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

NCT ID: NCT03094663

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-28
• Study Completion Date: 2018-09-01

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).

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.

Conditions

Knee Arthropathy

Keywords

IPACK; PAI

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Bupivacaine with epinephrine

Intervention Type: DRUG

bupivacaine 0.5% with epinephrine 30cc

Methylprednisolone

Intervention Type: DRUG

40 mg/ml, 1 ml

Cefazolin

Intervention Type: DRUG

500 mg in 10 ml

8 MHz. Chiba needle

Intervention Type: DEVICE

22G/ 4 inches

Bupivacaine 25cc

Intervention Type: DRUG

25 cc 0.25% bupivacaine

Bupivacaine 20cc

Intervention Type: DRUG

20cc 0.25% bupivacaine

Dexamethasone

Intervention Type: DRUG

2 mg IV dexamethasone.

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

Group Type: EXPERIMENTAL

Bupivacaine with epinephrine

Intervention Type: DRUG

bupivacaine 0.5% with epinephrine 30cc

Methylprednisolone

Intervention Type: DRUG

40 mg/ml, 1 ml

Cefazolin

Intervention Type: DRUG

500 mg in 10 ml

8 MHz. Chiba needle

Intervention Type: DEVICE

22G/ 4 inches

Bupivacaine with Dexamethasone

Intervention Type: DRUG

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

Bupivacaine 25cc

Intervention Type: DRUG

25 cc 0.25% bupivacaine

Bupivacaine 20cc

Intervention Type: DRUG

20cc 0.25% bupivacaine

Interventions

Bupivacaine with epinephrine

bupivacaine 0.5% with epinephrine 30cc

Intervention Type: DRUG

Methylprednisolone

40 mg/ml, 1 ml

Intervention Type: DRUG

Cefazolin

500 mg in 10 ml

Intervention Type: DRUG

8 MHz. Chiba needle

22G/ 4 inches

Intervention Type: DEVICE

Bupivacaine with Dexamethasone

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

Intervention Type: DRUG

Bupivacaine 25cc

25 cc 0.25% bupivacaine

Intervention Type: DRUG

Bupivacaine 20cc

20cc 0.25% bupivacaine

Intervention Type: DRUG

Dexamethasone

2 mg IV dexamethasone.

Intervention Type: DRUG

Other Intervention Names

Sensorcaine/Epinephrine, Sensorcaine-MPF/Epinephrine, Marcaine-Epinephrine (PF); Depo-Medrol, Solu-Medrol, Medrol; cephalosporin antibiotics; dexamethasone to non-liposomal bupivacaine; Exparel, Marcaine, Marcaine Spinal (PF); Exparel, Marcaine, Marcaine Spinal (PF); Ozurdex, Maxidex, DexPak 6 Day

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David H Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

Hospital For Special Surgery

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30234517 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2016-0168

Identifier Type: -

Identifier Source: org_study_id