Phase Ⅱ Study of Intercostal Nerve Block With HR18034 for Postsurgical Pain Management
- Conditions
- Thoracoscopic Lobectomy
- Interventions
- Registration Number
- NCT05744674
- Lead Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Brief Summary
Phase Ⅱ, randomized, double-blind, comparator-controlled study to evaluate the efficacy, safety and pharmacokinetics of single injection intercostal nerve block with HR18034 for postoperative pain management compared with ropivacaine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 96
- Able and willing to provide a written informed consent
- Scheduled to undergo thoracoscopic lobectomy under general anesthesia.
- Male or female, aged 18 years and older inclusive
- Body mass index (BMI) 18-30 kg/m2 inclusive
- American Society of Anesthesiologists (ASA) Physical Status Classification Ⅰ~Ⅱ
- Subjects with a history of new myocardial infarction or unstable angina within 6 months prior to randomization;
- Subjects with a history of ischemic stroke or transient ischemic attack (TIA)
- Subjects with a history of mental system diseases and cognitive dysfunction
- Combination of other pain conditions that may affect postoperative pain assessment
- Combination with ventilation disorders caused by airway or spinal anatomical factors, bronchiectasis, and severe chest adhesions on the surgical side
- Clinically significant abnormal clinical laboratory test value
- Allergic to a drug ingredient or component
- Use of any of medications, which affect drug metabolism or analgesia evaluation, within 5 half-lives or as specified prior to the study surgical procedure
- History of alcohol abuse or prescription and/or illicit drug abuse
- Subjects with special diets (including tobacco, grapefruit and caffeine)
- Pregnant or nursing women
- No birth control during the specified period of time
- Participated in clinical trials of other drugs (received experimental drugs)
- The inestigators determined that other conditions were inappropriate for participation in this clinical trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HR18034 HR18034 - Ropivacaine Hydrochloride Injection Ropivacaine Hydrochloride Injection -
- Primary Outcome Measures
Name Time Method AUC0-72 of the NRS-A (or cough) pain intensity scores. 0 to 72 hours AUC of NRS pain intensity scores at activity (NRS-A) through 72 hours after the beginning of study drug administration.
- Secondary Outcome Measures
Name Time Method AUC of the NRS-A (or cough) pain intensity scores. 0-12, 12-24,12-48, 12-72 hours AUC of NRS pain intensity scores at activity (NRS-A) or cough for time periods 0-12, 12-24, 12-48, 12-72 hours.
AUC of the NRS-R pain intensity scores. 0-12, 12-24,12-48, 12-72, 0-72 hours AUC of NRS pain intensity scores at rest (NRS-R) for time periods 0-12, 12-24,12-48, 12-72, 0-72 hours.
Proportion of subjects who used no rescue opioid analgesic. 0-24, 24-48, 48-72, 0-72 hours Proportion of subjects who used no rescue opioid analgesic through 0-24, 24-48, 48-72 and 0-72 hours after the beginning of study drug administration.
Total rescue analgesic consumption. 0-24, 24-48, 48-72, 0-72 hours Total rescue analgesic consumption through 0-24, 24-48, 48-72 and 0-72 hours after the beginning of study drug administration.
Time to the first postoperative use of rescue opioid analgesics. 0-72 hours Time to the first postoperative use of rescue opioid analgesics 0-72 hours after the beginning of study drug administration.
Subjects' satisfaction rating 72 hours Subjects' satisfaction rating with postsurgical pain control at 72 hours.
Investigators' satisfaction rating 72 hours Investigators' satisfaction rating with postsurgical pain control at 72 hours.
Trial Locations
- Locations (1)
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China