CClinicalTrials.gg
CompletedNCT04828083ACBSLUpdated Jun 15, 2026

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

A Phase 4 interventional study of Lidocaine IV and Saline IV in Arthroplasty, Replacement, Knee and Total Knee Arthroplasty, sponsored by Rhode Island Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by Rhode Island Hospital · Phase 4, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was Aug 2024, 2 years 1 month ago, and no results have been posted to the registry.
Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Arthroplasty, Replacement, Knee
  • Total Knee Arthroplasty
03

In context

Lead sponsor

Rhode Island Hospital is the lead sponsor of 187 studies on the registry; 37 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ASA PS 1-3 patients undergoing primary, unilateral total knee arthroplasty

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    Ultrasound-guided adductor canal block with local anesthetic

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

    Drug: Saline IV

  • Sham comparator
    Ultrasound-guided adductor canal block with saline

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

    Drug: Lidocaine IV

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

    Also known as: Lidocaine Hydrochloride

  • DrugSaline 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

    Also known as: Sodium chloride

06

What researchers measure

Primary outcomes

  1. Postoperative opioid consumption

    Postoperative opioid consumption will be converted to equivalent dose of oral morphine.

    Time frame: 24 hours

Secondary outcomes

  1. Pain Scores

    Patients were asked to rate their pain score during rest on a 11-point scale (0 = no pain to 10 = excruciating pain).

    Time frame: up to 2 hours (post anesthesia recovery unit), 6 hours, 12 hours, and 24 hours after surgery.

  2. 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).

    Time frame: 24 hours

07

Study locations

1 site
  • Rhode Island Hospital
    Providence, Rhode Island 02903, United States
08

References and documents

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. PubMed 25542191 ↗
  • 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. PubMed 25376972 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04828083
Lead sponsor
Rhode Island Hospital
Responsible party
Sponsor
First posted
Apr 1, 2021
Start date
Mar 1, 2021
Primary completion
Aug 30, 2024
Completion
Sep 2, 2024
Last update
Jun 15, 2026

Study contacts

Vendhan Ramanujam, M.D.
principal investigator · Rhode Island Hospital, Brown University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion