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
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||88 participants|
|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|
|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|
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
- 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
- 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)
- Time up and go Test [ Time Frame: 24 hours after surgery ]Standardised test to determine patients ability to walk 24 hours after surgery
- 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
- Range of motion [ Time Frame: 24 hours after surgery ]Active and passive knee range of motion
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03733509
|Contact: Pablo Besa, MD||(+569) firstname.lastname@example.org|
|Contact: Fernando Altermatt, MD||(+562) 2686 email@example.com|
|Pontificia Universidad Católica de Chile||Recruiting|
|Santiago, Región Metropolitana, Chile, 8330024|
|Contact: Alejandro Soza, MD 56-2-23543820 ext 3820 firstname.lastname@example.org|
|Principal Investigator:||Pablo Besa||Pontificia Universidad Catolica de Chile|