NCT02730728

Brief Summary

The purpose of this study is to compare a single shot block, 24 hours, and 48 hour continuous catheter nerve block done via the adductor canal method in adult patients who have under gone total knee arthroplasty. Visual analogue scores, opioid consumption, time to up and go, ambulation, manual muscle tests, and Tinetti scores up to 72 hours post operatively will be used for comparison.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
159

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

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

November 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

June 18, 2018

Completed
Last Updated

October 31, 2018

Status Verified

May 1, 2018

Enrollment Period

8 months

First QC Date

March 23, 2016

Results QC Date

April 18, 2018

Last Update Submit

October 5, 2018

Conditions

Total Knee ArthroplastyOsteoarthritisPost Operative Pain Control

Keywords

adductor canal blocktinetti scoretime to up and go testAmbulation distancepain scorequality of recovery score

Outcome Measures

Primary Outcomes (1)

  • Patients With Severe Pain at 48 Hours After Surgery

    The proportion of patients reporting severe pain, defined as pain score (7-10) through the second postoperative day

    48 hours

Secondary Outcomes (3)

  • Pain Scores at 48 Hours After Surgery

    48 hours

  • Functional Recovery After Surgery

    48 hours

  • Patient-oriented Outcomes

    48 hours

Study Arms (3)

Single shot adductor canal block

ACTIVE COMPARATOR

adductor canal block group will receive single shot adductor canal block with 20ml bolus of 0.5% ropivicaine for analgesia after TKA

Drug: 20ml bolus of 0.5% ropivicaine

24 hour continuous adductor canal block

ACTIVE COMPARATOR

adductor canal block group will receive 24 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA

Drug: 0.2% Ropivicaine at 8 milliliter/hourDrug: 5ml bolus of 0.5% ropivicaine

48 hour continuous adductor canal block

ACTIVE COMPARATOR

adductor canal block group will receive 48 hour continuous adductor canal block (0.2% Ropivicaine at 8 milliliter/hour) with initial 5ml bolus of 0.5% Ropivicaine for analgesia after TKA

Drug: 0.2% Ropivicaine at 8 milliliter/hourDrug: 5ml bolus of 0.5% ropivicaine

Interventions

20ml bolus of 0.5% ropivicaineDRUG

Local anesthetic

Single shot adductor canal block
0.2% Ropivicaine at 8 milliliter/hourDRUG

Local anesthetic

24 hour continuous adductor canal block48 hour continuous adductor canal block
5ml bolus of 0.5% ropivicaineDRUG

Local anesthetic

24 hour continuous adductor canal block48 hour continuous adductor canal block

Eligibility Criteria

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

You may qualify if:

  • Patients scheduled for primary total knee arthroplasty
  • American Society of Anesthesiologists (ASA) physical status I -III
  • mentally competent and able to give consent for enrollment in the study

You may not qualify if:

  • Patient younger than 18 years old
  • Allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone, and any of the drugs included in the multimodal perioperative pain protocol (MP3)
  • Revision surgery
  • Impaired kidney functions and patient with coagulopathy
  • Chronic pain syndromes; Patients will be defined to have chronic pain if they are using regular daily doses of systemic narcotics for the past 3 months prior to the surgery
  • BMI of 40 or more
  • Pregnancy (positive urine pregnancy test result in Preop area on morning of surgery)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Dr Nabil Elkassabany
Organization
University of Pennsylvania
nabil.elkassabany@uphs.upenn.edu
2156628000

Study Officials

  • Nabil M Elkassabany, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2016

First Posted

April 6, 2016

Study Start

November 1, 2015

Primary Completion

June 30, 2016

Study Completion

January 1, 2017

Last Updated

October 31, 2018

Results First Posted

June 18, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)