Total Knee ArthroplastyPhase 2NCT05561309
Phase Ⅱ Study of Adductor Canal Block With HR18034 for Postsurgical Pain Management
A Phase 2 study testing HR18034;Ropivacaine Hydrochloride Injection in people with Total Knee Arthroplasty, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
Phase Ⅱ, randomized, double-blind, comparator-controlled study to evaluate the efficacy, safety and pharmacokinetics of single injection adductor canal block with HR18034 for postoperative pain management compared with ropivacaine. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- HR18034;Ropivacaine Hydrochloride Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2022to Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide a written informed consent
- Scheduled to undergo primary unilateral total knee arthroplasty under general anesthesia.
- Male or female，aged 18-75 years inclusive
- Body mass index (BMI) 18-28 kg/m2 inclusive
- American Society of Anesthesiologists (ASA) Physical Status Classification Ⅰ~Ⅱ
Who cannot join
- Subjects with deformity of the involving operative limb, or other neuropathy
- Subjects with a history of new myocardial infarction or unstable angina within 6 months prior to randomization;
- Subjects with a history of ischemic stroke or transient ischemic attack (TIA)
- Subjects with a history of mental system diseases and cognitive dysfunction
- Combination of other pain conditions that may affect postoperative pain assessment
- Persistent or recurrent nausea and/or vomiting due to other etiologies, including, but not limited to gastric outlet obstruction, hypercalcemia, or active peptic ulcer
Show all 16Show fewer
- Subjects with a history of deep vein thrombosis-related disease
- Clinically significant abnormal clinical laboratory test value
- Allergic to a drug ingredient or component
- Use of any of medications, which affect drug metabolism or analgesia evaluation, within 5 half-lives or as specified prior to the study surgical procedure
- History of alcohol abuse or prescription and/or illicit drug abuse
- Subjects with special diets (including tobacco, grapefruit and caffeine)
- Pregnant or nursing women
- No birth control during the specified period of time
- Participated in clinical trials of other drugs (received experimental drugs)
- The inestigators determined that other conditions were inappropriate for participation in this clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ⅱ Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Single Injection Adductor Canal Block With HR18034 for Postoperative Pain Management
Phase Ⅱ, randomized, double-blind, comparator-controlled study to evaluate the efficacy, safety and pharmacokinetics of single injection adductor canal block with HR18034 for postoperative pain management compared with ropivacaine.
- Conditions
- Total Knee Arthroplasty
- Being tested
- HR18034;Ropivacaine Hydrochloride Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR18034;Ropivacaine Hydrochloride InjectionDrug
Drug: HR18034
Drug: Ropivacaine Hydrochloride Injection
Local nerve block of Ropivacaine Hydrochloride Injection to produce anesthesia for surgery and analgesia in postoperative pain management.
Other Name: Ropivacaine Hydrochloride Injection, 0.5% Injectable Solution
| Study group | Role | What they receive |
|---|---|---|
| dose 1 | Experimental | Experimental: HR18034 190mg (10ml)
Intervention: Drug: HR18034
Active Comparator: Ropivacaine Hydrochloride Injection
Ropivacaine Hydrochloride Injection 50mg (10mL)
Intervention: Drug: Ropivacaine Hydrochloride Injection Receives: Drug: HR18034;Ropivacaine Hydrochloride Injection |
| dose 2 | Experimental | Experimental: HR18034 285mg (15ml)
Intervention: Drug: HR18034
Active Comparator: Ropivacaine Hydrochloride Injection
Ropivacaine Hydrochloride Injection 75mg (15mL)
Intervention: Drug: Ropivacaine Hydrochloride Injection Receives: Drug: HR18034;Ropivacaine Hydrochloride Injection |
| dose 3 | Experimental | Experimental:HR18034 380mg (20ml)
Intervention: Drug: HR18034
Active Comparator: Ropivacaine Hydrochloride Injection
Ropivacaine Hydrochloride Injection 100mg (20mL)
Intervention: Drug: Ropivacaine Hydrochloride Injection Receives: Drug: HR18034;Ropivacaine Hydrochloride Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-72 of the NRS-R pain intensity scores.
AUC of NRS pain intensity scores at rest (NRS-R) through 72 hours after the beginning of study drug administration.
Measured: 0 to 72 hours
Secondary outcomes (9)
AUC of the NRS-R pain intensity scores.
AUC of NRS pain intensity scores at rest (NRS-R) for time periods 0-24, 0-48 hours.
Measured: 0-24, 0-48 hours
AUC of the NRS-A pain intensity scores.
AUC of NRS pain intensity scores at activity (NRS-A) for time periods 0-24, 0-48, 0-72 hours.
Measured: 0-24, 0-48, 0-72 hours
Pain intensity assessed using an 11-point NRS ranging.
11-point Numercal Rating Scale ranging from a score of 0 to 10. Pain-free defined as an NRS of 0 or 1. Worst imaginable pain defined as an NRS of 10
Measured: Baseline till 72 hours after the beginning of study drug administration
Proportion of subjects who used no rescue opioid analgesic.
Proportion of subjects who used no rescue opioid analgesic through 0-24, 24-48, 48-72 and 0-72 hours after the beginning of study drug administration.
