VAS ScoreNCT07722234
Clinical Practice of Hydromorphone in Multimodal Analgesia for Enhanced Recovery After Surgery (ERAS) in Knee Arthroplasty
A study testing Hydromorphone and Ropivacaine in people with VAS Score and Quadriceps Strength, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
This study proposes a multimodal analgesia regimen comprising preoperative non-steroidal anti-inflammatory drugs (NSAIDs) for preemptive analgesia, intra-articular injection at the end of surgery, and postoperative adductor canal block. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- VAS Score, Quadriceps Strength
- What is being tested?
- Hydromorphone and Ropivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2026to 13 Jun 2026
- Phase
- Interventional
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I-III;
- Undergoing elective unilateral primary total knee arthroplasty (TKA);
- Implementing the ERAS protocol
- Body-mass index (BMI) of 18.5-32.0 kg/m²;
- Provided written informed consent.
Who cannot join
- Allergy to amide local anaesthetics or opioids;
- Chronico or disorder opioid use;
- Pre-existing central and peripheral nerve injuries；
- Lower limb muscle weakness
- Unable to cooperate with VAS pain assessment
- Contraindications for nerve block include infection at the puncture site.
Trial locations and contacts
1 site in 1 country.
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
About this study
Official title: Hydromorphone as an Adjuvant to Ropivacaine for Adductor Canal Block in Total Knee Arthroplasty: A Prospective, Randomized, Double-Blind, Controlled Trial
This study proposes a multimodal analgesia regimen comprising preoperative non-steroidal anti-inflammatory drugs (NSAIDs) for preemptive analgesia, intra-articular injection at the end of surgery, and postoperative adductor canal block. The objective is to observe the analgesic efficacy and duration of hydromorphone combined with ropivacaine in the adductor canal block on resting and movement-related pain in patients following total knee arthroplasty, as well as the time to recovery from motor blockade and the incidence of drug-related adverse events.
- Conditions
- VAS Score, Quadriceps Strength
- Being tested
- Hydromorphone, Ropivacaine
- Keywords
- Total knee arthroplasty, Adductor canal block, Hydromorphone, Ropivacaine, Multimodal Analgesia, Postoperative analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydromorphoneDrug
Ultrasound-guided single-shot ACB with 0.5 mg hydromorphone
RopivacaineDrug
Ultrasound-guided single-shot adductor canal block (ACB) with 20 mL of 0.5% ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| Control Group (Group R) | Placebo comparator | Ultrasound-guided single-shot adductor canal block (ACB) with 20 mL of 0.5% ropivacaine Receives: Drug: Ropivacaine |
| Experimental Group (Group RH) | Experimental | Ultrasound-guided single-shot ACB with a 20 mL mixture of 0.5% ropivacaine and 0.5 mg hydromorphone Receives: Drug: Hydromorphone; Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) Pain Score
The co-primary outcomes consisted of resting pain score and dynamic pain score during active 45° knee flexion measured by the Visual Analog Scale (VAS). The scale ranges from a minimum value of 0 points (no pain) to a maximum value of 10 points (the worst imaginable pain); higher scores indicate more severe pain. Assessments were conducted at baseline before surgery, and at 4 hours, 8 hours, 12 hours and 24 hours after surgery.
Measured: Preoperatively and at 4, 8, 12, and 24 hours postoperatively
Secondary outcomes (3)
Quadriceps strength
Secondary outcomes were quadriceps strength (Lovett scale, 0-5) before surgery and at 4, 8, 12, and 24 hours after surgery.
Measured: Preoperatively and at 4, 8, 12, and 24 hours postoperatively
Postoperative analgesia-related adverse reactions
Measured: At 4, 8, 12, and 24 hours postoperatively
Postoperative opioid use
Measured: At 4, 8, 12, and 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start10 Mar 2026
- Primary completion10 Jun 2026
- Study completion13 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VAS ScoreStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Zhao, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722234
- Sponsor's protocol ID
- CXPJJH123001-2326
- Other IDs
- CXPJJH123001-2326
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydromorphone as an Adjuvant to Ropivacaine for Adductor Canal Block in Total Knee Arthroplasty: A Prospective, Randomized, Double-Blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT07722234
- Acronym / sponsor ID
- CXPJJH123001-2326
- Conditions
- VAS Score, Quadriceps Strength
- Keywords
- Total knee arthroplasty, Adductor canal block, Hydromorphone, Ropivacaine, Multimodal Analgesia, Postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 10 Jun 2026 (actual)
- Study completion
- 13 Jun 2026 (actual)
- First posted
- 23 Jul 2026 (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.
This study proposes a multimodal analgesia regimen comprising preoperative non-steroidal anti-inflammatory drugs (NSAIDs) for preemptive analgesia, intra-articular injection at the end of surgery, and postoperative adductor canal block. The objective is to observe the analgesic efficacy and duration of hydromorphone combined with ropivacaine in the adductor canal block on resting and movement-related pain in patients following total knee arthroplasty, as well as the time to recovery from motor blockade and the incidence of drug-related adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group (Group R) | Placebo comparator | Drug: RopivacaineUltrasound-guided single-shot adductor canal block (ACB) with 20 mL of 0.5% ropivacaine |
| Experimental Group (Group RH) | Experimental | Drug: Hydromorphone, Drug: RopivacaineUltrasound-guided single-shot ACB with a 20 mL mixture of 0.5% ropivacaine and 0.5 mg hydromorphone |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ASA physical status I-III;
- Undergoing elective unilateral primary total knee arthroplasty (TKA);
- Implementing the ERAS protocol
- Body-mass index (BMI) of 18.5-32.0 kg/m²;
- Provided written informed consent.
Key exclusion criteria (6 listed)
- Allergy to amide local anaesthetics or opioids;
- Chronico or disorder opioid use;
- Pre-existing central and peripheral nerve injuries；
- Lower limb muscle weakness
- Unable to cooperate with VAS 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 |
|---|---|---|
| HydromorphoneUltrasound-guided single-shot ACB with 0.5 mg hydromorphone | Drug | Experimental Group (Group RH) |
| RopivacaineUltrasound-guided single-shot adductor canal block (ACB) with 20 mL of 0.5% ropivacaine | Drug | Control Group (Group R), Experimental Group (Group RH) |
Primary outcome
Visual Analog Scale (VAS) Pain Score
Time frame: Preoperatively and at 4, 8, 12, and 24 hours postoperatively
The co-primary outcomes consisted of resting pain score and dynamic pain score during active 45° knee flexion measured by the Visual Analog Scale (VAS). The scale ranges from a minimum value of 0 points (no pain) to a maximum value of 10 points (the worst imaginable pain); higher scores indicate more severe pain. Assessments were conducted at baseline before surgery, and at 4 hours, 8 hours, 12 hours and 24 hours after surgery.
3 secondary outcomes
Quadriceps strength
Time frame: Preoperatively and at 4, 8, 12, and 24 hours postoperatively
Postoperative analgesia-related adverse reactions
Time frame: At 4, 8, 12, and 24 hours postoperatively
Postoperative opioid use
Time frame: At 4, 8, 12, and 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
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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 study testing Hydromorphone and Ropivacaine in people with VAS Score and Quadriceps Strength, run by China-Japan Friendship Hospital 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 6 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: finished, as of the sponsor's last update on 27 Jul 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Analog Scale (VAS) Pain Score (time frame: Preoperatively and at 4, 8, 12, and 24 hours postoperatively). 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 27 Jul 2026.