A Study of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

294 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-21

Study Completion Date

2023-10-30

Brief Summary

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

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Detailed Description

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Conditions

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Postsurgical Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

HR18034 compared with active comparator and placebo

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HR18034

Group Type EXPERIMENTAL

HR18034

Intervention Type DRUG

HR18034 380mg

ropivacaine HCl

Group Type ACTIVE_COMPARATOR

ropivacaine HCl

Intervention Type DRUG

ropivacaine HCl 75mg.

Sodium Chloride Physiological Solution

Group Type PLACEBO_COMPARATOR

Sodium Chloride Physiological Solution

Intervention Type DRUG

Sodium Chloride Physiological Solution 20ml

Interventions

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HR18034

HR18034 380mg

Intervention Type DRUG

ropivacaine HCl

ropivacaine HCl 75mg.

Intervention Type DRUG

Sodium Chloride Physiological Solution

Sodium Chloride Physiological Solution 20ml

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No