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

December 27, 2023 updated by: Hospital for Special Surgery, New York

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Total knee arthroplasties (TKA) are severely painful surgeries that require optimal pain control to ensure expeditious recovery and discharge. Nerve blocks, such as the femoral and sciatic nerves, are instrumental in effectively providing pain relief and improving patient satisfaction. However, though pain scores notably decreased with the introduction of nerve blocks, motor blockade rendered these patients immobile and may pose a fall risk early in the post-operative period. The advent of ultrasound introduces newer block techniques with adequate analgesia without the cost of motor blockade.

The adductor canal block serves as an alternative to the femoral or sciatic nerve blocks in providing anterior knee analgesia without significantly compromising quadriceps strength. However, patients' posterior knee compartment remains an issue for pain control. Sciatic and posterior tibial nerve blocks were implemented but again, results in motor blockade. A small percentage of sciatic nerve block cases also exhibit foot drop due to peroneal nerve injury. Alternatively, as a sensory block, the periarticular injection (PAI) proves to hasten ambulation and recovery after TKA. The PAI blind injection into the posterior capsule seems to aid in pain control of the posterior compartment and reduces the total number physical therapy sessions.

Injection in the interspace between the Popliteal Artery and Capsule of the posterior Knee (IPACK) provides an alternative to the PAI blind technique for analgesia in the posterior compartment. The IPACK block is not a nerve block, but rather infiltrates the area between the popliteal artery and femur. This area is rich with sensory nerve fibers from the posterior capsule of the knee, which originates from the sciatic and posterior tibial nerve. In this prospective study, we will compare pain scores between the three groups: ACB/PAI/IPACK, ACB/IPACK and PAI only. We will determine whether there is a difference between groups in NRS pain score with ambulation 24 hours post block administration.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Christopher T Garnett, BA
  • Phone Number: 212-774-7022
  • Email: GarnettC@hss.edu

Study Contact Backup

  • Name: George Birch, BA
  • Phone Number: 212-774-7377
  • Email: BirchG@hss.edu

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Hospital for Special Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Peri-Articular Injections only

Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg)

  1. Injection prior to cementation

    1. bupivacaine 0.5% with epinephrine 30cc;
    2. methylprednisolone, 40 mg/ml, 1 ml
    3. cefazolin, 500 mg in 10 ml
    4. normal saline, 22cc

  2. Superficial injection prior to closure.

    1. 20cc 0.25% bupivacaine
    2. 2 mg IV dexamethasone.
Drug: Methylprednisolone
40 mg/ml, 1 ml
Other Names:
  • Depo-Medrol, Solu-Medrol, Medrol
Drug: Cefazolin
500 mg in 10 ml
Other Names:
  • cephalosporin antibiotics
Device: 8 MHz. Chiba needle
22G/ 4 inches
Drug: Bupivacaine with epinephrine
bupivacaine 0.5% with epinephrine 30cc
Other Names:
  • Sensorcaine/Epinephrine, Sensorcaine-MPF/Epinephrine, Marcaine-Epinephrine (PF)
Drug: Bupivacaine 25cc
25 cc 0.25% bupivacaine
Other Names:
  • Exparel, Marcaine, Marcaine Spinal (PF)
Drug: Bupivacaine 20cc
20cc 0.25% bupivacaine
Other Names:
  • Exparel, Marcaine, Marcaine Spinal (PF)
Drug: Dexamethasone
2 mg IV dexamethasone.
Other Names:
  • Ozurdex, Maxidex, DexPak 6 Day
Experimental: Peri-Articular Injections, Adductor Canal Block, and IPACK

Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg)

  1. Injection prior to cementation

    1. bupivacaine 0.25% with epinephrine 30cc;
    2. methylprednisolone, 40 mg/ml, 1 ml
    3. cefazolin, 500 mg in 10 ml
    4. normal saline, 22cc

