IPACK Nerve Block for Total Knee Arthroplasty
Primary Purpose
Arthropathy of Knee, Anesthesia
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ropivacaine
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Arthropathy of Knee
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
continuous ACB with IPACK block
continuous ACB with sham subcutaneous saline injection
Arm 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
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
Outcomes
Primary Outcome Measures
Cumulative opioid consumption (morphine equivalents) in the first 24 hours
Secondary Outcome Measures
Patient satisfaction on day of discharge using the Brief Pain Inventory (BPI) or a similar validated satisfaction survey
Average pain score at rest and with physical therapy in PACU, POD#1 am, POD#1 pm
Worst pain score at rest and with physical therapy in PACU, POD#1 am, POD#1 pm
Walk distance on POD#1 am, POD#1 pm, POD#2
Time to first intravenous opioid, oral opioid in PACU and after arrival to hospital room
Time to oral-only opioids
Pain location
Hospital length of stay
Incidence of foot drop
Incidence of itching, nausea, or vomiting in PACU, POD#1am, POD#1 pm
Incidence of over-sedation based on Richmond Agitation Sedation (RASS) score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03921034
Brief Title
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
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 17, 2016 (Actual)
Primary Completion Date
January 23, 2018 (Actual)
Study Completion Date
January 23, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ochsner Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthropathy of Knee, Anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
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.
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
continuous ACB with IPACK block
Arm Type
Active Comparator
Arm 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
Arm Title
continuous ACB with sham subcutaneous saline injection
Arm Type
Sham Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Naropin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cumulative opioid consumption (morphine equivalents) in the first 24 hours
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Patient satisfaction on day of discharge using the Brief Pain Inventory (BPI) or a similar validated satisfaction survey
Time Frame
through study completion approximately 2 days
Title
Average pain score at rest and with physical therapy in PACU, POD#1 am, POD#1 pm
Time Frame
through study completion approximately 2 days
Title
Worst pain score at rest and with physical therapy in PACU, POD#1 am, POD#1 pm
Time Frame
through study completion approximately 2 days
Title
Walk distance on POD#1 am, POD#1 pm, POD#2
Time Frame
through study completion approximately 2 days
Title
Time to first intravenous opioid, oral opioid in PACU and after arrival to hospital room
Time Frame
through study completion approximately 2 days
Title
Time to oral-only opioids
Time Frame
through study completion approximately 2 days
Title
Pain location
Time Frame
through study completion approximately 2 days
Title
Hospital length of stay
Time Frame
through study completion approximately 2 days
Title
Incidence of foot drop
Time Frame
through study completion approximately 2 days
Title
Incidence of itching, nausea, or vomiting in PACU, POD#1am, POD#1 pm
Time Frame
through study completion approximately 2 days
Title
Incidence of over-sedation based on Richmond Agitation Sedation (RASS) score
Time Frame
through study completion approximately 2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Patterson, MD
Organizational Affiliation
Ochsner
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan
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IPACK Nerve Block for Total Knee Arthroplasty
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