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Completed

NCT Number: NCT07722234

Clinical Practice of Hydromorphone in Multimodal Analgesia for Enhanced Recovery After Surgery (ERAS) in Knee Arthroplasty

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.

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Key information

Conditions

VAS Score Quadriceps Strength

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hydromorphone

Drug

Ultrasound-guided single-shot ACB with 0.5 mg hydromorphone

Ropivacaine

Drug

Ultrasound-guided single-shot adductor canal block (ACB) with 20 mL of 0.5% ropivacaine

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Postoperative analgesia-related adverse reactions

    Time frame: At 4, 8, 12, and 24 hours postoperatively

  3. Postoperative opioid use

    Time frame: At 4, 8, 12, and 24 hours postoperatively

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Official study title

Hydromorphone as an Adjuvant to Ropivacaine for Adductor Canal Block in Total Knee Arthroplasty: A Prospective, Randomized, Double-Blind, Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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