IPACK Nerve Block for Total Knee Arthroplasty

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Arthropathy of Knee
• Intervention / Treatment: Drug: Ropivacaine; Drug: Saline

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: continuous ACB with IPACK block; 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	Drug: Ropivacaine; All patients will receive sedation with midazolam and/or fentanyl titrated to comfort during block procedures. Per our standard practice at Ochsner Medical Center, all patients will have either spinal or combined spinal-epidural anesthesia with mepivacaine 1.5% as the primary anesthetic during the surgery and sedation with propofol titrated to comfort. Also per our standard practice at Ochsner Medical Center, multimodal therapy will include ketamine 0.25mg/kg IV (up to 50mg) intraoperatively, dexamethasone 8mg IV intraoperatively, pregablin 150mg PO preoperatively (adjusted to 75mg for age over 70) followed by 75mg nightly (or home gabapentin dose), acetaminophen 1000mg IV followed by 100mg PO every 6 hours postoperatively, and celecoxib 400mg PO on POD #0 followed by 200mg PO daily.; Other Names: Naropin
Sham Comparator: continuous ACB with sham subcutaneous saline injection; 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	Drug: Ropivacaine; All patients will receive sedation with midazolam and/or fentanyl titrated to comfort during block procedures. Per our standard practice at Ochsner Medical Center, all patients will have either spinal or combined spinal-epidural anesthesia with mepivacaine 1.5% as the primary anesthetic during the surgery and sedation with propofol titrated to comfort. Also per our standard practice at Ochsner Medical Center, multimodal therapy will include ketamine 0.25mg/kg IV (up to 50mg) intraoperatively, dexamethasone 8mg IV intraoperatively, pregablin 150mg PO preoperatively (adjusted to 75mg for age over 70) followed by 75mg nightly (or home gabapentin dose), acetaminophen 1000mg IV followed by 100mg PO every 6 hours postoperatively, and celecoxib 400mg PO on POD #0 followed by 200mg PO daily.; Other Names: Naropin; Drug: Saline; All patients will receive sedation with midazolam and/or fentanyl titrated to comfort during block procedures. Per our standard practice at Ochsner Medical Center, all patients will have either spinal or combined spinal-epidural anesthesia with mepivacaine 1.5% as the primary anesthetic during the surgery and sedation with propofol titrated to comfort. Also per our standard practice at Ochsner Medical Center, multimodal therapy will include ketamine 0.25mg/kg IV (up to 50mg) intraoperatively, dexamethasone 8mg IV intraoperatively, pregablin 150mg PO preoperatively (adjusted to 75mg for age over 70) followed by 75mg nightly (or home gabapentin dose), acetaminophen 1000mg IV followed by 100mg PO every 6 hours postoperatively, and celecoxib 400mg PO on POD #0 followed by 200mg PO daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cumulative opioid consumption (morphine equivalents) in the first 24 hours	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Patient satisfaction on day of discharge using the Brief Pain Inventory (BPI) or a similar validated satisfaction survey	through study completion approximately 2 days
Average pain score at rest and with physical therapy in PACU, POD#1 am, POD#1 pm	through study completion approximately 2 days
Worst pain score at rest and with physical therapy in PACU, POD#1 am, POD#1 pm	through study completion approximately 2 days
Walk distance on POD#1 am, POD#1 pm, POD#2	through study completion approximately 2 days
Time to first intravenous opioid, oral opioid in PACU and after arrival to hospital room	through study completion approximately 2 days
Time to oral-only opioids	through study completion approximately 2 days
Pain location	through study completion approximately 2 days
Hospital length of stay	through study completion approximately 2 days
Incidence of foot drop	through study completion approximately 2 days
Incidence of itching, nausea, or vomiting in PACU, POD#1am, POD#1 pm	through study completion approximately 2 days
Incidence of over-sedation based on Richmond Agitation Sedation (RASS) score	through study completion approximately 2 days

Collaborators and Investigators

• Sponsor: Ochsner Health System
• Investigators: Principal Investigator: Matthew Patterson, MD, Ochsner

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2016
• Primary Completion (Actual): January 23, 2018
• Study Completion (Actual): January 23, 2018

Study Registration Dates

• First Submitted: April 10, 2019
• First Submitted That Met QC Criteria: April 15, 2019
• First Posted (Actual): April 19, 2019

Study Record Updates

• Last Update Posted (Actual): April 19, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 2016.307.C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No