NCT07506629

Brief Summary

This study aims to compare the analgesic efficacy of surgeon-performed intraoperative adductor canal block (ACB) and ultrasound-guided anesthesiologist-performed ACB in patients undergoing bilateral total knee arthroplasty (TKA). In a prospective, randomized paired design, each patient will receive surgeon-performed ACB on one knee and anesthesiologist-performed ACB on the contralateral knee. The primary outcome is postoperative pain measured using the Numeric Rating Scale (NRS), and the study is designed to evaluate the non-inferiority of surgeon-performed ACB. Secondary outcomes include opioid consumption, time to first ambulation, length of hospital stay, postoperative complications, and patient-reported outcome measures (PROMs). Additionally, postoperative ultrasound evaluation will be performed to assess the distribution pattern of local anesthetic within the adductor canal, including cross-sectional area and longitudinal spread. This study is expected to provide evidence regarding the clinical effectiveness and technical accuracy of surgeon-performed ACB in comparison with the conventional ultrasound-guided technique.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
34mo left

Started May 2026

Typical duration for not_applicable knee-osteoarthritis

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
May 2026Mar 2029

First Submitted

Initial submission to the registry

March 26, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 1, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

2.7 years

First QC Date

March 26, 2026

Last Update Submit

March 26, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain (Numeric Rating Scale)

    Postoperative pain will be assessed using the Numeric Rating Scale (NRS, 0-10). Pain scores will be recorded at predefined time points under resting conditions. The primary analysis will evaluate the non-inferiority of surgeon-performed adductor canal block compared to ultrasound-guided adductor canal block.

    Baseline, postoperative day 0 (afternoon), postoperative day 1 (morning and afternoon), and postoperative day 2 (morning)

Study Arms (2)

Surgeon-Performed Adductor Canal Block

EXPERIMENTAL

Adductor canal block performed intraoperatively by the surgeon using an anatomical landmark-based technique. The injection is administered during surgery without ultrasound guidance using a standardized approach and the same type and volume of local anesthetic as the comparator.

Biological: Surgeon-Performed Adductor Canal Block

Ultrasound-Guided Adductor Canal Block

ACTIVE COMPARATOR

Adductor canal block performed by an anesthesiologist under ultrasound guidance using real-time imaging. The same concentration and volume of local anesthetic are administered using a standardized ultrasound-guided technique.

Biological: Ultrasound-Guided Adductor Canal Block

Interventions

An adductor canal block performed intraoperatively by the surgeon using an anatomical landmark-based technique. The injection is administered at approximately 8 cm proximal to the distal femur, with the needle directed medially and posteriorly. A total of 20 mL of 0.3% ropivacaine mixed with epinephrine is injected using a standardized approach without ultrasound guidance.

Surgeon-Performed Adductor Canal Block

An adductor canal block performed by an anesthesiologist under ultrasound guidance. The saphenous nerve and femoral artery within the adductor canal are identified using real-time imaging, and 20 mL of 0.3% ropivacaine mixed with epinephrine is injected using an in-plane technique.

Ultrasound-Guided Adductor Canal Block

Eligibility Criteria

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

You may qualify if:

  • Adult patients aged 19 years or older
  • Patients scheduled for bilateral total knee arthroplasty
  • Patients who provide written informed consent

You may not qualify if:

  • Refusal to participate or inability to provide informed consent
  • Neurological or psychiatric conditions affecting cooperation (e.g., dementia, delirium)
  • Pre-existing neurological or anatomical abnormalities of the lower extremities
  • Chronic opioid use or opioid dependence
  • Coagulation disorders or contraindications to nerve block
  • Pregnancy
  • Cases in which ultrasound evaluation is technically not feasible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, KneePain, Postoperative

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Kwan-Kyu Park, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2026

First Posted

April 1, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

March 1, 2029

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share