- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04828083
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
Status
Recruiting
Intervention / Treatment
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
- Name: Vendhan Ramanujam, M.D.
- Phone Number: 401-444-5172
- Email: vramanujam@lifespan.org
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- Recruiting
- Rhode Island Hospital
-
Contact:
- Vendhan Ramanujam, M.D.
- Phone Number: 401-444-5172
- Email: vramanujam@lifespan.org
-
Contact:
- Mark Kendall, M.D.
- Phone Number: 401-444-4722
- Email: mark.kendall@lifespan.org
-
-
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:
|
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:
|
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.
Sponsor
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.
General Publications
- Lewis GN, Rice DA, McNair PJ, Kluger M. Predictors of persistent pain after total knee arthroplasty: a systematic review and meta-analysis. Br J Anaesth. 2015 Apr;114(4):551-61. doi: 10.1093/bja/aeu441. Epub 2014 Dec 26.
- Grevstad U, Mathiesen O, Valentiner LS, Jaeger P, Hilsted KL, Dahl JB. Effect of adductor canal block versus femoral nerve block on quadriceps strength, mobilization, and pain after total knee arthroplasty: a randomized, blinded study. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):3-10. doi: 10.1097/AAP.0000000000000169.
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
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- 1617319
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.
Clinical Trials on Arthroplasty, Replacement, Knee
-
Fondazione Don Carlo Gnocchi OnlusCompletedArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipItaly
-
Bornholms RegionskommuneCompletedArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipDenmark
-
Central DuPage HospitalTerminatedTotal Knee Replacement | Replacement, Total Knee | Arthroplasty, Knee ReplacementUnited States
-
Campus Bio-Medico UniversityRecruitingArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipItaly
-
SCRI Development Innovations, LLCWithdrawnArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipUnited States
-
Sunnybrook Health Sciences CentreActive, not recruitingArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipCanada
-
University of British ColumbiaThe Arthritis Society, Canada; Centre for Aging SMART; Centre for Advancing Health...Not yet recruitingArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipCanada
-
University Hospital, Strasbourg, FranceRecruitingArthroplasty, Hip Replacement | Arthroplasty, Knee ReplacementFrance
-
Henry Ford Health SystemConsumer Sleep SolutionsNot yet recruitingArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipUnited States
-
Haute Ecole de Santé VaudCompletedArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipSwitzerland
Clinical Trials on Saline IV
-
University of CalgaryNot yet recruitingPostural Orthostatic Tachycardia Syndrome | Post Acute Sequelae of SARS CoV 2 Infection
-
Tel-Aviv Sourasky Medical CenterUnknown
-
Healeon Medical IncTerry, Glenn C., M.D.Enrolling by invitationLung DiseaseUnited States, Honduras
-
Bayside HealthNational Health and Medical Research Council, Australia; Monash University; Cystic...UnknownCystic FibrosisAustralia
-
Healeon Medical IncTerry, Glenn C., M.D.Enrolling by invitationInflammatory Bowel DiseasesUnited States
-
Healeon Medical IncWithdrawnFibromyalgia | RSD (Reflex Sympathetic Dystrophy) | CRPS - Complex Regional Pain Syndrome Type IUnited States, Honduras
-
Healeon Medical IncRobert W. Alexander, MDSuspendedRespiratory Insufficiency | COPDUnited States, Honduras
-
Intellia TherapeuticsActive, not recruitingHereditary AngioedemaFrance, New Zealand, Germany, United Kingdom, Netherlands, Australia
-
Eli Lilly and CompanyCompletedAlzheimer's DiseaseUnited States
-
Weill Medical College of Cornell UniversitySwedish Orphan BiovitrumWithdrawnCovid19 | Mechanical Ventilation Complication | Cytokine StormUnited States