NCT07581886

Brief Summary

This study compares the analgesic efficacy of single-dose adductor canal block (sACB) versus continuous-dose adductor canal block (cACB) for postoperative pain management in total knee replacement patients. To ensure a high level of clinical accuracy, the investigation specifically focuses on a cACB cohort where ultrasound confirmation ensures the catheter remains correctly positioned for a full 48 hours. Participants are assigned to groups using a 1:1 randomization protocol via computer-generated tables to eliminate selection bias. Clinical consistency is maintained by using identical pharmacological agents across both groups: 0.5% Heavy Bupivacaine for spinal anesthesia and 0.5% ropivacaine with 1:200,000 epinephrine for the nerve block itself. Furthermore, both groups adhere to a standardized multimodal analgesic schedule to control for external variables. In the cACB group, intravenous patient-controlled analgesia (IV PCA) serves as a designated rescue therapy should the catheter fail. The primary technical evaluation occurs 48 hours post-surgery, utilizing ultrasound to verify catheter placement and quantify pain levels. Beyond immediate recovery, the study evaluates long-term success through Patient-Reported Outcome Measures (PROMs) at a 12-week follow-up, focusing on functional restoration and the patient's overall quality of life. By isolating the variable of catheter stability, the research aims to provide a definitive comparison of whether the continuous delivery of local anesthetic offers a statistically significant clinical advantage over a single-dose administration in the context of modern orthopedic recovery protocols.

Trial Health

65
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Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
21mo left

Started May 2026

Status
not yet recruiting

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 Progress1%
May 2026Jan 2028

First Submitted

Initial submission to the registry

May 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

May 18, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2028

Expected
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

1.6 years

First QC Date

May 6, 2026

Last Update Submit

May 6, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • postoperative pain score at rest (Area Under Curve, AUC)

    48-hour postoperative pain score at rest (Area Under Curve, AUC) using NRS.

    postoperative 48 hours

Study Arms (2)

Continuous ACB

ACTIVE COMPARATOR
Procedure: Continuous ACB

Single-shot ACB

SHAM COMPARATOR
Procedure: Single-shot ACB

Interventions

Adductor canal block, a lower extremity nerve block technique for postoperative pain control, is performed under ultrasound guidance for patients undergoing total knee arthroplasty, and is carried out by inserting a catheter. The catheter is connected to a PCA pump following insertion, with a continuous infusion rate for two days post-surgery.

Continuous ACB

Adductor canal block, a lower extremity nerve block technique for postoperative pain control, is performed under ultrasound guidance for patients undergoing total knee arthroplasty, and is carried out by a single-shot local anesthetic administration.

Single-shot ACB

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40-80 yrs
  • Scheduled for unilateral total knee arthroplatsy
  • ASA I-III
  • BMI 18-35 kg/㎡
  • Able to read and understand consent form

You may not qualify if:

  • Allergy to local anesthetics
  • Infection at the block site
  • History of neuropathy or peripheral nerve disease
  • Coagulation disorders or use of anticoagulants (if discontinuation is not possible)
  • Communication disorders or cognitive impairment
  • Chronic opioid use (≥30 MME/day, 3 months or more)
  • Severe chronic pain (NRS ≥7/10, 3 months or more)
  • Renal impairment (eGFR \<30 mL/min/1.73m²)
  • Hepatic impairment (Child-Pugh C)
  • Blood coagulation disorders
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

eunjung Kim

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2026

First Posted

May 12, 2026

Study Start

May 18, 2026

Primary Completion (Estimated)

January 10, 2028

Study Completion (Estimated)

January 31, 2028

Last Updated

May 12, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share