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

Total Knee Arthroplasty Clinical Trial

— ACBSL  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04828083
• Other study ID #: 1617319
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2021
• Est. completion date: November 30, 2024

Study information

• Verified date: October 2023
• Source: Rhode Island Hospital
• Contact: Vendhan Ramanujam, M.D.
• Phone: 401-444-5172
• Email: vramanujam[@]lifespan.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 30, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee
• Total Knee Arthroplasty

Intervention

Drug:
• Lidocaine 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
• Saline IV
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

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Rhode Island Hospital

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative opioid consumption	Postoperative opioid consumption will be converted to equivalent dose of oral morphine.	24 hours
Secondary	Pain Scores	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.
Secondary	Quality of Recovery	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

External Links

•   Intravenous lidocaine for acute pain: an evidence-based clinical update