Comparing Ropivacaine Adductor Canal Blockade by Surgeon Versus Anesthesiologist

Overview

The purpose of this study is to evaluate the efficacy of two methods of administering an adductor canal block (ACB) following total knee arthroplasty (TKA); intraoperative surgeon performed intra-articular adductor canal block (IACB) and anesthesiologist ultrasound guided ADC in the post-anesthesia recovery unit (PACU).

Full Title of Study: “A Randomized Controlled Trial Comparing Intraoperative Surgeon-Performed Versus Anesthesiologist-Performed Adductor Canal Blockade After Primary Total Knee Arthroplasty”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: June 2019

Interventions

  • Drug: Ropivacaine
    • For primary TKA, Ropivacaine is used in both arms, either performed intra-operatively by surgeon or post-operatively (ultrasound guided) by anesthesiologist.

Arms, Groups and Cohorts

  • Placebo Comparator: Control
    • Anesthesiologist preforms ultrasound guided adductor canal block post-operatively
  • Experimental: Intervention
    • Surgeon preforms inter-operative adductor canal block

Clinical Trial Outcome Measures

Primary Measures

  • Change in visual analog scale pain score
    • Time Frame: Up to 6 weeks post-surgery
    • The primary end point is the patients’ reported visual analogue pain score (VAS). 0-100mm scale

Secondary Measures

  • Change in range of motion
    • Time Frame: up to 6 weeks post-surgery
    • Range of motion
  • Change in timed up and go
    • Time Frame: up to 6 weeks post-surgery
    • Timed up and go
  • Change in daily opioid consumption
    • Time Frame: up to 6 weeks post-surgery
    • daily opioid consumption

Participating in This Clinical Trial

Inclusion Criteria

  • Patients undergoing unilateral primary TKA with underlying diagnosis of osteoarthritis
  • ASA I – III
  • Spinal anesthesia
  • All patients will have cemented total knee utilizing a medial parapatellar approach with posterior stabilized or cruciate retaining implants. A tourniquet will be used in all cases.
  • Patients must be between 18 and 80 years of age.
  • Active and valid email address for the participant.

Exclusion Criteria

  • Allergy to anesthetics or study analgesic medications.
  • Contraindication to regional anesthesia
  • Non-english speaking
  • ASA IV or greater
  • Renal insufficiency with Cr > 2.0 or hepatic failure
  • General or epidural anesthesia
  • Sensory/motor disorder involving the operative limb
  • Patients who consume preoperative opioids for pain control.
  • Pregnant women
  • Mentally disabled patients and patients with psychiatric disorders that would prevent them from properly understanding and evaluating an informed consent process.
  • Prisoners

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rothman Institute Orthopaedics
  • Collaborator
    • Sharpe-Strumia Research Foundation
  • Provider of Information About this Clinical Study
    • Sponsor

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