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

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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04794738

Enrollment

192

Registered

2021-03-12

Start date

2021-04-18

Completion date

2021-10-30

Last updated

2021-08-12

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

Conditions

Pain

Brief summary

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

Interventions

DRUGSHR8554

SHR8554 Injection; high dose

DRUGSaline Solution

Saline Solution

DRUGMorphine

Morphine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Parallel Assignment

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. Able and willing to provide a written informed consent 2. Subjects requiring elective general anesthesia orthopedic surgery 3. Conform to the ASA Physical Status Classification

Exclusion criteria

1. Subjects with a history of difficult airway 2. Subjects with a history of reflux esophagitis 3. Subjects with a history of mental illness 4. Subjects with poor blood pressure control 5. Transcutaneous oxygen saturation (SpO2) \<90% 6. Random blood glucose ≥11.1mmol/L 7. Subjects with abnormal liver function 8. allergies to opioids and other medications that may be used during the trial 9. Pregnant or nursing women

Design outcomes

Primary

Measure	Time frame	Description
the Sum of Pain Intensity Differences in Pain Score Over 48 Hours in the rest state	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

Measure	Time frame
the Sum of Pain Intensity Differences in Pain Score Over 6、12、24、48 、12-24、24-48 Hours under moving condition	48-hours
Time of first use of remedial analgesic medication	48-hours
the Sum of Pain Intensity Differences in Pain Score Over 6、12、48 、12-24、24-48 Hours under static condition	48-hours
Participant ' satisfaction score for analgesia treatment	48-hours
Investigator satisfaction score for analgesia treatment	48-hours
Cumulative use of remedial analgesics from 0h to 48h	48-hours

Countries

China

Contacts

Primary ContactYong Cao, M.M

caoyong@hrs.com.cn+0518-81220121

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026