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Adductor Canal Block With Periarticular Injection and IPACK (ACB/PAI/IPACK) Versus Periarticular Injection (PAI) (IPACK)

Primary Purpose

Knee Arthropathy

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Methylprednisolone
Cefazolin
8 MHz. Chiba needle
15 cc of bupivacaine 0.25% with 2 mg of preservative free Dexamethasone
25 cc 0.25% bupivacaine
20cc 0.25% bupivacaine
2 mg IV dexamethasone.
bupivacaine 0.5% with epinephrine 30cc
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Arthropathy focused on measuring IPACK, PAI

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with osteoarthritis scheduled for a primary either partial or total knee arthroplasty with a participating surgeon
  • Age 18 to 80 years
  • Planned use of regional anesthesia
  • Ability to follow study protocol
  • English speaking (secondary outcomes include questionnaires validated in English only)
  • Patients of participating surgeons

Exclusion Criteria:

  • Hepatic or renal insufficiency
  • Younger than 18 years old and older than 80
  • Patients undergoing general anesthesia
  • Allergy or intolerance to one of the study medications
  • BMI > 40
  • Diabetes
  • ASA of IV
  • Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
  • Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine equivalent of >5mg/day for one month)
  • Patients with severe valgus deformity and flexion contracture

Sites / Locations

  • Hospital For Special SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Peri-Articular Injections only

Peri-Articular Injections, Adductor Canal Block, and IPACK

Arm Description

Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) Injection prior to cementation bupivacaine 0.5% with epinephrine 30cc; methylprednisolone, 40 mg/ml, 1 ml cefazolin, 500 mg in 10 ml normal saline, 22cc Superficial injection prior to closure. 20cc 0.25% bupivacaine 2 mg IV dexamethasone.

Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) Injection prior to cementation bupivacaine 0.25% with epinephrine 30cc; methylprednisolone, 40 mg/ml, 1 ml cefazolin, 500 mg in 10 ml normal saline, 22cc Superficial injection prior to closure. a. 20cc 0.25% bupivacaine Adductor canal block technique (supine position, post IV sedation) a. Mid-thigh injection of 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone IPACK technique (supine position) a. 25 cc 0.25% bupivacaine

Outcomes

Primary Outcome Measures

NRS Pain Scores
NRS Pain scores with ambulation 24 hours post block administration

Secondary Outcome Measures

Opioid consumption
Opioid consumption at different intervals
NRS at Rest and with movement
NRS at rest and with movement at different intervals
Physical Therapy milestones
Milestones include time to ambulate and time to reach discharge criteria set by Physical Therapy
Patient Satisfaction with Pain Control using the likert scale
Satisfaction with Pain control at different intervals
PainOUT
PainOUT scores
Hospital Length of Stay
Length of Stay (LOS) calculation
Opioid Related Symptom Distress Scale (ORSDS)
ORSDS scores
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr)
KOOS Jr scores

Full Information

First Posted
February 21, 2017
Last Updated
July 2, 2018
Sponsor
Hospital for Special Surgery, New York
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1. Study Identification

