NCT02228759

Brief Summary

Patients scheduled to undergo total knee arthroplasty will receive motor sparing knee blocks with continuous adductor canal block along with multimodal analgesia started pre-operatively and continued into the postoperative period. The study will evaluate the feasibility of home discharge within the first 24 hours following total knee arthroplasty. We will also evaluate the pain scores in the first 5 days following the surgery, causes of delayed discharge and any adverse events.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable knee-osteoarthritis

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

First Submitted

Initial submission to the registry

August 18, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 29, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

8 months

First QC Date

August 18, 2014

Last Update Submit

March 7, 2017

Conditions

Knee Osteoarthritis

Keywords

Ambulatory home regionaladductor canal blockPostoperative paintotal knee arthroplastyHome regionalFast track arthroplasty

Outcome Measures

Primary Outcomes (1)

  • percentage of patients discharged at 23 hours based on a composite of various factors represented on a pre-determined criteria

    24 hours

Secondary Outcomes (4)

  • first 24 hour pain scores

    24 hours

  • first 96 hour pain scores

    96 hours

  • Rescue analgesic frequency

    24 hours

  • total analgesic usage in the first 24 and 96 postoperative hours

    96 hours

Study Arms (1)

Adductor canal block

EXPERIMENTAL

The study is an open label pilot study to determine the feasibility of same day discharge following total knee arthroplasty with the use of a fast track regimen employing motor sparing knee blocks. The study will be performed on 25 American Society of Anesthesiologists class (ASA) 1-2 patients satisfying the inclusion criteria and undergoing unilateral primary total knee arthroplasty. First and second patients of the day undergoing surgery between Monday to Thursday in a week will be accessed for the study.

Procedure: Adductor canal block

Interventions

Adductor canal blockPROCEDURE

All patients will recieve fast tracking with reduced fasting times, multimodal analgesia and adductor canal block

Adductor canal block

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and females of 40-70years of age
  • Scheduled to undergo unilateral primary total knee arthroplasty
  • ASA Class I, II

You may not qualify if:

  • ASA 3, 4
  • Revision surgery
  • Narcotic dependent (opioid intake morphine equivalent \> 10 mg/ day for more than 3 months)
  • Other sources of chronic pain like fibromyalgia
  • Patients with associated significant cardiac, CNS or respiratory disease (poor cardio-respiratory reserve)
  • Major conduction defects in EKG (bifascilular block, CHB); significant valvular heart disease
  • Recent MI/ Stroke/ CHF (in the past 3 months)
  • BMI\> 35
  • Obstructive sleep apnea (AHI \> 15)
  • Patients with coexisting hematological disorder or with deranged coagulation parameters.
  • Patients with pre-existing major organ dysfunction such as hepatic and renal failure.
  • Psychiatric illnesses
  • Uncontrolled diabetes mellitus
  • Lack of informed consent.
  • Allergy to any of the drugs used in the study
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital, London Health Sciences centre

London, Ontario, N6A 5A5, Canada

Location

Related Publications (1)

  • Ilfeld BM, Le LT, Meyer RS, Mariano ER, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Theriaque DW, Berry LF, Spadoni EH, Gearen PF. Ambulatory continuous femoral nerve blocks decrease time to discharge readiness after tricompartment total knee arthroplasty: a randomized, triple-masked, placebo-controlled study. Anesthesiology. 2008 Apr;108(4):703-13. doi: 10.1097/ALN.0b013e318167af46.

    PMID: 18362603BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneePain, Postoperative

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 18, 2014

First Posted

August 29, 2014

Study Start

April 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 9, 2017

Record last verified: 2017-03

Locations

CA(1)