search
Back to results

Ultrasound-guided Adductor Canal Block for Total Knee Replacement

Primary Purpose

Complications; Arthroplasty, Knee Injuries

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Preservative free normal saline
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complications; Arthroplasty

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants 40 to 75 years old who are presenting for minimally invasive total knee arthroplasty under spinal anesthesia

Exclusion Criteria:

  • Patient refusal
  • American Society of Anesthesiologists physical status classification of 4 or higher
  • Pre-existing neuropathy in the femoral or sciatic distribution
  • Coagulopathy
  • Infection at the site
  • Chronic opioid use (greater than 3 months)
  • Pregnancy
  • Medical conditions limiting physical therapy participation
  • Any other contra-indication to regional anesthesia

Sites / Locations

  • Northwestern University Feinberg School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active Group

Control Group

Arm Description

Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine

Ultrasound-guided sham block with 10 ml of preservative free normal saline

Outcomes

Primary Outcome Measures

Opioid Consumption (mg morEq)
Opioid consumption (morphine equivalents)

Secondary Outcome Measures

Visual Analog Scale Pain Score
Visual Analog Scale pain score; 0 = no pain, 10 = excruciating pain) in the knee recorded every 6 hours up to 36hrs following surgery.
Length of Hospitalization
The average time to discharge in hours. Participants were discharged home went physical therapy criteria were met.

Full Information

First Posted
March 25, 2014
Last Updated
June 14, 2017
Sponsor
Northwestern University
search

1. Study Identification

Unique Protocol Identification Number
NCT02100579
Brief Title
Ultrasound-guided Adductor Canal Block for Total Knee Replacement
Official Title
Ultrasound-guided Adductor Canal Block for Total Knee Replacement: a Randomized, Double-blind Placebo Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Total knee arthroplasty is associated with intense early postoperative pain. Fast track recovery programs including early therapy protocols and early hospital discharge are being implemented at various hospitals. The postoperative analgesic pain regimen should enhance functional recovery in addition to providing efficient analgesia with minimal side effects. Adductor canal blockade is commonly used to provide postoperative analgesia for total knee arthroplasty (TKA) surgery. The investigators hypothesize that an ultrasound guided adductor canal block will lower narcotic consumption and improved overall satisfaction compared to ultrasound guided sham block with normal saline (placebo) for patients undergoing minimally invasive TKA surgery.
Detailed Description
The investigators hypothesize that an ultrasound guided adductor canal block will lower narcotic consumption and improved overall satisfaction compared to ultrasound guided sham block with normal saline (placebo) for patients undergoing minimally invasive TKA surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complications; Arthroplasty, Knee Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Group
Arm Type
Active Comparator
Arm Description
Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Ultrasound-guided sham block with 10 ml of preservative free normal saline
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Sensorcaine
Intervention Description
10 ml of 0.25% bupivacaine
Intervention Type
Drug
Intervention Name(s)
Preservative free normal saline
Other Intervention Name(s)
0.9% sodium chloride
Intervention Description
10 ml of preservative free normal saline
Primary Outcome Measure Information:
Title
Opioid Consumption (mg morEq)
Description
Opioid consumption (morphine equivalents)
Time Frame
36 hours
Secondary Outcome Measure Information:
Title
Visual Analog Scale Pain Score
Description
Visual Analog Scale pain score; 0 = no pain, 10 = excruciating pain) in the knee recorded every 6 hours up to 36hrs following surgery.
Time Frame
Pain burden at 36hr
Title
Length of Hospitalization
Description
The average time to discharge in hours. Participants were discharged home went physical therapy criteria were met.
Time Frame
0 to 192 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants 40 to 75 years old who are presenting for minimally invasive total knee arthroplasty under spinal anesthesia Exclusion Criteria: Patient refusal American Society of Anesthesiologists physical status classification of 4 or higher Pre-existing neuropathy in the femoral or sciatic distribution Coagulopathy Infection at the site Chronic opioid use (greater than 3 months) Pregnancy Medical conditions limiting physical therapy participation Any other contra-indication to regional anesthesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoun Nader, MD
Organizational Affiliation
Northwestern University Feinberg School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ultrasound-guided Adductor Canal Block for Total Knee Replacement

We'll reach out to this number within 24 hrs