A Study of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy

Postsurgical Pain Management Clinical Trial

Official title:

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Active and Placebo Controlled Study to Evaluate the Efficacy and Safety of Local Administration of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05769855
• Other study ID #: HR18034-301
• Status: Completed
• Phase: Phase 3
• Start date: March 21, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: February 2023
• Source: Shanghai Hengrui Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is being conducted to evaluate the efficacy, and safety of HR18034 for postoperative analgesia in subjects undergoing hemorrhoidectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Able and willing to provide a written informed consent

2. Subjects requiring hemorrhoidectomy under subarachnoid anesthesia

3. 18 kg/m2 = BMI = 30 kg/m2

4. Conform to the ASA Physical Status Classification

5. Women of childbearing age have a negative pregnancy test and are not nursing

Exclusion Criteria:

1. Subjects with a history of myocardial infarction or unstable angina pectoris

2. Subjects with atrioventricular block or cardiac insufficiency

3. Subjects with a history of ischemic stroke or transient ischemic attack

4. Subjects with a history of mental illness and a history of cognitive impairment epilepsy

5. Subjects with concurrent painful physical condition that may affect postoperative pain assessment

6. Spinal or spinal lesions that were determined by the investigator to be unable to tolerate subarachnoid anesthesia

7. Subjects with a history of hemorrhoidectomy

8. Subjects with a history of constipation

9. Subjects with a history of perianal disease

10. Abnormal values in the laboratory

11. Subject with heart rate <50 or >100 beats per minute.

12. Subject with refractory hypertension

13. History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics, opioids, or other drugs that may used in study

14. History of prohibited drug use

15. Participants who may be affected by alcohol, or drug abstinence during the study period;

16. Participated in clinical trials of other drugs (received experimental drugs)

17. The inestigators determined that other conditions were inappropriate for participation in this clinical trial

Related Conditions & MeSH terms

• Pain, Postoperative
• Postsurgical Pain Management

Intervention

Drug:
• HR18034
HR18034 380mg
• ropivacaine HCl
ropivacaine HCl 75mg.
• Sodium Chloride Physiological Solution
Sodium Chloride Physiological Solution 20ml

Locations

Country	Name	City	State
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Hengrui Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC of Pain Intensity in rest state	Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 72 hours.	0~72 hours after administration
Secondary	Proportion of subjects with Pain Rating Scale (NPRS)=4 during dressing change		0~72 hours after administration
Secondary	Proportion of subjects with Pain Rating Scale (NPRS)=4 during defecation		0~72 hours after administration
Secondary	AUC of Pain Intensity in rest state		0~24 hours after administration
Secondary	AUC of Pain Intensity in move state		0~24 hours,0~72 hours after administration
Secondary	Proportion of subjects who doesn't recive rescue analgesic		0~72 hours after administration
Secondary	Participant's satisfaction score for analgesia treatment		72-hours
Secondary	Investigator's satisfaction score for analgesia treatment		72-hours