A Study of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy

Phase 3

Completed

• Conditions: Postsurgical Pain Management
• Interventions: Drug: Sodium Chloride Physiological Solution; Drug: HR18034; Drug: ropivacaine HCl

• Registration Number: NCT05769855
• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-03-14
• Study First Posted: 2023-03-15
• Study Start: 2023-03-21
• Primary Completion: 2023-10-30
• Study Completion: 2023-10-30
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 294

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium Chloride Physiological Solution	Sodium Chloride Physiological Solution	-
HR18034	HR18034	-
ropivacaine HCl	ropivacaine HCl	-

Primary Outcome Measures

Name	Time	Method
AUC of Pain Intensity in rest state	0~72 hours after administration	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.

Secondary Outcome Measures

Name	Time	Method
Participant's satisfaction score for analgesia treatment	72-hours
Proportion of subjects with Pain Rating Scale (NPRS)≥4 during dressing change	0~72 hours after administration
Proportion of subjects with Pain Rating Scale (NPRS)≥4 during defecation	0~72 hours after administration
AUC of Pain Intensity in rest state	0~24 hours after administration
AUC of Pain Intensity in move state	0~24 hours，0~72 hours after administration
Proportion of subjects who doesn't recive rescue analgesic	0~72 hours after administration
Investigator's satisfaction score for analgesia treatment	72-hours

Trial Locations

Locations (1)

The Third Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China