IPACK Nerve Block for Total Knee Arthroplasty

Ochsner Health System

Status and phase: Completed; Phase 4

Conditions: Arthropathy of Knee; Anesthesia

Treatments: Drug: Saline; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03921034

2016.307.C

Details and patient eligibility

About

Double-blind, randomized controlled clinical trial to test the efficacy of IPACK on postoperative opioid consumption, patient satisfaction, pain scores, mobility, and several other secondary outcomes in adults undergoing primary unilateral TKA.

Enrolled patients will be randomized to either continuous ACB with IPACK or to continuous ACB with sham subcutaneous saline injection. Outcomes assessors and patients will be blinded to the intervention.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Unilateral, primary tricompartment total knee arthroplasty
• Age 18 years or older
• ASA I-III
• Eligible for spinal or combined spinal epidural anesthetic
• Able to speak, read, and understand English
• Willing to participate in the trial

Exclusion criteria

• Contraindication to regional anesthesia or peripheral nerve blocks
• Allergy to local anesthetics
• Allergy to NSAIDs
• Chronic renal insufficiency with Cr > 1.4 or GFR < 60
• Have chronic pain that is not related to their knee joint
• Have been using opioids on a chronic basis (daily or almost daily opioid use for 3 months or longer)
• Have a pre-existing peripheral neuropathy involving the operative site
• Body mass index greater than or equal to 40

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups

continuous ACB with IPACK block

Active Comparator group

Description:

ACB bolused with 20 ml of ropivacaine 0.25% with 1:300,000 epinephrine followed by an 8 ml/hr continuous infusion of ropivacaine 0.2% and IPACK block with 20 ml of ropivacaine 0.25% with 1:300,000 epinephrine

Treatment:

Drug: Ropivacaine

continuous ACB with sham subcutaneous saline injection

Sham Comparator group

Description:

ACB bolused with 20 ml of ropivacaine 0.25% with 1:300,000 epinephrine followed by an 8 ml/hr continuous infusion of ropivacaine 0.2% and a sham IPACK block with subcutaneous saline injection along the medial thigh

Treatment:

Drug: Saline

Drug: Ropivacaine