A Study of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy

NCT05769855 | Completed Phase 3

• 1 other identifier: HR18034-301
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postsurgical Pain Management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (3)

HR18034

EXPERIMENTAL

Drug: HR18034

ropivacaine HCl

ACTIVE COMPARATOR

Drug: ropivacaine HCl

Sodium Chloride Physiological Solution

PLACEBO COMPARATOR

Drug: Sodium Chloride Physiological Solution

Interventions

HR18034 DRUG

HR18034 380mg

HR18034

ropivacaine HCl DRUG

ropivacaine HCl 75mg.

ropivacaine HCl

Sodium Chloride Physiological Solution DRUG

Sodium Chloride Physiological Solution 20ml

Sodium Chloride Physiological Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide a written informed consent
• Subjects requiring hemorrhoidectomy under subarachnoid anesthesia
• kg/m2 ≤ BMI ≤ 30 kg/m2
• Conform to the ASA Physical Status Classification
• Women of childbearing age have a negative pregnancy test and are not nursing

You may not qualify if:

• Subjects with a history of myocardial infarction or unstable angina pectoris
• Subjects with atrioventricular block or cardiac insufficiency
• Subjects with a history of ischemic stroke or transient ischemic attack
• Subjects with a history of mental illness and a history of cognitive impairment epilepsy
• Subjects with concurrent painful physical condition that may affect postoperative pain assessment
• Spinal or spinal lesions that were determined by the investigator to be unable to tolerate subarachnoid anesthesia
• Subjects with a history of hemorrhoidectomy
• Subjects with a history of constipation
• Subjects with a history of perianal disease
• Abnormal values in the laboratory
• Subject with heart rate \<50 or \>100 beats per minute.
• Subject with refractory hypertension
• History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics, opioids, or other drugs that may used in study
• History of prohibited drug use
• Participants who may be affected by alcohol, or drug abstinence during the study period;

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: HR18034 compared with active comparator and placebo

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 15, 2023
• Study Start: March 21, 2023
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: March 7, 2024

Record last verified: 2023-02

Locations

CN (1)