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

NCT ID: NCT03733509

Last Updated: 2022-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-12

Study Completion Date

2022-10-24

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Knee Osteoarthritis Total Knee Arthroplasty Nerve Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two arm, randomly assigned
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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

Study Groups

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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%).

Group Type EXPERIMENTAL

Intraoperative Block

Intervention Type PROCEDURE

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

Ultrasound Placebo

Intervention Type PROCEDURE

One shot adductor canal nerve infusion with 20ml of saline solution mid-thigh

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%.

Group Type ACTIVE_COMPARATOR

Ultrasound Block

Intervention Type PROCEDURE

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

Intraoperative Placebo

Intervention Type PROCEDURE

One shot adductor canal nerve infusion with 20ml of saline solution through surgical incision

Interventions

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Intraoperative Block

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

Intervention Type PROCEDURE

Ultrasound Block

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

Intervention Type PROCEDURE

Intraoperative Placebo

One shot adductor canal nerve infusion with 20ml of saline solution through surgical incision

Intervention Type PROCEDURE

Ultrasound Placebo

One shot adductor canal nerve infusion with 20ml of saline solution mid-thigh

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pablo Besa

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Catolica de Chile

Locations

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Pontificia Universidad Católica de Chile

Santiago, Santiago Metropolitan, Chile

Site Status

Countries

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Chile

Other Identifiers

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180620002

Identifier Type: -

Identifier Source: org_study_id

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