Postoperative Pain
Conditions
Brief summary
This clinical trial is a multiple-center, randomized, double-blind, placebo- and active-controlled parallel-group Phase II/III clinical trial, to evaluate the efficacy and safety of HL-1186 Tablets for Postoperative Analgesia in Orthopedic Surgery.
Interventions
DRUGHL-1186
HL-1186 tablet for oral administration.
DRUGHL-1186 placebo
HL-1186 placebo tablet for oral administration.
Oxycodone-Acetaminophen for oral adminstration
Oxycodone-Acetaminophen Matching Placebo for oral adminstration
Sponsors
Shanghai Huilun Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 18 years old ≤ age ≤ 75 years old, gender is not limited. 2. 18 kg/m2 ≤ Body Mass Index (BMI) ≤ 30kg/m2. 3. Scheduled to undergo orthopedic surgery under general anesthesia, with expected moderate-to-severe postoperative pain intensity. 4. Able to understand the research process and the use of pain scales, and communicate effectively with researchers. 5. After surgery completion, the participant is judged by the investigator to be awake and has a resting NRS score ≥ 4.
Exclusion criteria
1. Previous surgery on the same site that may affect pain perception at the surgical site. 2. Paresthesia or other pain that may affect postoperative pain evaluation or scale assessment. 3. Neuropsychological disorders that may affect postoperative pain evaluation or scale assessment. 4. Unstable angina, myocardial infarction, severe arrhythmia, NYHA cardiac function class ≥ III, or recurrent asthma attacks, etc., deemed unsuitable for inclusion by the investigator. 5. Poorly controlled hypertension. 6. Sleep apnea syndrome, or the presence of a difficult airway as assessed by the investigator. 7. Known allergy to any component of the investigational drug(s), to perioperative (from induction of anesthesia to completion of surgery) anesthetic/analgesic/antiemetic drugs, or a history of allergy to ≥ 3 substances. 8. Positive for human immunodeficiency virus (HIV) antibody; positive for Treponema pallidum antibody and positive toluidine red unheated serum test (TRUST); positive for hepatitis B surface antigen (HBsAg) with detectable HBV-DNA; or positive for hepatitis C virus (HCV) antibody. 9. Women who are pregnant or breastfeeding (within 1 year after delivery). 10. Participation in another drug or medical device trial within 1 month before screening, or currently participating in another clinical trial receiving investigational intervention. 11. Any other condition considered unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SPID48 | 0 to 48 hours | SPID48: Time-weighted Sum of the Pain Intensity Difference (SPID) as recorded on an NRS (Numeric Rating Scale, 0 =no pain to 10 =worst possible pain) at rest 0 to 48 hours after the first dose of study drug. The score range was -480 (worst score) to 480 (best score). |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-related adverse events | 0-9 days |
Countries
China
Contacts
CONTACTMeiXuan Li
Outcome results
None listed