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

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:

  1. ASA physical status I-III;
  2. Undergoing elective unilateral primary total knee arthroplasty (TKA);
  3. Implementing the ERAS protocol
  4. Body-mass index (BMI) of 18.5-32.0 kg/m²;
  5. Provided written informed consent.

Exclusion Criteria:

  1. Allergy to amide local anaesthetics or opioids;
  2. Chronico or disorder opioid use;
  3. Pre-existing central and peripheral nerve injuries;
  4. Lower limb muscle weakness
  5. Unable to cooperate with VAS pain assessment
  6. 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.

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

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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