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

NCT03094663 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2016-0168
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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).

Conditions

Knee Arthropathy

Keywords

IPACK; PAI

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale (NRS) Pain Scores

  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 Outcomes (8)

• Opioid Consumption

  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

  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

  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

  Post-Operative Day 2

• Pain Outcomes

  Post-Operative Day 1 and Post-Operative Day 2, average across the two time points reported

Study Arms (2)

Peri-Articular Injections only

ACTIVE COMPARATOR

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: Bupivacaine with epinephrine; Drug: Methylprednisolone; Drug: Cefazolin; Device: 8 MHz. Chiba needle; Drug: Bupivacaine 25cc; Drug: Bupivacaine 20cc; Drug: Dexamethasone

Peri-Articular Injections, Adductor Canal Block, and IPACK

EXPERIMENTAL

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: Bupivacaine with epinephrine; Drug: Methylprednisolone; Drug: Cefazolin; Device: 8 MHz. Chiba needle; Drug: Bupivacaine with Dexamethasone; Drug: Bupivacaine 25cc; Drug: Bupivacaine 20cc

Interventions

Bupivacaine with epinephrine DRUG

bupivacaine 0.5% with epinephrine 30cc

Also known as: Sensorcaine/Epinephrine, Sensorcaine-MPF/Epinephrine, Marcaine-Epinephrine (PF)

Peri-Articular Injections only; Peri-Articular Injections, Adductor Canal Block, and IPACK

Methylprednisolone DRUG

40 mg/ml, 1 ml

Also known as: Depo-Medrol, Solu-Medrol, Medrol

Peri-Articular Injections only; Peri-Articular Injections, Adductor Canal Block, and IPACK

Cefazolin DRUG

500 mg in 10 ml

Also known as: cephalosporin antibiotics

Peri-Articular Injections only; Peri-Articular Injections, Adductor Canal Block, and IPACK

8 MHz. Chiba needle DEVICE

22G/ 4 inches

Peri-Articular Injections only; Peri-Articular Injections, Adductor Canal Block, and IPACK

Bupivacaine with Dexamethasone DRUG

15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone

Also known as: dexamethasone to non-liposomal bupivacaine

Peri-Articular Injections, Adductor Canal Block, and IPACK

Bupivacaine 25cc DRUG

25 cc 0.25% bupivacaine

Also known as: Exparel, Marcaine, Marcaine Spinal (PF)

Peri-Articular Injections only; Peri-Articular Injections, Adductor Canal Block, and IPACK

Bupivacaine 20cc DRUG

20cc 0.25% bupivacaine

Also known as: Exparel, Marcaine, Marcaine Spinal (PF)

Peri-Articular Injections only; Peri-Articular Injections, Adductor Canal Block, and IPACK

Dexamethasone DRUG

2 mg IV dexamethasone.

Also known as: Ozurdex, Maxidex, DexPak 6 Day

Peri-Articular Injections only

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital For Special Surgery

New York, New York, 10021, United States

Location

Related Publications (1)

• 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.

  PMID: 30234517 DERIVED

MeSH Terms

Interventions

Bupivacaine; Epinephrine; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Cefazolin; Cephalosporins; Dexamethasone; Calcium Dobesilate

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; beta-Lactams; Lactams; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids

Results Point of Contact

• Title: Dr. David Kim
• Organization: Hospital for Special Surgery, Anesthesiology

kimd@hss.edu

2126061036

Study Officials

• David H Kim, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: March 29, 2017
• Study Start: February 28, 2017
• Primary Completion: May 31, 2018
• Study Completion: September 1, 2018
• Last Updated: December 27, 2024
• Results First Posted: January 23, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)