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IPACK and Adductor Canal Catheter Patient Outcomes for TKAs?

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ClinicalTrials.gov Identifier: NCT03774966
Recruitment Status : Completed
First Posted : December 13, 2018
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
Eva Boyd, MD, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Surgery Acute Pain Procedure: Adductor Canal Block + Catheter & IPACK block Procedure: Adductor canal block + catheter Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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?
Actual Study Start Date : February 12, 2019
Actual Primary Completion Date : May 28, 2019
Actual Study Completion Date : May 28, 2019

Arm Intervention/treatment
Active Comparator: Adductor Canal Block + Catheter
Adductor canal block: 15 mL of 0.25% ropivicaine, adductor canal catheter: 6 mL/hr of 0.2% ropivacaine
Procedure: Adductor canal block + catheter
Adductor canal block + catheter

Experimental: Adductor Canal Block + Catheter & IPACK
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.
Procedure: Adductor Canal Block + Catheter & IPACK block
Adductor Canal Block + Catheter & IPACK block




Primary Outcome Measures :
  1. Opioid consumption in milligram morphine equivalents [ Time Frame: 4 days ]
    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 :
  1. Visual analog pain scores [ Time Frame: 4 days ]
    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.

  2. Distance ambulated during physical therapy [ Time Frame: 4 days ]
    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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774966


Locations
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United States, California
UCLA Medical Center, Santa Monica
Santa Monica, California, United States, 90404
Sponsors and Collaborators
University of California, Los Angeles
Publications of Results:
Other Publications:
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Responsible Party: Eva Boyd, MD, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03774966    
Other Study ID Numbers: 18-001490
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Eva Boyd, MD, University of California, Los Angeles:
total knee arthroplasty
regional block
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms