Postsurgical Pain Management
Conditions
Brief summary
The study is being conducted to evaluate the efficacy, safety of HR021618 and to explore the reasonable dosage of HR021618 for Pain Management after Orthopaedic surgery.
Interventions
DRUGHR021618
Treatment group A:HR021618; high dose
DRUGPlacebo
Treatment group C: HR021618 blank preparation.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
HR021618 compared with placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Able and willing to provide a written informed consent 2. Subjects requiring elective Orthopaedic surgery 3. Male or female 4. Meet the weight standard 5. Conform to the ASA Physical Status Classification Postoperative randomization criteria
Exclusion criteria
1、 Sufficient pain to require IVanalgesia assessed by NRS ranging 2、 No evidence of organ insufficiency, or any other abnormality, during or following surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usage of Morphine, Post Surgery | 0 hour to 24 hours after IP administration | Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 24 hour period post IP administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Usage of Morphine, Post Surgery at other intervals | 0 hour to 48 hours after IP administration | Change in the amount of morphine use (in milligrams) by subjects in each treatment group for 0-48 hours after IP administration. |
| Pain intensity assessed using an 11-point NRS ranging | Baseline till 48 hours post IP administration | 11-point NPRS ranging from a score of 0 to 10. |
| Pain relief assessed using an 5-point likert scale | Baseline till 48 hours post IP administration | 5-point likert scale from a score of 0 to 4. |
| Frequency of Doses of Rescue Analgesia Utilized Per Subject | 0 hour to 48 hours after IP administration | Rescue analgesia was available to subjects with inadequately controlled pain upon request. |
| Proportion of subjects who received Rescue Analgesia | 0 hour to 48 hours after IP administration | Proportion of rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia. |
| Patient Global Assessment (PGA) of Pain Control | 0 hour to 48 hours after IP administration | PGA of pain control was evaluated by subject reported degree of pain control according to a 5 point scale (0-4) |
| Time to First Dose of Rescue Analgesia | 0 hour to 48 hours after IP administration | Time to first rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia. |
Countries
China
Outcome results
None listed