- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07722234
Clinical Practice of Hydromorphone in Multimodal Analgesia for Enhanced Recovery After Surgery (ERAS) in Knee Arthroplasty
July 20, 2026 updated by: Li Zhao, China-Japan Friendship Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China, 100029
- China-Japan Friendship Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control Group (Group R)
Ultrasound-guided single-shot adductor canal block (ACB) with 20 mL of 0.5% ropivacaine
|
Ultrasound-guided single-shot adductor canal block (ACB) with 20 mL of 0.5% ropivacaine
|
|
Experimental: Experimental Group (Group RH)
Ultrasound-guided single-shot ACB with a 20 mL mixture of 0.5% ropivacaine and 0.5 mg hydromorphone
|
Ultrasound-guided single-shot ACB with a 20 mL mixture of 0.5% ropivacaine and 0.5 mg hydromorphone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VAS score
Time Frame: Preoperatively and at 4, 8, 12, and 24 hours postoperatively
|
The co-primary outcomes were the resting and movement (active, 45° knee flexion) VAS scores (0-10) at 4, 8, 12, and 24 h after surgery, each referenced to a pre-operative baseline score.
|
Preoperatively and at 4, 8, 12, and 24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quadriceps strength
Time Frame: Preoperatively and at 4, 8, 12, and 24 hours postoperatively
|
Secondary outcomes were quadriceps strength (Lovett scale, 0-5) before surgery and at 4, 8, 12, and 24 hours after surgery.
|
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
|
At 4, 8, 12, and 24 hours postoperatively
|
|
|
Postoperative opioid use
Time Frame: At 4, 8, 12, and 24 hours postoperatively
|
At 4, 8, 12, and 24 hours postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 10, 2026
Primary Completion (Actual)
June 10, 2026
Study Completion (Actual)
June 13, 2026
Study Registration Dates
First Submitted
July 20, 2026
First Submitted That Met QC Criteria
July 20, 2026
First Posted (Actual)
July 23, 2026
Study Record Updates
Last Update Posted (Actual)
July 23, 2026
Last Update Submitted That Met QC Criteria
July 20, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Organic Chemicals
- Heterocyclic Compounds
- Heterocyclic Compounds, Fused-Ring
- Alkaloids
- Polycyclic Aromatic Hydrocarbons
- Polycyclic Compounds
- Anilides
- Amides
- Aniline Compounds
- Amines
- Heterocyclic Compounds, 4 or More Rings
- Morphinans
- Opiate Alkaloids
- Heterocyclic Compounds, Bridged-Ring
- Phenanthrenes
- Morphine Derivatives
- Ropivacaine
- Hydromorphone
Other Study ID Numbers
- CXPJJH123001-2326 (Other Grant/Funding Number: Hubei Chen Xiaoping Science and Technology Development Foundation)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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