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Recruiting NCT06784882

Continuous Versus Single Injection Adductor Canal Blocks for Outpatient Total Knee Arthroplasty

Phase IV Interventional Acute Postoperative Pain Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: continuous peripheral nerve block with OnQ pump, single injection nerve block.
Who it may be relevant to
Registry conditions: Acute Postoperative Pain, Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Pilot Randomized Controlled Trial Assessing Pain and Opioid Outcomes Among Patients Undergoing Total Knee Arthroplasty Receiving 5-Day Outpatient Adductor Canal Continuous Versus Single Injection Blocks

Overview

This is a single-center pilot study to determine if an adductor canal continuous nerve block is superior to single injection nerve block following total knee arthroplasty. Investigators will randomize participants to either continuous nerve block or single injection nerve block for the adductor canal preoperatively. They will assess differences in pain (measured in numeric rating scale), opioid consumption, and physical therapy milestones from postoperative day 0 to 7.

Detailed description

Adductor canal blocks are standard care for postoperative analgesia following total knee arthroplasty. Adductor canal blocks involve depositing local anesthetic (ropivacaine) around the saphenous nerve at the location of the adductor canal on the ipsilateral thigh. At UCSD, the standard care is to perform single injection adductor canal blocks for research participants undergoing total knee arthroplasty prior to surgery in the preoperative waiting area.

Participants will be randomized to either: (1) single injection with ropivacaine (0.5%) of the adductor canal block AND a 5-day continuous perineural infusion of ropivacaine (0.2%) (experimental group); versus (2) single injection with ropivacaine (0.5%) of the adductor canal block and no continuous nerve block added.

Interventions

  • Device continuous peripheral nerve block with OnQ pump
    For continuous nerve blocks, the infusion pump that will be used are OnQ pumps (Avanos, Alpharetta, GA) and pre-filled with ropivacaine 0.2% and provided by UCSD's Investigational Drug Services.
  • Drug single injection nerve block
    An adductor canal single injection nerve block will be performed per standard of care. The adductor canal will be identified by ultrasound in the short-axis view. The distal aspect of the femoral triangle (and beginning of the adductor canal) will be identified distal to the mid-thigh in the ipsilateral limb. Using ultrasound guidance, a standard Tuohy block needle will be advanced through a skin wheal of lidocaine until its tip is in the hypoechoic area immediately distal saphenous nerve adjace

Primary outcome measures

  • analgesic effect of 5-day continuous nerve block of the adductor canal relative to a single inection nerve block with ropivacaine. [Time frame: 7 days]
  • opioid consumption of 5-day continuous nerve block of the adductor canal relative to a single inection nerve block with ropivacaine. [Time frame: 7 days]
Secondary outcome measures (4)
  • physical and emotional functioning of 5-day continuous nerve blocks relative to a single injection nerve blocks with ropivacaine [Time frame: 7 days]
  • improvement in physical therapy milestones of 5-day continuous nerve blocks relative to a single injection nerve blocks with ropivacaine [Time frame: 30 days]
  • 30-day pain score measured in Numeric Rating Scale [Time frame: 30 days]
  • 30-day postoperative opioid consumption [Time frame: 30 days]

Eligibility criteria

Inclusion criteria

  • Adult participants of at least 18 years of age
  • Undergoing a primary, unilateral, total knee arthroplasty
  • Planned single-injection adductor canal nerve block
  • Weight > 50 kg (to minimize the risk of local anesthetic toxicity)

Exclusion criteria

  • chronic opioid or tramadol use: daily oxycodone equivalents > 20 mg for > 4 weeks
  • neuro-muscular deficit of the surgical limb
  • moderate pain (NRS > 3) in an anatomic location other than the surgical site
  • planned hospital admission following surgery
  • history of opioid misuse
  • those who lack capacity to complete informed consent
  • inability to contact the investigators during the treatment period, and vice versa (e.g., lack of telephone access)
  • incarceration
  • pregnancy
  • allergy to amide local anesthetics

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of California, San Diego — La Jolla

Publications

  • Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the America PMID 26827847

Identifiers

NCT: NCT06784882 · 811228

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