Postoperative Pain Management in Total Knee ArthroplastyPhase 2NCT06509958
Phase Ⅱ Study of Adductor Canal Block With HR18034 for Postsurgical Pain Management in TKA
A Phase 2 study testing HR18034 and Ropivacaine Hydrochloride Injection in people with Postoperative Pain Management in 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 in total knee arthroplasty compared with ropivacaine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain Management in Total Knee Arthroplasty
- What is being tested?
- HR18034 and Ropivacaine Hydrochloride Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2024to 10 Oct 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 years and older
- 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 years
- Body mass index (BMI) ≥ 18 kg/m2
- American Society of Anesthesiologists (ASA) Physical Status Classification Ⅰ~Ⅲ
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 15Show 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
- 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.
China1 site
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
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 in Total Knee Arthroplasty
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 in total knee arthroplasty compared with ropivacaine.
- 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.
HR18034Drug
HR18034
Ropivacaine Hydrochloride InjectionDrug
Ropivacaine Hydrochloride Injection
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 | Experimental | Not described Receives: Drug: HR18034 |
| Dose 2 | Experimental | Not described Receives: Drug: HR18034 |
| Ropivacaine Hydrochloride Injection | Active comparator | Not described Receives: Drug: Ropivacaine Hydrochloride Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-72h of the NRS-A pain intensity scores.
AUC of NRS pain intensity scores at activity (NRS-A) through 72 hours after the beginning of study drug administration.
Measured: 0 to 72 hours
Secondary outcomes (11)
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 hours.
Measured: 0-24, 0-48hours
AUC of the NRS-R pain intensity scores.
Measured: 0-24, 0-48，0-72 hours
AUC of NRS pain intensity scores at rest (NRS-R) for time periods 0-24, 0-48 ,0-72 hours.
Measured: 0-24, 0-48 ,0-72 hours.
Pain intensity assessed using an 12-point NRS ranging.
Measured: Baseline till 72 hours after the beginning of study drug administration
Proportion of subjects who used no rescue opioid analgesic.
Measured: 0-24, 24-48, 48-72, 0-72 hours
Total rescue analgesic consumption.
Measured: 0-24, 24-48, 48-72, 0-72 hours
Time to the first postoperative use of rescue opioid analgesics.
Measured: 0-72hours
Quadriceps muscle strength score.
Measured: Baseline till 72 hours after the beginning of study drug administration
Range of motion of the knee joint.
Measured: Baseline till 72 hours after the beginning of study drug administration
Subjects' satisfaction rating
Measured: 72 hours
Investigators' satisfaction rating
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 posted19 Jul 2024
- Study start20 Aug 2024
- Primary completion10 Oct 2024
- Study completion10 Oct 2024
Why it stopped: Sponsor's R\&D Strategy adjusted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain Management in 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 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
- NCT06509958
- Sponsor's protocol ID
- HR18034-204
- Status last verified
- Oct 2024
- First submitted
- 15 Jul 2024
- Last updated
- 30 Oct 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 30 Oct 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 in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06509958
- Acronym / sponsor ID
- HR18034-204
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's R\&D Strategy adjusted
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 19 Jul 2024 (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 in total knee arthroplasty compared with ropivacaine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose 1 | Experimental | Drug: HR18034 |
| Dose 2 | Experimental | Drug: HR18034 |
| Ropivacaine Hydrochloride Injection | Active comparator | Drug: Ropivacaine Hydrochloride Injection |
Who may qualify
- Ages
- 18 years and older
- 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 years
- Body mass index (BMI) ≥ 18 kg/m2
- American Society of Anesthesiologists (ASA) Physical Status Classification Ⅰ~Ⅲ
Key exclusion criteria (15 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 |
|---|---|---|
| HR18034HR18034 | Drug | Dose 1, Dose 2 |
| Ropivacaine Hydrochloride InjectionRopivacaine Hydrochloride Injection | Drug | Ropivacaine Hydrochloride Injection |
Primary outcome
AUC0-72h of the NRS-A pain intensity scores.
Time frame: 0 to 72 hours
AUC of NRS pain intensity scores at activity (NRS-A) through 72 hours after the beginning of study drug administration.
11 secondary outcomes
AUC of the NRS-A pain intensity scores.
Time frame: 0-24, 0-48hours
AUC of the NRS-R pain intensity scores.
Time frame: 0-24, 0-48，0-72 hours
AUC of NRS pain intensity scores at rest (NRS-R) for time periods 0-24, 0-48 ,0-72 hours.
Time frame: 0-24, 0-48 ,0-72 hours.
Pain intensity assessed using an 12-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
Range of motion of the knee joint.
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
The study was stopped early (reason given: Sponsor's R\&D Strategy adjusted). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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 and Ropivacaine Hydrochloride Injection in people with Postoperative Pain Management in 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 15 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: stopped early, as of the sponsor's last update on 30 Oct 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?
The study was stopped early (reason given: Sponsor's R\&D Strategy adjusted). 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?
AUC0-72h of the NRS-A 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 30 Oct 2024.