A Trial of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy.

A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Controlled Study to Evaluate the Efficacy and Safety of Local Administration of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy

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

Study Overview

• Status: Completed
• Conditions: Postsurgical Pain Management
• Intervention / Treatment: Drug: HR18034; Drug: HR18034; Drug: HR18034; Drug: ropivacaine HCl.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Qin Liu; Phone Number: +0518-82342973; Email: qin.liu@hengrui.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • The Second Affiliated Hospital of Anhui Medical University
  • Beijing
    • Beijing, Beijing, China, 100005
      • Beijing Tongren Hospital Affiliated to Capital Medical University
  • Guangdong
    • Dongguan, Guangdong, China, 523000
      • Dongguan People's Hospital
  • Guangxi
    • Nanning, Guangxi, China, 530000
      • Nanning Second People's Hospital
  • Guizhou
    • Guiyang, Guizhou, China, 550000
      • The Affiliated Hospital Of Guizhou Medical University
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Traditional Chinese Medicine Hospital of Hebei Province
  • Hubei
    • Shiyan, Hubei, China, 442099
      • Shiyan Taihe Hospital
  • Hunan
    • Changde, Hunan, China, 415000
      • The First People's Hospital of Changde
    • Changsha, Hunan, China, 410000
      • The Third Xiangya Hospital of Central South University
  • Jiangsu
    • Taizhou, Jiangsu, China, 225300
      • Taizhou People's Hospital
  • Liaoning
    • Dalian, Liaoning, China, 116001
      • Affiliated Zhongshan Hospital of Dalian University
    • Shenyang, Liaoning, China, 110000
      • General Hospital of Northern Theater Command
  • Shandong
    • Jinan, Shandong, China, 250000
      • Central Hospital Affiliated To Shandong First Medical University
  • Shanxi
    • Xi'An, Shanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiaotong University
    • Xi'an, Shanxi, China, 710077
      • The First Affiliated Hospital of Xi'an Medical University
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Sichuan Provincial People's Hospital
  • Zhejiang
    • Jiaxing, Zhejiang, China, 314000
      • Jiaxing Second Hospital
    • Ningbo, Zhejiang, China, 315040
      • Li Huili Hospital of Ningbo Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Subjects requiring hemorrhoidectomy under subarachnoid anesthesia
3. 18 kg/m2 ≤ BMI ≤ 28 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. Subjects with myelopathy or spinal disease
7. Subjects with a history of hemorrhoidectomy
8. Abnormal values in the laboratory
9. Subject with a history of substance abuse and drug abuse
10. Subject with refractory hypertension
11. History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics, opioids, or other drugs that may used in study
12. History of substance abuse, drug use and/or alcohol abuse
13. HBsAg, HCVAb, HIV antibody and syphilis antibody tested positive during screening period;
14. Participated in clinical trials of other drugs (received experimental drugs)
15. The inestigators determined that other conditions were inappropriate for participation in this clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HR18034 dose 1	Drug: HR18034; HR18034 low dose; Drug: HR18034; HR18034 midium dose; Drug: HR18034; HR18034 high dose
Experimental: HR18034 dose 2	Drug: HR18034; HR18034 low dose; Drug: HR18034; HR18034 midium dose; Drug: HR18034; HR18034 high dose
Experimental: HR18034 dose 3	Drug: HR18034; HR18034 low dose; Drug: HR18034; HR18034 midium dose; Drug: HR18034; HR18034 high dose
Active Comparator: ropivacaine HCl	Drug: ropivacaine HCl.; ropivacaine HCl.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC of Pain Intensity in rest state	AUC of Pain Intensity in rest state	0~24 hours，0~48 hours after administration
AUC of Pain Intensity in move state	AUC of Pain Intensity in move state	0~24 hours，0~48 hours，0~72 hours after administration
Pain intensity in rest state assessed using an 11-point NPRS ranging	11-point NPRS ranging from a score of 0 to 10	0~72 hours after administration
Pain intensity in move state assessed using an 11-point NPRS ranging	11-point NPRS ranging from a score of 0 to 10	0~72 hours after administration
Proportion of subjects who doesn't recive rescue analgesic		0~72 hours after administration
Participant's satisfaction score for analgesia treatment		72-hours
Investigator's satisfaction score for analgesia treatment		72-hours

Collaborators and Investigators

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2022
• Primary Completion (Actual): October 5, 2022
• Study Completion (Actual): October 5, 2022

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: HR18034-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No