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

Postsurgical Pain Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05376904
• Other study ID #: HR18034-202
• Status: Completed
• Phase: Phase 2
• Start date: June 13, 2022
• Est. completion date: October 5, 2022

Study information

• Verified date: May 2022
• 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. To explore the reasonable dosage of HR18034 for postoperative analgesia in subjects undergoing hemorrhoidectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: October 5, 2022
• Est. primary completion date: October 5, 2022
• 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 = 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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postsurgical Pain Management

Intervention

Drug:
• HR18034
HR18034 low dose
• HR18034
HR18034 midium dose
• HR18034
HR18034 high dose
• ropivacaine HCl.
ropivacaine HCl.

Locations

Country	Name	City	State
China	Beijing Tongren Hospital Affiliated to Capital Medical University	Beijing	Beijing
China	the first People's Hospital of Changde	Changde	Hunan
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	Affiliated Zhongshan Hospital of Dalian University	Dalian	Liaoning
China	Dongguan people's Hospital	Dongguan	Guangdong
China	The Affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou
China	The Second Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	Jiaxing Second Hospital	Jiaxing	Zhejiang
China	Central Hospital Affiliated to Shandong First Medical University	Jinan	Shandong
China	Nanning Second People's Hospital	Nanning	Guangxi
China	Li Huili Hospital of Ningbo Medical Center	Ningbo	Zhejiang
China	General Hospital of Northern Theater Command	Shenyang	Liaoning
China	Traditional Chinese Medicine Hospital of Hebei Province	Shijiazhuang	Hebei
China	Shiyan Taihe Hospital	Shiyan	Hubei
China	Taizhou People's Hospital	Taizhou	Jiangsu
China	the First Affiliated Hospital of Xi'An Jiaotong University	Xi'An	Shanxi
China	The First Affiliated Hospital of Xi'an Medical University	Xi'an	Shanxi

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	AUC of Pain Intensity in rest state	AUC of Pain Intensity in rest state	0~24 hours,0~48 hours after administration
Secondary	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
Secondary	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
Secondary	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
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