatment of Pain After Orthopedic Surgery

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 16, 2022
Registry last updated
Dec 26, 2023

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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