Clinical trial NCT05744674: Phase Ⅱ Study of Intercostal Nerve Block With HR18034 for Postsurgical Pain Management
Official title: A Phase Ⅱ Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Single Injection Intercostal Nerve Block With HR18034 for Postoperative Pain Management
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Thoracoscopic Lobectomy
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-02-27
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: HR18034 compared with active comparator
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: AUC0-72 of the NRS-A (or cough) pain intensity scores.
timeFrame: 0 to 72 hours
Secondary outcomes:
measure: AUC of the NRS-A (or cough) pain intensity scores.
timeFrame: 0-12, 12-24,12-48, 12-72 hours
measure: AUC of the NRS-R pain intensity scores.
timeFrame: 0-12, 12-24,12-48, 12-72, 0-72 hours
measure: Proportion of subjects who used no rescue opioid analgesic.
timeFrame: 0-24, 24-48, 48-72, 0-72 hours
measure: Total rescue analgesic consumption.
timeFrame: 0-24, 24-48, 48-72, 0-72 hours
measure: Time to the first postoperative use of rescue opioid analgesics.
timeFrame: 0-72 hours
measure: Subjects' satisfaction rating
timeFrame: 72 hours
measure: Investigators' satisfaction rating
timeFrame: 72 hours
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References: