Comparing Two Regional Anesthesia Interventions for Knee Arthroplasty.

NCT03944005 | Withdrawn DMC

• 1 other identifier: 113078
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 2

Brief Summary

Osteoarthritis of the knee is a common disease of the elderly and knee arthroplasty is indicated in severe cases to improve long term pain and function. Along with perioperative quality analgesia, functional recovery is paramount in the postoperative period.Loco-regional techniques provide effective analgesia and can mitigate several side effects of systemic opioids administration. Also, adequate motor sparing analgesia( to prevent weakness of the thigh muscle) following total knee arthroplasty (TKA) is therefore paramount to ensure effective rehabilitation, early recovery, readiness to discharge or timely hospital discharge. There are several motor sparing regional technique described in literature. Adductor canal block (ACB), use of intrathecal ( IT) morphine and local infiltration by the surgeons (LIA) are such examples. Previous studies have shown the combination of ACB and IT morphine to be superior than LIA in providing analgesia. Posterior knee infiltration (IPACK), involves blocking the branches of the tibial nerve which provides sensory innervation for the posterior aspect of the knee. In combination with ACB, a motor sparing analgesic intervention is possible for knee arthroplasty. Rationale for doing the study is to evaluate

1. 1.The effectiveness of IPACK block as a part of multimodal analgesic approach to knee arthroplasty surgery.
2. 2.Enhanced recovery from superior motor sparing analgesia.
3. 3.early hospital discharge We hypothesize that, following total knee arthroplasty surgery, the combination of continuous adductor canal catheter and I-PACK blocks will achieve a decrease in the time to readiness to hospital discharge as measured by the following four criteria: (1) adequate analgesia; (2) independence from intravenous opioids; (3) ability to independently stand, walk 3 m (metres), return, and sit down; and (4) independently ambulate 30 m without limitation of time. We postulate this will occur by providing superior motor-sparing analgesia compared to LIA for knee arthroplasty surgery.

Conditions

Knee Arthroplasty

Keywords

knee arthroplasty; discharge readiness; analgesia; adductor canal block; ipack; LIA

Outcome Measures

Primary Outcomes (1)

• Time to achieve a collective four-point criterion for readiness to discharge from hospital after knee arthroplasty surgery.

  1- adequate analgesia - pain score less than 4 on numerical rating scale of 11. (0 signifies no pain and 10 signifies maximum possible pain). Assessment will be performed in postoperative care unit (PACU) and every 12 hours till hospital discharge. 2 - independence from intravenous opioids. Assessment will be performed in postoperative care unit (PACU) and every 12 hours till hospital discharge. 3 - ability to independently stand, walk 3 metres (m), return and sit down (TUG test). Assessment will be performed every 12 hours till hospital discharge. 4 - independently ambulate 30m with or without mechanical support (crutch) without any time limit. Assessment will be performed every 12 hours till hospital discharge.

  3 days

Secondary Outcomes (8)

• Post-Operative pain scores

  3 days

• Total opioid consumptions in I.V. morphine equivalents

  3 days

• Functional outcomes

  3 days and at 3rd month

• Total length of hospital stay

  3 days

• Nausea and vomiting

  3 days

Study Arms (2)

Study Group

ACTIVE COMPARATOR

Spinal Anesthesia + ACB continuous catheter+ iPACK + Sham LIA

Procedure: Spinal Anesthesia + ACB continious catheter + iPACK + Sham LIA

Comparator Group

SHAM COMPARATOR

Spinal Anesthesia + LIA + Sham Blocks

Procedure: Spinal Anesthesia + LIA + Sham Blocks

Interventions

Spinal Anesthesia + ACB continious catheter + iPACK + Sham LIA PROCEDURE

ACB - On identification of adductor canal,10ml ropivacaine 0.5% with 1:400,000 epinephrine will be injected to surround the femoral artery.Following catheter placement, another 10ml of the same solution will be injected. Continuous infusion of 5ml/hr 0.2% ropivacaine will be infused till considered ready to discharge. Ipack - Posterior knee infiltration will be performed following ACB. On visualization of femoral condyle and popliteal artery, 20ml ropivacaine 0.5% with 1:400,000 epinephrine will be infiltrated in muscular space between popliteal artery and posterior femoral condyle. Spinal anesthesia will be performed following nerve blocks. All patients will receive 2-3ml of 0.75% preservative-free bupivacaine at the level of L2-3 or L3-4 intervertebral space. LIA - Patients in Group 1 will receive local infiltration 100ml of normal saline around the knee capsule of 100ml of normal saline by the surgeons as a Sham injection.

Study Group

Spinal Anesthesia + LIA + Sham Blocks PROCEDURE

ACB - On identification of adductor canal, 10ml of saline as a sham solution will be injected to surround the femoral artery. Following catheter placement, another 10ml of the same solution will be injected. Continuous infusion of 5ml/hr of saline will be infused till considered ready to discharge. Ipack - Posterior knee infiltration will be performed following ACB. On visualization of the femoral condyle and popliteal artery, 20ml of saline will be infiltrated in the muscular space between popliteal artery and posterior femoral condyle. Spinal anesthesia will be performed following the nerve blocks. All patients will receive 2-3ml of 0.75% preservative-free bupivacaine injected at the level of L2-3 or L3-4 intervertebral space. LIA - Patients will receive local infiltration by the attending surgeon intraoperatively with 300mg of ropivacaine (100ml of 0.3% ropivacaine),30 mg of ketorolac, and 10mg of morphine around the knee capsule.

Comparator Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA Physical Status I-III
• years of age
• BMI 18 - 40
• Scheduled for elective unilateral primary total knee arthroplasty under spinal anesthesia.
• Able to ambulate independently with a standard wheeled walker as maximum mobility aid.

You may not qualify if:

• Revision knee arthroplasty
• Bilateral knee arthroplasty
• Inability to provide informed consent
• Patient scheduled for a second knee arthroplasty operation at a later date.
• Neuropathic pain or sensory disorders of the surgical limb already diagnosis by a physician.
• Contraindication to regional anesthesia.
• Chronic opioid use defined as \> 60 mg of daily oral morphine equivalents.
• Patients who did not receive spinal anesthesia with intrathecal morphine or needed general anesthetics due to failed spinal anesthesia

Sponsors & Collaborators

• Western University, Canada: lead
• George Eliot Hospital NHS Trust: collaborator

Study Sites (2)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

George Elliot Hospital NHS Trust

Nuneaton, Warwickshire, CV10 7DJ, United Kingdom

Location

Related Publications (29)

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  PMID: 23788070 BACKGROUND

• The impact of arthritis in Canada: Today and Over the next 30 years. Arthritis Alliance of Canada. 2011 report.

  RESULT

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  RESULT

MeSH Terms

Conditions

Agnosia

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: May 9, 2019
• Study Start: July 1, 2020
• Primary Completion: January 1, 2024
• Study Completion: May 1, 2024
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); GB (1)