NCT07722234

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2026

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 20, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
Last Updated

July 27, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

July 20, 2026

Last Update Submit

July 24, 2026

Conditions

VAS ScoreQuadriceps Strength

Keywords

Total knee arthroplastyAdductor canal blockHydromorphoneRopivacaineMultimodal AnalgesiaPostoperative analgesia

Outcome Measures

Primary Outcomes (1)

  • 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.

    Preoperatively and at 4, 8, 12, and 24 hours postoperatively

Secondary Outcomes (3)

  • Quadriceps strength

    Preoperatively and at 4, 8, 12, and 24 hours postoperatively

  • Postoperative analgesia-related adverse reactions

    At 4, 8, 12, and 24 hours postoperatively

  • Postoperative opioid use

    At 4, 8, 12, and 24 hours postoperatively

Study Arms (2)

Control Group (Group R)

PLACEBO COMPARATOR

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

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

Drug: HydromorphoneDrug: Ropivacaine

Interventions

RopivacaineDRUG

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

Control Group (Group R)Experimental Group (Group RH)
HydromorphoneDRUG

Ultrasound-guided single-shot ACB with 0.5 mg hydromorphone

Experimental Group (Group RH)

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Interventions

HydromorphoneRopivacaine

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 20, 2026

First Posted

July 23, 2026

Study Start

March 10, 2026

Primary Completion

June 10, 2026

Study Completion

June 13, 2026

Last Updated

July 27, 2026

Record last verified: 2026-07

Locations

CN(1)