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IPACK and Adductor Canal Catheter Patient Outcomes for TKAs?

Primary Purpose

Surgery, Acute Pain

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Adductor Canal Block + Catheter & IPACK block
Adductor canal block + catheter
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgery focused on measuring total knee arthroplasty, regional block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients undergoing total knee replacement without contraindications to regional blocks

Exclusion Criteria:

  • Patients who have contraindications to regional blocks: infection at injection site for the nerve block, allergy to local anesthetics, history of a bleeding disorder

Sites / Locations

  • UCLA Medical Center, Santa Monica

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Adductor Canal Block + Catheter

Adductor Canal Block + Catheter & IPACK

Arm Description

Adductor canal block: 15 mL of 0.25% ropivicaine, adductor canal catheter: 6 mL/hr of 0.2% ropivacaine

Adductor canal block: 15 mL of 0.25% ropivicaine, adductor canal catheter: 6 mL/hr of 0.2% ropivacaine, IPACK block: 15 ml of 0.25% ropivacaine.

Outcomes

Primary Outcome Measures

Opioid consumption in milligram morphine equivalents
Total opioid consumption will be calculated for postoperative day 0-3 ( postoperative day 0 is the day of the surgery and is the first day of the time frame and postoperative day 3 is the 4th day) and total hospital stay. Opioid amount will be converted to morphine equivalents (milligram) for comparison.

Secondary Outcome Measures

Visual analog pain scores
Pain scores will be assessed postoperative day 0-3 ( postoperative day 0 is the day of the surgery and is the first day of the time frame and postoperative day 3 is the 4th day) using the visual analog score (Scale 0-10). Zero for no pain and ten being the worst pain experienced. They will be obtained and recorded every 4 to 6 hours by the nurse monitoring the subject.
Distance ambulated during physical therapy
Distance (meters) ambulated during physical therapy will be recorded for postoperative day 0-3 ( postoperative day 0 is the day of the surgery and is the first day of the time frame and postoperative day 3 is the 4th day)

Full Information

First Posted
December 4, 2018
Last Updated
February 18, 2020
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT03774966
Brief Title
IPACK and Adductor Canal Catheter Patient Outcomes for TKAs?
Official Title
Do Patients Who Receive the IPACK and Adductor Canal Catheter Have Better Outcomes Than Patients Receiving the Adductor Canal Catheter Alone for Total Knee Replacements?
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 12, 2019 (Actual)
Primary Completion Date
May 28, 2019 (Actual)
Study Completion Date
May 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates the addition of the IPACK block to the adductor canal block and catheter in the pain management of total knee arthroplasty. Half of participants will receive the adductor canal block and catheter with the IPACK block, while the other half will receive the adductor canal block and catheter only.
Detailed Description
Total knee arthroplasty (TKA) is a surgical procedure that can be associated with significant post-operative pain. Poor pain control in the post-operative period has contributed to delays in early mobility and rehabilitation, an important part of recovery that is best started as soon as possible after surgery. Regional techniques in general have helped manage post-operative pain as well as minimize narcotic use. The application of femoral and sciatic nerve blocks has been shown to decrease opioid use; however, they were associated with adverse events such as quadriceps weakness and falls post-operatively. This led to the development of the adductor canal block (ACB) which has gained favor for providing superior analgesia over opioids alone, and for the added benefit of sparing the quadriceps muscle. Recently, adding local anesthetic to the interspace between the popliteal artery and posterior capsule of the knee (IPACK) blocks have been used to help address pain in the posterior part of the knee that is not well covered by the adductor canal block alone. While the sciatic nerve block is also an option to cover this area, it is associated with foot drop which can hinder early mobility. For patients undergoing TKAs at UCLA, our standard of practice is the ACB. The investigators hope to show with this study that adopting this novel block will help with post-operative pain control, decrease length of hospital stay, and increase distance walked during physical therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Acute Pain
Keywords
total knee arthroplasty, regional block

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adductor Canal Block + Catheter
Arm Type
Active Comparator
Arm Description
Adductor canal block: 15 mL of 0.25% ropivicaine, adductor canal catheter: 6 mL/hr of 0.2% ropivacaine
Arm Title
Adductor Canal Block + Catheter & IPACK
Arm Type
Experimental
Arm Description
Adductor canal block: 15 mL of 0.25% ropivicaine, adductor canal catheter: 6 mL/hr of 0.2% ropivacaine, IPACK block: 15 ml of 0.25% ropivacaine.
Intervention Type
Procedure
Intervention Name(s)
Adductor Canal Block + Catheter & IPACK block
Intervention Description
Adductor Canal Block + Catheter & IPACK block
Intervention Type
Procedure
Intervention Name(s)
Adductor canal block + catheter
Intervention Description
Adductor canal block + catheter
Primary Outcome Measure Information:
Title
Opioid consumption in milligram morphine equivalents
Description
Total opioid consumption will be calculated for postoperative day 0-3 ( postoperative day 0 is the day of the surgery and is the first day of the time frame and postoperative day 3 is the 4th day) and total hospital stay. Opioid amount will be converted to morphine equivalents (milligram) for comparison.
Time Frame
4 days
Secondary Outcome Measure Information:
Title
Visual analog pain scores
Description
Pain scores will be assessed postoperative day 0-3 ( postoperative day 0 is the day of the surgery and is the first day of the time frame and postoperative day 3 is the 4th day) using the visual analog score (Scale 0-10). Zero for no pain and ten being the worst pain experienced. They will be obtained and recorded every 4 to 6 hours by the nurse monitoring the subject.
Time Frame
4 days
Title
Distance ambulated during physical therapy
Description
Distance (meters) ambulated during physical therapy will be recorded for postoperative day 0-3 ( postoperative day 0 is the day of the surgery and is the first day of the time frame and postoperative day 3 is the 4th day)
Time Frame
4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients undergoing total knee replacement without contraindications to regional blocks Exclusion Criteria: Patients who have contraindications to regional blocks: infection at injection site for the nerve block, allergy to local anesthetics, history of a bleeding disorder
Facility Information:
Facility Name
UCLA Medical Center, Santa Monica
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28283810
Citation
Cullom C, Weed JT. Anesthetic and Analgesic Management for Outpatient Knee Arthroplasty. Curr Pain Headache Rep. 2017 May;21(5):23. doi: 10.1007/s11916-017-0623-y.
Results Reference
background
PubMed Identifier
29026354
Citation
Thobhani S, Scalercio L, Elliott CE, Nossaman BD, Thomas LC, Yuratich D, Bland K, Osteen K, Patterson ME. Novel Regional Techniques for Total Knee Arthroplasty Promote Reduced Hospital Length of Stay: An Analysis of 106 Patients. Ochsner J. 2017 Fall;17(3):233-238.
Results Reference
result

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IPACK and Adductor Canal Catheter Patient Outcomes for TKAs?

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