Measured: 0-24, 24-48, 48-72, 0-72 hours
Total rescue analgesic consumption.
Total rescue analgesic consumption through 0-24, 24-48, 48-72 and 0-72 hours after the beginning of study drug administration.
Measured: 0-24, 24-48, 48-72, 0-72 hours
Time to the first postoperative use of rescue opioid analgesics.
Time to the first postoperative use of rescue opioid analgesics 0-72 hours after the beginning of study drug administration.
Measured: 0-72hours
Quadriceps muscle strength score.
Quadriceps muscle strength score at 6, 8, 12, 16, 20, 24, 36, 48 and 72 hours.
Measured: Baseline till 72 hours after the beginning of study drug administration
Subjects' satisfaction rating
Subjects' satisfaction rating with postsurgical pain control at 72 hours.
Measured: 72 hours
Investigators' satisfaction rating
Investigators' satisfaction rating with postsurgical pain control at 72 hours.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start20 Oct 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Shanghai Hengrui Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- HR18034 compared with active comparator
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561309
- Sponsor's protocol ID
- HR18034-201
- Status last verified
- Mar 2024
- First submitted
- 27 Sep 2022
- Last updated
- 4 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅱ Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Single Injection Adductor Canal Block With HR18034 for Postoperative Pain Management
- ClinicalTrials.gov ID
- NCT05561309
- Acronym / sponsor ID
- HR18034-201
- Conditions
- Total Knee Arthroplasty
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 30 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase Ⅱ, randomized, double-blind, comparator-controlled study to evaluate the efficacy, safety and pharmacokinetics of single injection adductor canal block with HR18034 for postoperative pain management compared with ropivacaine.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- HR18034 compared with active comparator
| Arm | Type | Receives |
|---|---|---|
| dose 1 | Experimental | Drug: HR18034;Ropivacaine Hydrochloride InjectionExperimental: HR18034 190mg (10ml) Intervention: Drug: HR18034 Active Comparator: Ropivacaine Hydrochloride Injection Ropivacaine Hydrochloride Injection 50mg (10mL) Intervention: Drug: Ropivacaine Hydrochloride Injection |
| dose 2 | Experimental | Drug: HR18034;Ropivacaine Hydrochloride InjectionExperimental: HR18034 285mg (15ml) Intervention: Drug: HR18034 Active Comparator: Ropivacaine Hydrochloride Injection Ropivacaine Hydrochloride Injection 75mg (15mL) Intervention: Drug: Ropivacaine Hydrochloride Injection |
| dose 3 | Experimental | Drug: HR18034;Ropivacaine Hydrochloride InjectionExperimental:HR18034 380mg (20ml) Intervention: Drug: HR18034 Active Comparator: Ropivacaine Hydrochloride Injection Ropivacaine Hydrochloride Injection 100mg (20mL) Intervention: Drug: Ropivacaine Hydrochloride Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able and willing to provide a written informed consent
- Scheduled to undergo primary unilateral total knee arthroplasty under general anesthesia.
- Male or female，aged 18-75 years inclusive
- Body mass index (BMI) 18-28 kg/m2 inclusive
- American Society of Anesthesiologists (ASA) Physical Status Classification Ⅰ~Ⅱ
Key exclusion criteria (16 listed)
- Subjects with deformity of the involving operative limb, or other neuropathy
- Subjects with a history of new myocardial infarction or unstable angina within 6 months prior to randomization;
- Subjects with a history of ischemic stroke or transient ischemic attack (TIA)
- Subjects with a history of mental system diseases and cognitive dysfunction
- Combination of other pain conditions that may affect postoperative pain assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HR18034;Ropivacaine Hydrochloride InjectionDrug: HR18034 Drug: Ropivacaine Hydrochloride Injection Local nerve block of Ropivacaine Hydrochloride Injection to produce anesthesia for surgery and analgesia in postoperative pain management. Other Name: Ropivacaine Hydrochloride Injection, 0.5% Injectable Solution | Drug | dose 1, dose 2, dose 3 |
Primary outcome
AUC0-72 of the NRS-R pain intensity scores.
Time frame: 0 to 72 hours
AUC of NRS pain intensity scores at rest (NRS-R) through 72 hours after the beginning of study drug administration.
9 secondary outcomes
AUC of the NRS-R pain intensity scores.
Time frame: 0-24, 0-48 hours
AUC of the NRS-A pain intensity scores.
Time frame: 0-24, 0-48, 0-72 hours
Pain intensity assessed using an 11-point NRS ranging.
Time frame: Baseline till 72 hours after the beginning of study drug administration
Proportion of subjects who used no rescue opioid analgesic.
Time frame: 0-24, 24-48, 48-72, 0-72 hours
Total rescue analgesic consumption.
Time frame: 0-24, 24-48, 48-72, 0-72 hours
Time to the first postoperative use of rescue opioid analgesics.
Time frame: 0-72hours
Quadriceps muscle strength score.
Time frame: Baseline till 72 hours after the beginning of study drug administration
Subjects' satisfaction rating
Time frame: 72 hours
Investigators' satisfaction rating
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Total Knee Arthroplasty
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HR18034;Ropivacaine Hydrochloride Injection in people with Total Knee Arthroplasty, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-72 of the NRS-R pain intensity scores. (time frame: 0 to 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.