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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04828083
Acronym
ACBSL
Enrollment
120
Registered
2021-04-01
Start date
2021-03-01
Completion date
2024-09-02
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty, Replacement, Knee, Total Knee Arthroplasty

Brief summary

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.

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.

Interventions

DRUGLidocaine IV

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

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

Sponsors

Rhode Island Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative opioid consumption24 hoursPostoperative opioid consumption will be converted to equivalent dose of oral morphine.

Secondary

MeasureTime frameDescription
Pain Scoresup 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 rest on a 11-point scale (0 = no pain to 10 = excruciating pain).
Quality of Recovery24 hoursThe 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).

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORVendhan Ramanujam, M.D.

Rhode Island Hospital, Brown University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026