Unique Protocol Identification Number
NCT03094663
Brief Title
Adductor Canal Block With Periarticular Injection and IPACK (ACB/PAI/IPACK) Versus Periarticular Injection (PAI)
Acronym
IPACK
Official Title
Analgesia After Total Knee Arthroplasty: Adductor Canal Block With Periarticular Injection and IPACK (ACB/PAI/IPACK) Versus Periarticular Injection (PAI). A Double-Blinded Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 28, 2017 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
January 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A comparison of two pain control methods - the combination of Adductor Canal Block (ACB)/Periarticular Injection (PAI)/Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (IPACK) versus the Periarticular Injection (PAI) - in patients undergoing total knee arthroplasty. Primary outcome is NRS pain scores with ambulation on postoperative day one (24 hours post-block administration).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthropathy
Keywords
IPACK, PAI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peri-Articular Injections only
Arm Type
Active Comparator
Arm Description
Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) Injection prior to cementation bupivacaine 0.5% with epinephrine 30cc; methylprednisolone, 40 mg/ml, 1 ml cefazolin, 500 mg in 10 ml normal saline, 22cc Superficial injection prior to closure. 20cc 0.25% bupivacaine 2 mg IV dexamethasone.
Arm Title
Peri-Articular Injections, Adductor Canal Block, and IPACK
Arm Type
Experimental
Arm Description
Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg) Injection prior to cementation bupivacaine 0.25% with epinephrine 30cc; methylprednisolone, 40 mg/ml, 1 ml cefazolin, 500 mg in 10 ml normal saline, 22cc Superficial injection prior to closure. a. 20cc 0.25% bupivacaine Adductor canal block technique (supine position, post IV sedation) a. Mid-thigh injection of 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone IPACK technique (supine position) a. 25 cc 0.25% bupivacaine
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
0.5% with epinephrine 30cc
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
40 mg/ml, 1 ml
Intervention Type
Drug
Intervention Name(s)
Cefazolin
Intervention Description
500 mg in 10 ml
Intervention Type
Device
Intervention Name(s)
8 MHz. Chiba needle
Intervention Description
22G/ 4 inches
Intervention Type
Drug
Intervention Name(s)
15 cc of bupivacaine 0.25% with 2 mg of preservative free Dexamethasone
Intervention Description
15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone
Intervention Type
Drug
Intervention Name(s)
25 cc 0.25% bupivacaine
Intervention Description
25 cc 0.25% bupivacaine
Intervention Type
Drug
Intervention Name(s)
20cc 0.25% bupivacaine
Intervention Description
20cc 0.25% bupivacaine
Intervention Type
Drug
Intervention Name(s)
2 mg IV dexamethasone.
Intervention Description
2 mg IV dexamethasone.
Intervention Type
Drug
Intervention Name(s)
bupivacaine 0.5% with epinephrine 30cc
Intervention Description
bupivacaine 0.5% with epinephrine 30cc
Primary Outcome Measure Information:
Title
NRS Pain Scores
Description
NRS Pain scores with ambulation 24 hours post block administration
Time Frame
24 hours post block administration
Secondary Outcome Measure Information:
Title
Opioid consumption
Description
Opioid consumption at different intervals
Time Frame
24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3
Title
NRS at Rest and with movement
Description
NRS at rest and with movement at different intervals
Time Frame
24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3
Title
Physical Therapy milestones
Description
Milestones include time to ambulate and time to reach discharge criteria set by Physical Therapy
Time Frame
It will be assessed on 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3
Title
Patient Satisfaction with Pain Control using the likert scale
Description
Satisfaction with Pain control at different intervals
Time Frame
Post-Operative Day 2
Title
PainOUT
Description
PainOUT scores
Time Frame
Post-Operative Day 1 and Post-Operative Day 2
Title
Hospital Length of Stay
Description
Length of Stay (LOS) calculation
Time Frame
It will be assessed on 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3
Title
Opioid Related Symptom Distress Scale (ORSDS)
Description
ORSDS scores
Time Frame
Post-Operative Day 1 and Post-Operative Day 2
Title
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr)
Description
KOOS Jr scores
Time Frame
baseline and 6 weeks post op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with osteoarthritis scheduled for a primary either partial or total knee arthroplasty with a participating surgeon Age 18 to 80 years Planned use of regional anesthesia Ability to follow study protocol English speaking (secondary outcomes include questionnaires validated in English only) Patients of participating surgeons Exclusion Criteria: Hepatic or renal insufficiency Younger than 18 years old and older than 80 Patients undergoing general anesthesia Allergy or intolerance to one of the study medications BMI > 40 Diabetes ASA of IV Chronic gabapentin/pregabalin use (regular use for longer than 3 months) Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine equivalent of >5mg/day for one month) Patients with severe valgus deformity and flexion contracture
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher T Garnett, BA
Phone
212-774-7022
Email
GarnettC@hss.edu
First Name & Middle Initial & Last Name or Official Title & Degree
George Birch, BA
Phone
212-774-7377
Email
BirchG@hss.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David H Kim, MD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital For Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher T Garnett, BA

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30234517
Citation
Kim DH, Beathe JC, Lin Y, YaDeau JT, Maalouf DB, Goytizolo E, Garnett C, Ranawat AS, Su EP, Mayman DJ, Memtsoudis SG. Addition of Infiltration Between the Popliteal Artery and the Capsule of the Posterior Knee and Adductor Canal Block to Periarticular Injection Enhances Postoperative Pain Control in Total Knee Arthroplasty: A Randomized Controlled Trial. Anesth Analg. 2019 Aug;129(2):526-535. doi: 10.1213/ANE.0000000000003794.
Results Reference
derived

Learn more about this trial

Adductor Canal Block With Periarticular Injection and IPACK (ACB/PAI/IPACK) Versus Periarticular Injection (PAI)

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