IPACK Nerve Block for Total Knee Arthroplasty

NCT03921034 | Completed Phase 4

• 1 other identifier: 2016.307.C
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Arthropathy of Knee; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Cumulative opioid consumption (morphine equivalents) in the first 24 hours

  24 hours

Secondary Outcomes (11)

• 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

Study Arms (2)

continuous ACB with IPACK block

ACTIVE COMPARATOR

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

continuous ACB with sham subcutaneous saline injection

SHAM COMPARATOR

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; Drug: Saline

Interventions

Ropivacaine DRUG

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.

Also known as: Naropin

continuous ACB with IPACK block; continuous ACB with sham subcutaneous saline injection

Saline DRUG

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.

continuous ACB with sham subcutaneous saline injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ochsner Health System: lead

MeSH Terms

Interventions

Ropivacaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Matthew Patterson, MD

  Ochsner

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Only the regional anesthesiologist performing the block will know the randomization status. The study participants, outcome assessors/researchers, other anesthesia personnel, surgeons, physician assistants, and nurses will be blinded to the treatment arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 19, 2019
• Study Start: November 17, 2016
• Primary Completion: January 23, 2018
• Study Completion: January 23, 2018
• Last Updated: April 19, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share