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

NCT ID: NCT04828083

Last Updated: 2024-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2024-11-30

Brief Summary

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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

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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.

Conditions

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Arthroplasty, Replacement, Knee Total Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Ultrasound-guided adductor canal block with local anesthetic

Single shot Ultrasound-guided adductor canal block with 0.5% ropivacaine 30 ml

Group Type ACTIVE_COMPARATOR

Saline IV

Intervention Type DRUG

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

Ultrasound-guided adductor canal block with saline

Single shot Ultrasound-guided adductor canal block with 30 mL of normal saline (Sodium chloride)

Group Type SHAM_COMPARATOR

Lidocaine IV

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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Lidocaine Hydrochloride Sodium chloride

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rhode Island Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vendhan Ramanujam, M.D.

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital, Brown University

Locations

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Rhode Island Hospital

Providence, Rhode Island, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Vendhan Ramanujam, M.D.

Role: CONTACT

401-444-5172

Facility Contacts

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Vendhan Ramanujam, M.D.

Role: primary

401-444-5172

Mark Kendall, M.D.

Role: backup

401-444-4722

References

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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.

Reference Type BACKGROUND
PMID: 25542191 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25376972 (View on PubMed)

Related Links

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https://doi.org/10.1093/bjaed/mkw008

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

Other Identifiers

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1617319

Identifier Type: -

Identifier Source: org_study_id

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