Clinical trial NCT04828083: Systemic Lidocaine Versus Ultrasound-guided Adductor Canal Block for Patients Undergoing Total Knee Arthroplasty
Official title: The Efficacy of Systemic Lidocaine Versus Ultrasound-guided Adductor Canal Block for Patients Undergoing Total Knee Arthroplasty: a Randomized, Double-blinded, Non-inferiority Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Arthroplasty, Replacement, Knee
Total Knee Arthroplasty
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative opioid consumption
timeFrame: 24 hours
Secondary outcomes:
measure: Pain Scores
timeFrame: up to 2 hours (post anesthesia recovery unit), 6 hours, 12 hours, and 24 hours after surgery.
measure: Quality of Recovery
timeFrame: 24 hours
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital, Brown University
name: Vendhan Ramanujam, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.