Clinical trial NCT06007066: HSK16149 for Perioperative Analgesia in Orthopedic Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post-operative Pain
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-08-23
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This study included patients who have orthopedic surgery under general anesthetic, with expected operation time ≤4h.

Subjects were given 40mg or 60mg of HSK16149 or placebo orally the night before surgery, 2h before surgery, 4h and 16h after surgery, for a total of 4 times during the whole treatment period.

Subjects will receive intravenous patient-controlled analgesia (PCA) morphine for pain in the immediate postoperative period. If PCA is insufficient, rescue analgesia of morphine may be given I.V. as determined by the investigator.

After the treatment period, the subjects will be followed up.

Eligibility criteria: Inclusion Criteria:

1. Male or female between the ages of 18 and 75 years (included);
2. Elective orthopedic surgery under general anesthesia, expected operation time ≤4 hours and postoperative morphine analgesia time ≥24 hours;
3. 18kg/m\^2≤BMI≤30 kg/m\^2;
4. American Society of Anesthesiologists (ASA) grade I and II;

Exclusion Criteria:

1. 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;
2. 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);
3. Abnormal laboratory tests during screening:
4. 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;
5. A history of drug abuse, and/or alcohol abuse in the 3 months prior to screening;
6. Participated in another clinical trial and received IMP within 30 days prior to screening;
7. Pregnant or lactating women;
8. Unwillingness to use reliable contraceptive methods from the time of screening until 28 days after the last dose of IMP;

Primary outcomes:
measure: Morphine Consumption
timeFrame: Participants received PCA pump, an average of 24 hours after surgery
Secondary outcomes:
measure: NRS at rest and during exercise
timeFrame: 1, 2, 6, 12, 18, and 24 hours after surgery
measure: Time of first rescue analgesia with morphine after surgery
timeFrame: Within 24 hours after surgery
measure: Incidence of adverse reactions associated with morphine
timeFrame: Within 24 hours after surgery
measure: The frequency of rescue analgesia with morphine
timeFrame: Within 24 hours after surgery
measure: The total number of PCA presses and the number of effective PCA presses
timeFrame: Within 24 hours after surgery
measure: Daily Sleep Interference Scale (DSIS)
timeFrame: Within 24 hours after surgery
measure: Subjects analgesic satisfaction score
timeFrame: Within 24 hours after surgery
measure: Investigators analgesic satisfaction score
timeFrame: Within 24 hours after surgery
measure: Number of participants with treatment-related adverse events(TEAE) as assessed by CTCAE v5.0.
timeFrame: From enrollment to 72 hours after surgery
Other outcomes:
Locations:
city: Dongguan
country: China
facility: Dongguan People's Hospital
state: Guangdong
city: Foshan
country: China
facility: Foshan Fuxing Chancheng Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
state: Guangdong
city: Guiyang
country: China
facility: Affiliated Hospital of Guizhou Medical University
state: Guizhou
city: Guiyang
country: China
facility: Beijing Jishuitan Hospital Guizhou Hospital
state: Guizhou
city: Zunyi
country: China
facility: Zunyi University Affiliated Hospital
state: Guizhou
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Wuhan
country: China
facility: People's Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Wuhan Central Hospital
state: Hubei
city: Changsha
country: China
facility: Xiangya Third Hospital of Central South University
state: Hunan
city: Hengyang
country: China
facility: The First Affiliated Hospital of South China University
state: Hunan
city: Lianyungang
country: China
facility: Lianyungang First People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Chengdu
country: China
facility: Chengdu Second People's Hospital
state: Sichuan
city: Chengdu
country: China
facility: Chengdu Third People's Hospital
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Guangyuan
country: China
facility: Guangyuan First People's Hospital
state: Sichuan
city: Mianyang
country: China
facility: Mianyang Central Hospital
state: Sichuan
city: Yibin
country: China
facility: Yibin Second People's Hospital
state: Sichuan
city: Kunming
country: China
facility: The First People's Hospital of Yunnan Province
state: Yunnan
city: Beijing
country: China
facility: Sino-Japanese Friendship Hospital
Study officials:
References: