Comparing Two Regional Anesthesia Interventions for Knee Arthroplasty.

NCT03944005 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-04-25

No results posted yet for this study

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. The effectiveness of IPACK block as a part of multimodal analgesic approach to knee arthroplasty surgery.
2. Enhanced recovery from superior motor sparing analgesia.
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

Interventions

PROCEDURE

Spinal Anesthesia + ACB continious catheter + iPACK + Sham LIA

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.

PROCEDURE

Spinal Anesthesia + LIA + Sham Blocks

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.

Sponsors & Collaborators

  • George Eliot Hospital NHS Trust

    collaborator OTHER
  • Western University, Canada

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-31
Primary Completion
2024-01-31
Completion
2024-05-31

Countries

  • Canada
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03944005 on ClinicalTrials.gov