Systemic Lidocaine Versus Ultrasound-guided Adductor Canal Block for Patients Undergoing Total Knee Arthroplasty (ACBSL)

October 5, 2023 updated by: Rhode Island Hospital

The Efficacy of Systemic Lidocaine Versus Ultrasound-guided Adductor Canal Block for Patients Undergoing Total Knee Arthroplasty: a Randomized, Double-blinded, Non-inferiority Study

The investigators are evaluating the postoperative outcomes in patients undergoing total knee arthroplasty that receive either systemic lidocaine or ultrasound-guided adductor canal block as part of their anesthetic plan.

Study Overview

Detailed Description

Patients scheduled to have total knee arthroplasty will typically receive a single shot adductor canal block to serve as the primary anesthetic and as part of a multi-modal post-operative analgesic plan. The use of adductor canal block is still limited to where trained anesthesiologists in regional anesthesia are available. There are other nonopioid analgesic adjuncts, such as Lidocaine, which is is widely available and is a very commonly used local anesthetic. A major advantage of lidocaine is that it is not associated with a significant side effect profile. Intravenous lidocaine which can be administered during surgery and/or after surgery has demonstrated anti-inflammatory effects and can significantly decrease the reliance on opioid use for adequate pain management in abdominal and spine surgeries. The addition of systemic lidocaine infusion as part of a multimodal analgesia strategy to minimize opioid related side effects might prove to be a useful combination for clinicians where adductor canal blocks are not a viable option. However, the level of evidence comparing the efficacy of intravenous lidocaine versus adductor canal block to reduce postoperative opioid consumption in patients undergoing TKA is limited. We hypothesized that there will be no meaningful clinical difference between systemic lidocaine and ultrasound-guided adductor canal block in the 24-hour postoperative analgesia period.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ASA PS 1-3 patients undergoing primary, unilateral total knee arthroplasty

Exclusion Criteria:

  • ASA PS classification of 4 or greater
  • Pre-existing neuropathy
  • Coagulopathy
  • Chronic opioid consumption (>3 months)
  • Infection at the site
  • Known allergy to study medications (lidocaine)
  • High grade atrioventricular block (cardiac conduction system impairment)
  • A history of CVA/TIA
  • Currently using lidocaine patches
  • Known liver disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ultrasound-guided adductor canal block with local anesthetic
Single shot Ultrasound-guided adductor canal block with 0.5% ropivacaine 30 ml
Intravenous saline of 1.5 mg/kg bolus followed by a 1.5 mg/kg/h infusion continuing to the end of phase 1 of post anesthesia care unit
Other Names:
  • Sodium chloride
Sham Comparator: Ultrasound-guided adductor canal block with saline
Single shot Ultrasound-guided adductor canal block with 30 mL of normal saline (Sodium chloride)
Intravenous lidocaine of 1.5 mg/kg bolus followed by a 1.5 mg/kg/h infusion continuing to the end of phase 1 of post anesthesia care unit
Other Names:
  • Lidocaine Hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative opioid consumption
Time Frame: 24 hours
Postoperative opioid consumption will be converted to equivalent dose of oral morphine.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Scores
Time Frame: up to 2 hours (post anesthesia recovery unit), 6 hours, 12 hours, and 24 hours after surgery.
Patients were asked to rate their pain score during activity on a 11-point scale (0 = no pain to 10 = excruciating pain).
up to 2 hours (post anesthesia recovery unit), 6 hours, 12 hours, and 24 hours after surgery.
Quality of Recovery
Time Frame: 24 hours
The QoR-15 questionnaire has 15 questions that assess patient-reported quality of a patient's postoperative recovery using a 11-point numerical rating scale that leads to a minimum score of 0 (poor recovery) and a maximum score of 150 (excellent recovery).
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Vendhan Ramanujam, M.D., Rhode Island Hospital, Brown University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

March 8, 2021

First Submitted That Met QC Criteria

March 30, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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