NCT04828083

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2021

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2024

Completed
Last Updated

March 10, 2026

Status Verified

July 1, 2024

Enrollment Period

3.5 years

First QC Date

March 8, 2021

Last Update Submit

March 6, 2026

Conditions

Total Knee ArthroplastyArthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

  • Postoperative opioid consumption

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

    24 hours

Secondary Outcomes (2)

  • Pain Scores

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

  • Quality of Recovery

    24 hours

Study Arms (2)

Ultrasound-guided adductor canal block with local anesthetic

ACTIVE COMPARATOR

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

Drug: Saline IV

Ultrasound-guided adductor canal block with saline

SHAM COMPARATOR

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

Drug: Lidocaine IV

Interventions

Lidocaine IVDRUG

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
Ultrasound-guided adductor canal block with saline
Saline IVDRUG

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
Ultrasound-guided adductor canal block with local anesthetic

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (2)

  • 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.

    PMID: 25542191BACKGROUND

  • 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.

    PMID: 25376972BACKGROUND

Related Links

MeSH Terms

Interventions

LidocaineSodium Chloride

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Vendhan Ramanujam, M.D.

    Rhode Island Hospital, Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2021

First Posted

April 1, 2021

Study Start

March 1, 2021

Primary Completion

August 30, 2024

Study Completion

September 2, 2024

Last Updated

March 10, 2026

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)