HSK16149 for Perioperative Analgesia in Orthopedic Surgery
A Multicenter, Randomized, Double-Blind, Placebo-controlled Phase II Study of The Efficacy And Safety of HSK16149 In The Treatment of Patients With Orthopedic Perioperative Analgesia
1 other identifier
interventional
235
1 country
21
Brief Summary
This study will compare the effect and safety of HSK16149 with placebo on perioperative analgesia in orthopedic surgery, and explore the dosage of HSK16149 capsules for orthopedic analgesia during perioperative period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 postoperative-pain
Started Mar 2023
Shorter than P25 for phase_2 postoperative-pain
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2023
CompletedStudy Start
First participant enrolled
March 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 12, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 5, 2023
CompletedFirst Posted
Study publicly available on registry
August 23, 2023
CompletedAugust 23, 2023
August 1, 2023
3 months
March 5, 2023
August 17, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Morphine Consumption
IV Patient Controlled Analgesia (PCA) morphine for pain management in the immediate postoperative period for an average of 24 hours after surgery. If PCA is insufficient, rescue analgesia of morphine may be given I.V. as determined by the investigator. Total morphine consumption = PCA morphine consumption + rescue analgesia morphine consumption.
Participants received PCA pump, an average of 24 hours after surgery
Secondary Outcomes (9)
NRS at rest and during exercise
1, 2, 6, 12, 18, and 24 hours after surgery
Time of first rescue analgesia with morphine after surgery
Within 24 hours after surgery
Incidence of adverse reactions associated with morphine
Within 24 hours after surgery
The frequency of rescue analgesia with morphine
Within 24 hours after surgery
The total number of PCA presses and the number of effective PCA presses
Within 24 hours after surgery
- +4 more secondary outcomes
Study Arms (5)
Preoperative administration of HSK16149 40mg
EXPERIMENTALHSK16149 40mg will be administered the night before and 2h before surgery
Preoperative administration of HSK16149 60mg
EXPERIMENTALHSK16149 60mg will be administered the night before and 2h before surgery
Preoperative and postoperative administration of HSK16149 40mg
EXPERIMENTALHSK16149 40mg will be administered orally the night before surgery, 2h before surgery, 4h and 16h after surgery
Preoperative and postoperative administration of HSK16149 60mg
EXPERIMENTALHSK16149 60mg will be administered orally the night before surgery, 2h before surgery, 4h and 16h after surgery
placebo
PLACEBO COMPARATORThe placebo will be administered orally the night before surgery, 2h before surgery, 4h and 16h after surgery
Interventions
Subjects will be given 40mg or 60mg of HSK16149 orally.
Eligibility Criteria
You may qualify if:
- Male or female between the ages of 18 and 75 years (included);
- Elective orthopedic surgery under general anesthesia, expected operation time ≤4 hours and postoperative morphine analgesia time ≥24 hours;
- kg/m\^2≤BMI≤30 kg/m\^2;
- American Society of Anesthesiologists (ASA) grade I and II;
You may not qualify if:
- Any of the following medical histories or conditions prior to screening:
- Long history of chronic pain;
- history of severe cardiovascular or respiratory disease;
- history of neurological or psychiatric disorders;
- history of acute poisoning with alcohol, hypnotics, analgesics or other drugs acting on the central nervous system;
- major surgery within 3 months;
- patients with high bleeding risk;
- history of renal disease treated with dialysis within 28 days before surgery;
- have active infection within the past 2 weeks;
- Use of any of the following medications or treatments:
- opioid analgesics for more than 10 consecutive days within 3 months prior to screening;
- other analgesics before randomization if the last dose was taken less than 5 half-lives of the drug (according to the label);
- Abnormal laboratory tests during screening:
- Hypertension that is not adequately controlled by antihypertensive drugs (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg), or systolic blood pressure ≤90 mmHg during screening;
- A history of drug abuse, and/or alcohol abuse in the 3 months prior to screening;
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Dongguan People's Hospital
Dongguan, Guangdong, China
Foshan Fuxing Chancheng Hospital
Foshan, Guangdong, China
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Beijing Jishuitan Hospital Guizhou Hospital
Guiyang, Guizhou, China
Zunyi University Affiliated Hospital
Zunyi, Guizhou, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
People's Hospital of Wuhan University
Wuhan, Hubei, China
Wuhan Central Hospital
Wuhan, Hubei, China
Xiangya Third Hospital of Central South University
Changsha, Hunan, China
The First Affiliated Hospital of South China University
Hengyang, Hunan, China
Lianyungang First People's Hospital
Lianyungang, Jiangsu, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Chengdu Second People's Hospital
Chengdu, Sichuan, China
Chengdu Third People's Hospital
Chengdu, Sichuan, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Guangyuan First People's Hospital
Guangyuan, Sichuan, China
Mianyang Central Hospital
Mianyang, Sichuan, China
Yibin Second People's Hospital
Yibin, Sichuan, China
The First People's Hospital of Yunnan Province
Kunming, Yunnan, China
Sino-Japanese Friendship Hospital
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2023
First Posted
August 23, 2023
Study Start
March 8, 2023
Primary Completion
June 12, 2023
Study Completion
July 5, 2023
Last Updated
August 23, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share