  2. Superficial injection prior to closure.

    a. 20cc 0.25% bupivacaine

  3. 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

  4. IPACK technique (supine position) a. 25 cc 0.25% bupivacaine
Drug: Methylprednisolone
40 mg/ml, 1 ml
Other Names:
  • Depo-Medrol, Solu-Medrol, Medrol
Drug: Cefazolin
500 mg in 10 ml
Other Names:
  • cephalosporin antibiotics
Device: 8 MHz. Chiba needle
22G/ 4 inches
Drug: Bupivacaine with epinephrine
bupivacaine 0.5% with epinephrine 30cc
Other Names:
  • Sensorcaine/Epinephrine, Sensorcaine-MPF/Epinephrine, Marcaine-Epinephrine (PF)
Drug: Bupivacaine 25cc
25 cc 0.25% bupivacaine
Other Names:
  • Exparel, Marcaine, Marcaine Spinal (PF)
Drug: Bupivacaine 20cc
20cc 0.25% bupivacaine
Other Names:
  • Exparel, Marcaine, Marcaine Spinal (PF)
Drug: Bupivacaine with Dexamethasone
15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone
Other Names:
  • dexamethasone to non-liposomal bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Rating Scale (NRS) Pain Scores
Time Frame: 24 hours post block administration

Numeric Rating Scale (NRS) Pain scores with ambulation 24 hours post block administration.

Min = 0, no pain Max = 10, worst imaginable pain
24 hours post block administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid Consumption
Time Frame: 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3
Opioid consumption at different intervals. Although collected at different time points, the average amount of opioid across all the time points was calculated and reported.
24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3
Numeric Rating Scale (NRS) Pain Scores at Rest and With Movement
Time Frame: 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3

Numeric Rating Scale (NRS) Pain scores at rest and with movement at different intervals Min = 0, no pain Max = 10, worst imaginable pain

Despite being collected at various times, the average pain score across all time points was calculated and reported.
24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3
Ambulation Distance During 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

The distance patients were able to walked during physical therapy ambulation. Measured in feet.

The average distance that patients walked at each time point was calculated and reported for the number of participants analyzed.
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
Level of Patient Satisfaction With Postoperative Pain Management
Time Frame: Post-Operative Day 2
Patient satisfaction with their postoperative pain management. Measured on a scale of 0 to 10, with 0 meaning extremely dissatisfied and 10 meaning extremely satisfied.
Post-Operative Day 2
Pain Outcomes
Time Frame: Post-Operative Day 1 and Post-Operative Day 2, average across the two time points reported

The Pain Outcomes (PainOUT) questionnaire was used to assess postoperative pain, psychological variables associated with pain, opioid consumption, satisfaction, and side effects. Scored on 3 scales of 0 to 10, depending on each individual question:

0 = no pain, 10 = worst pain imaginable 0 = did not interfere, 10 = completely interfered 0 = not at all, 10 = extremely

Although measured across different timepoints, the average score of all participants was calculated and reported.
Post-Operative Day 1 and Post-Operative Day 2, average across the two time points reported
Hospital Length of Stay
Time Frame: Assessed at either: 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, or 72 hours on Post-Operative Day 3

The patients' Length of Stay (LOS) at the hospital will be calculate with the time the patient entered the post-operative care unit being the "begin time" and the time patient was discharged being the "end time." The "end time" will differ for each patient depending on which day (post-operative day 1, post-operative day 2, or post-operative day 3) they were discharged.

The average length of stay for all patients (reported in minutes) will be reported.
Assessed at either: 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, or 72 hours on Post-Operative Day 3
Opioid Related Symptom Distress Scale (ORSDS)
Time Frame: Post-Operative Day 1 and Post-Operative Day 2
ORSDS scores. A lower score is a better outcome. range is 0 to 4.
Post-Operative Day 1 and Post-Operative Day 2
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr)
Time Frame: Measured at pre-operation (day of surgery) and 6 weeks post-operation

This is a patient-reported joint-specific score used to assess outcomes following total knee arthroplasty. Scores range from 0 to 100, with 0 representing total knee disability and 100 representing perfect knee health. Higher score means better outcome.

The average score for each time point is reported for each arm.
Measured at pre-operation (day of surgery) and 6 weeks post-operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital for Special Surgery, New York

Investigators

  • Principal Investigator: David H Kim, MD, Hospital for Special Surgery, New York

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2017

Primary Completion (Actual)

May 31, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

February 21, 2017

First Submitted That Met QC Criteria

March 23, 2017

First Posted (Actual)

March 29, 2017

Study Record Updates

Last Update Posted (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

December 27, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-0168

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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