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OpenTrials
Completed

NCT Number: NCT05376904

A Trial 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China

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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 ≤ 28 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
  • Subjects with myelopathy or spinal disease
  • Subjects with a history of hemorrhoidectomy
  • Abnormal values in the laboratory
  • Subject with a history of substance abuse and drug abuse
  • 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 substance abuse, drug use and/or alcohol abuse
  • HBsAg, HCVAb, HIV antibody and syphilis antibody tested positive during screening 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 low dose

ropivacaine HCl.

Drug

ropivacaine HCl.

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. AUC of Pain Intensity in rest state

    Time frame: 0~24 hours,0~48 hours after administration

    AUC of Pain Intensity in rest state

  2. AUC of Pain Intensity in move state

    Time frame: 0~24 hours,0~48 hours,0~72 hours after administration

    AUC of Pain Intensity in move state

  3. Pain intensity in rest state assessed using an 11-point NPRS ranging

    Time frame: 0~72 hours after administration

    11-point NPRS ranging from a score of 0 to 10

  4. Pain intensity in move state assessed using an 11-point NPRS ranging

    Time frame: 0~72 hours after administration

    11-point NPRS ranging from a score of 0 to 10

  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 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 17, 2022
Registry last updated
Mar 20, 2023

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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