Clinical trial NCT03921034: IPACK Nerve Block for Total Knee Arthroplasty
Official title: Pain After Total Knee Arthroplasty: a Comparison of Combined Continuous Adductor Canal Block With Infiltration of Local Anesthetic Between the Popliteal Artery and Capsule of the Knee Block Versus Continuous Adductor Canal Block Alone on Postoperative Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthropathy of Knee
Anesthesia
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Cumulative opioid consumption (morphine equivalents) in the first 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: Patient satisfaction on day of discharge using the Brief Pain Inventory (BPI) or a similar validated satisfaction survey
timeFrame: through study completion approximately 2 days
measure: Average pain score at rest and with physical therapy in PACU, POD#1 am, POD#1 pm
timeFrame: through study completion approximately 2 days
measure: Worst pain score at rest and with physical therapy in PACU, POD#1 am, POD#1 pm
timeFrame: through study completion approximately 2 days
measure: Walk distance on POD#1 am, POD#1 pm, POD#2
timeFrame: through study completion approximately 2 days
measure: Time to first intravenous opioid, oral opioid in PACU and after arrival to hospital room
timeFrame: through study completion approximately 2 days
measure: Time to oral-only opioids
timeFrame: through study completion approximately 2 days
measure: Pain location
timeFrame: through study completion approximately 2 days
measure: Hospital length of stay
timeFrame: through study completion approximately 2 days
measure: Incidence of foot drop
timeFrame: through study completion approximately 2 days
measure: Incidence of itching, nausea, or vomiting in PACU, POD#1am, POD#1 pm
timeFrame: through study completion approximately 2 days
measure: Incidence of over-sedation based on Richmond Agitation Sedation (RASS) score
timeFrame: through study completion approximately 2 days
Other outcomes:
Locations:
Study officials:
affiliation: Ochsner
name: Matthew Patterson, MD
role: PRINCIPAL_INVESTIGATOR
References: