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Intraoperative Direct vs Postoperative Ultrasound Guided Adductor Canal Nerve Block After Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT03733509
Recruitment Status : Recruiting
First Posted : November 7, 2018
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile

Brief Summary:
This study compares analgesic effect between two techniques of adductor canal nerve block after total knee arthroplasty. The first group of the patients will receive intraoperative adductor canal nerve block; and the other group post operative ultrasound guided adductor canal nerve block. Investigators will measure postoperative opioid consumption, pain management and rehabilitation goals.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Total Knee Arthroplasty Nerve Block Procedure: Intraoperative Block Procedure: Ultrasound Block Procedure: Intraoperative Placebo Procedure: Ultrasound Placebo Not Applicable

Detailed Description:

Total knee arthroplasty (TKA) is a successful alternative to treat late stage knee osteoarthritis (OA). Pain management has been one of the main focuses of postoperative care. Most surgeons prefer a comprehensive multimodal approach including preoperative pharmacological treatment, intraoperative infiltration with complex drug mixes and postoperative peripheral nerve block.

The most common postoperative nerve block alternative is the proximal femoral nerve block (FNB) which has shown improvements on postoperative pain measured by reduced opioid consumption and decreased pain at rest. Its main detractors argue that the motor nerve block effect is deleterious to early ambulation and have promoted adductor canal nerve blocks (ACB). Described by Lund et al in 2011, ACB block main femoral pain sensory contributors to the knee (articular branches of obturator nerve, vastus medialis branch and saphenous nerve) but is more distal to most motor branches to the quadriceps allowing near to normal quadriceps strength.

Standard ACB block is performed under ultrasound guidance after surgery completion, still in the operating room (OR). Recent literature has shown the anatomic feasibility of intraoperative ACB via blunt suprapatellar dissection in standard medial parapatellar TKA approaches. The study seeks to determine the effectiveness of standard ultrasound guidance ACB compared with intraoperative ACB.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two arm, randomly assigned
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Total blind (patient, physicians, outcome assessors and statistician) Closed envelope by independent randomizer is given to physician assistant. The assistant prepares randomly allocated placebo or local anesthetic. Group is coded so that statistician is also blind
Primary Purpose: Treatment
Official Title: Intraoperative Direct Adductor Canal Nerve Block Versus Post Operative Ultrasound Guided Adductor Canal Nerve Block in Total Knee Arthroplasty: a Double-blind Randomized Trial
Actual Study Start Date : November 12, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intraoperative Block

Before skin closure, blunt suprapatellar dissection proximal to medial femoral condyle towards adductor canal. Nerve block at this level with 20ml of Bupivacaine 0.25%.

Postoperatively, mid-thigh ultrasound guided standard adductor canal nerve block with 20ml of saline solution (NaCl 0.9%).

Procedure: Intraoperative Block
One shot adductor canal nerve block with 20ml of bupivacaine 0.25% through surgical incision

Procedure: Ultrasound Placebo
One shot adductor canal nerve infusion with 20ml of saline solution mid-thigh

Active Comparator: Ultrasound Block

Before skin closure, blunt suprapatellar dissection proximal to medial femoral condyle towards adductor canal. Nerve block at this level with 20ml of of saline solution (NaCl 0.9%).

Postoperatively, mid-thigh ultrasound guided standard adductor canal nerve block with 20ml Bupivacaine 0.25%.

Procedure: Ultrasound Block
One shot adductor canal nerve block with 20ml of bupivacaine 0.25% mid-thigh

Procedure: Intraoperative Placebo
One shot adductor canal nerve infusion with 20ml of saline solution through surgical incision




Primary Outcome Measures :
  1. 24 hour opioid consumption [ Time Frame: First 24 hours after surgery ]
    Opioid consumption by patient controlled analgesia (PCA) and any other oral or IV analgesics


Secondary Outcome Measures :
  1. 24 patient reported pain [ Time Frame: First 24 hours after surgery ]
    Patient reported pain scale using visual analog scale (VAS) every 6 hours after surgery (0 hours, 6 hours, 12 hours, 18 hours and 24 hours)

  2. Time up and go Test [ Time Frame: 24 hours after surgery ]
    Standardised test to determine patients ability to walk 24 hours after surgery

  3. Time to Discharge [ Time Frame: 7 days ]
    Time between surgery and patient in conditions for discharge: no IV requirements, basic walking capability and VAS pain score equal or below 3

  4. Range of motion [ Time Frame: 24 hours after surgery ]
    Active and passive knee range of motion



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary total knee arthroplasty
  • Unilateral
  • American Society of Anesthesiologists (ASA) score I, II or III
  • Accepts spinal anesthesia

Exclusion Criteria:

  • General anesthesia
  • Chronic kidney disease
  • Drug or alcohol abuse
  • Chronic opioid use
  • Allergic to bupivacaine or similar

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): NCT03733509


Contacts
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Contact: Pablo Besa, MD (+569) 71399611 pablobesa@gmail.com
Contact: Fernando Altermatt, MD (+562) 2686 3270 falterma@med.puc.cl

Locations
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Chile
Pontificia Universidad Católica de Chile Recruiting
Santiago, Región Metropolitana, Chile, 8330024
Contact: Alejandro Soza, MD    56-2-23543820 ext 3820    asoza@med.puc.cl   
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
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Principal Investigator: Pablo Besa Pontificia Universidad Catolica de Chile

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Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT03733509     History of Changes
Other Study ID Numbers: 180620002
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Bupivacaine
Pharmaceutical Solutions
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents