IPACK Nerve Block for Total Knee Arthroplasty

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03921034
• Other study ID #: 2016.307.C
• Status: Completed
• Phase: Phase 4
• Start date: November 17, 2016
• Est. completion date: January 23, 2018

Study information

• Verified date: April 2019
• Source: Ochsner Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 23, 2018
• Est. primary completion date: January 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Arthropathy of Knee
• Joint Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ochsner Health System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative opioid consumption (morphine equivalents) in the first 24 hours		24 hours
Secondary	Patient satisfaction on day of discharge using the Brief Pain Inventory (BPI) or a similar validated satisfaction survey		through study completion approximately 2 days
Secondary	Average pain score at rest and with physical therapy in PACU, POD#1 am, POD#1 pm		through study completion approximately 2 days
Secondary	Worst pain score at rest and with physical therapy in PACU, POD#1 am, POD#1 pm		through study completion approximately 2 days
Secondary	Walk distance on POD#1 am, POD#1 pm, POD#2		through study completion approximately 2 days
Secondary	Time to first intravenous opioid, oral opioid in PACU and after arrival to hospital room		through study completion approximately 2 days
Secondary	Time to oral-only opioids		through study completion approximately 2 days
Secondary	Pain location		through study completion approximately 2 days
Secondary	Hospital length of stay		through study completion approximately 2 days
Secondary	Incidence of foot drop		through study completion approximately 2 days
Secondary	Incidence of itching, nausea, or vomiting in PACU, POD#1am, POD#1 pm		through study completion approximately 2 days
Secondary	Incidence of over-sedation based on Richmond Agitation Sedation (RASS) score		through study completion approximately 2 days