Phase Ⅱ Study of Intercostal Nerve Block With HR18034 for Postsurgical Pain Management

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05744674
• Collaborator: (none)
• Enrollment: 96
• Arms: 2
• Anticipated Duration (Months): 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thoracoscopic Lobectomy	Drug: HR18034; Drug: Ropivacaine Hydrochloride Injection	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: HR18034 compared with active comparatorHR18034 compared with active comparator
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• 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
• Anticipated Study Start Date: Mar 30, 2023
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HR18034	Drug: HR18034; HR18034 228mg/342mg/456mg
Active Comparator: Ropivacaine Hydrochloride Injection	Drug: Ropivacaine Hydrochloride Injection; Ropivacaine Hydrochloride Injection 60mg/90mg/120mg

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. Subjects' satisfaction rating [72 hours]

   Subjects' satisfaction rating with postsurgical pain control at 72 hours.

7. Investigators' satisfaction rating [72 hours]

   Investigators' satisfaction rating with postsurgical pain control at 72 hours.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Hengrui Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05744674
• Other Study ID Numbers: HR18034-203
• First Posted: Feb 27, 2023
• Last Update Posted: Feb 27, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Ropivacaine

Study Results

No Results Posted as of Feb 27, 2023