NCT02415465

Brief Summary

Purpose: Compare continuous adductor canal block (CACB) to Combined Spinal Epidural (CSE) for total knee arthroplasty in terms of mobility, post-operative pain, and analgesic use. Hypothesis: CACB will provide better mobility than CSE post operatively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
157

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 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

January 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 14, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 15, 2016

Status Verified

April 1, 2016

Enrollment Period

1.2 years

First QC Date

April 6, 2015

Last Update Submit

April 14, 2016

Conditions

Arthroplasty

Keywords

KneeReplacement

Outcome Measures

Primary Outcomes (1)

  • Ambulation Distance in feet

    Patient ambulation distance will be measured daily after surgery until discharge from hospital

    daily after surgery until discharge from hospital, expected average up to 5 days

Secondary Outcomes (5)

  • Straight Leg Raise

    daily after surgery until discharge from hospital, expected average up to 5 days

  • Quadriceps strength

    daily after surgery until discharge from hospital, expected average up to 5 days

  • Pain as measured by numeric pain score

    daily after surgery until discharge from hospital, expected average up to 5 days

  • Post-operative inpatient opioid consumption (morphine equivalents)

    daily after surgery until discharge from hospital, expected average up to 5 days

  • Surgery Complications and Adverse Events during inpatient stay

    daily after surgery until discahrge from hospital, expected average up to 5 days

Study Arms (3)

Combined Spinal Epidural

ACTIVE COMPARATOR

Spinal Intraoperative Anesthesia with standard Epidural (0.1% bupivacaine with fentanyl 5 mcg/mL running at 6mL/hr with 1mL q15 bolus) with standard post-operative analgesics.

Procedure: EpiduralProcedure: Spinal

General+Continuous Adductor Canal Block

ACTIVE COMPARATOR

General Intraoperative Anesthesia with standard post-operative Continuous Adductor Canal Block (0.2% ropivacaine running at 6-8mL/hr) with standard post-operative analgesics.

Procedure: Continuous Adductor Canal BlockProcedure: General

Spinal+Continuous Adductor Canal Block

ACTIVE COMPARATOR

Spinal Intraoperative Anesthesia with standard post-operative Continuous Adductor Canal Block (0.2% ropivacaine running at 6-8mL/hr) with standard post-operative analgesics.

Procedure: Continuous Adductor Canal BlockProcedure: Spinal

Interventions

Continuous Adductor Canal BlockPROCEDURE

Continuous Adductor Canal Block (0.2% ropivacaine running at 6-8mL/hr)

General+Continuous Adductor Canal BlockSpinal+Continuous Adductor Canal Block
GeneralPROCEDURE

General Intraoperative Anesthesia

General+Continuous Adductor Canal Block
EpiduralPROCEDURE

Epidural (0.1% bupivacaine with fentanyl 5 mcg/mL running at 6mL/hr with 1mL q15 bolus)

Combined Spinal Epidural
SpinalPROCEDURE

Spinal Intraoperative Anesthesia

Combined Spinal EpiduralSpinal+Continuous Adductor Canal Block

Eligibility Criteria

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

You may qualify if:

  • Any patient scheduled for a primary unilateral TKA.

You may not qualify if:

  • Partial knee replacement,
  • chronic opioid use,
  • history of alcohol or drug abuse,
  • preexisting neuropathy in operative limb,
  • allergy to local anesthetics,
  • ASA Class \>3,
  • patients who decline to participate,
  • BMI \>40,
  • sleep apnea.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Interventions

Injections, Epidural

Intervention Hierarchy (Ancestors)

Injections, SpinalInjectionsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Craig J Della Valle, MD

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 6, 2015

First Posted

April 14, 2015

Study Start

January 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

April 15, 2016

Record last verified: 2016-04

Locations

US(1)