NCT05769855CompletedPhase 3
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
Shanghai Hengrui Pharmaceutical Co., Ltd.1 site in 1 country294 target enrollmentStarted: March 21, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 294
- Locations
- 1
- Primary Endpoint
- AUC of Pain Intensity in rest state
Study Overview
Brief Summary
The study is being conducted to evaluate the efficacy, and safety of HR18034 for postoperative analgesia in subjects undergoing hemorrhoidectomy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
HR18034
Experimental
Intervention: HR18034 (Drug)
ropivacaine HCl
Active Comparator
Intervention: ropivacaine HCl (Drug)
Sodium Chloride Physiological Solution
Placebo Comparator
Intervention: Sodium Chloride Physiological Solution (Drug)
Outcomes
Primary Outcomes
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
- Investigator's satisfaction score for analgesia treatment(72-hours)
- Participant's satisfaction score for analgesia treatment(72-hours)
- 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)
Investigators
Study Sites (1)
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