Thoracoscopic Lobectomy
Conditions
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.
Interventions
DRUGHR18034
HR18034 228mg/342mg/456mg
Ropivacaine Hydrochloride Injection 60mg/90mg/120mg
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
HR18034 compared with active comparator
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able and willing to provide a written informed consent 2. Scheduled to undergo thoracoscopic lobectomy under general anesthesia. 3. Male or female, aged 18 years and older inclusive 4. Body mass index (BMI) 18-30 kg/m2 inclusive 5. American Society of Anesthesiologists (ASA) Physical Status Classification Ⅰ\ Ⅱ
Exclusion criteria
1. Subjects with a history of new myocardial infarction or unstable angina within 6 months prior to randomization; 2. Subjects with a history of ischemic stroke or transient ischemic attack (TIA) 3. Subjects with a history of mental system diseases and cognitive dysfunction 4. Combination of other pain conditions that may affect postoperative pain assessment 5. Combination with ventilation disorders caused by airway or spinal anatomical factors, bronchiectasis, and severe chest adhesions on the surgical side 6. Clinically significant abnormal clinical laboratory test value 7. Allergic to a drug ingredient or component 8. 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 9. History of alcohol abuse or prescription and/or illicit drug abuse 10. Subjects with special diets (including tobacco, grapefruit and caffeine) 11. Pregnant or nursing women 12. No birth control during the specified period of time 13. Participated in clinical trials of other drugs (received experimental drugs) 14. The inestigators determined that other conditions were inappropriate for participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactQin Liu
Outcome results
None listed