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Completed

NCT Number: NCT05769855

A Study 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able and willing to provide a written informed consent
  • Subjects requiring hemorrhoidectomy under subarachnoid anesthesia
  • 18 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

Exclusion criteria

  • 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;
  • Participated in clinical trials of other drugs (received experimental drugs)
  • The inestigators determined that other conditions were inappropriate for participation in this clinical trial

Treatment and study plan

HR18034

Drug

HR18034 380mg

Ropivacaine HCL

Drug

ropivacaine HCl 75mg.

Sodium Chloride Physiological Solution

Drug

Sodium Chloride Physiological Solution 20ml

Primary outcomes

  1. AUC of Pain Intensity in rest state

    Time frame: 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 outcomes

  1. Proportion of subjects with Pain Rating Scale (NPRS)≥4 during dressing change

    Time frame: 0~72 hours after administration

  2. Proportion of subjects with Pain Rating Scale (NPRS)≥4 during defecation

    Time frame: 0~72 hours after administration

  3. AUC of Pain Intensity in rest state

    Time frame: 0~24 hours after administration

  4. AUC of Pain Intensity in move state

    Time frame: 0~24 hours,0~72 hours after administration

  5. Proportion of subjects who doesn't recive rescue analgesic

    Time frame: 0~72 hours after administration

  6. Participant's satisfaction score for analgesia treatment

    Time frame: 72-hours

  7. Investigator's satisfaction score for analgesia treatment

    Time frame: 72-hours

Sponsors and collaborators

Lead sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Active and Placebo Controlled Study to Evaluate the Efficacy and Safety of Local Administration of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 15, 2023
Registry last updated
Mar 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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