LIA vs. LIA + ACB-iPACK Block for Total Knee Arthroplasty

The Ideal Analgesic Technique for Total Knee Arthroplasty: A Randomized Comparison Between Local Infiltration Analgesia Alone or Combined With Adductor Canal and iPACK Blocks

LIA is the mainstay of postoperative analgesia in patients having knee arthroplasty. The combination of ACB-iPACK blocks has also been proposed as an effective analgesic modality for total knee arthroplasty. However, whether combining these two modalities yields any important incremental analgesic benefit remains unclear. The investigators hypothesized that the addition of ACB and iPACK blocks to LIA will yield clinically important analgesic benefits compared to LIA alone in patients having total knee arthroplasty.

Study Overview

• Status: Not yet recruiting
• Conditions: Neuromuscular Blockade; Nerve Block
• Intervention / Treatment: Procedure: Local infiltration analgesia; Procedure: Ultrasound-guided adductor canal block

Detailed Description

LIA is the mainstay of postoperative analgesia in patients having knee arthroplasty. Performed by surgeons, LIA provides effective postoperative pain relief and reduces opioid requirements. Similar analgesic benefits have also been attributed to adductor canal and iPACK blocks, which partially block sensory innervation to the knee and its posterior capsule. Performed by anesthesiologist preoperatively, these blocks have also been incorporated into the care standard in numerous centers. However, it is not clear whether adding the adductor canal and iPACK blocks yields any incremental analgesic benefits. The investigators aimed to evaluate the benefits of adding adductor canal and iPACK blocks to LIA in patients having total knee arthroplasty.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. ASA classification I-III
2. BMI < 35 kg/m2
3. Having elective unilateral total knee arthroplasty

Exclusion Criteria:

1. Bilateral knee surgery.
2. Pre-existing neurological deficit or peripheral neuropathy in the lower the lower limbs
3. Severe, poorly controlled cardiac conditions, significant arrhythmias, severe valvular heart diseases
4. Severe, poorly controlled respiratory conditions (severe COPD, severe interstitial lung disease, severe / poorly controlled asthma)
5. Contraindication to regional anesthesia (e.g. bleeding diathesis, coagulopathy, sepsis, infection at the site of potential needle puncture on the posterior chest)
6. Patient refusal
7. Chronic pain disorder
8. Chronic opioid use (≥30 mg oxycodone / day)
9. Contraindication (or allergy) to a component of multi-modal analgesia protocol
10. Allergy to amide local anesthetics used in nerve blocks
11. Contraindications to spinal anesthesia
12. Significant psychiatric disorder that would preclude objective study assessment
13. Pregnancy
14. Inability to provide informed consent

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Local infiltration analgesia; Patients in this group will receive LIA intraoperatively, as per institutional standard. The injected solution will be comprised of 100cc Ropiv 2%, + Ketorolac 30 mg + Epinephrine 25 ug.	Procedure: Local infiltration analgesia; Procedure: Local infiltration analgesia performed by surgeons.
Active Comparator: Local infiltration analgesia + ACB-iPACK block; Patients in this group will receive LIA intraoperatively, as per institutional standard. The injected solution will be comprised of 100cc Ropiv 2%, + Ketorolac 30 mg + Epinephrine 25 ug. Patients in this group will also receive preoperative nerve blocks under ultrasound guidance. These will include: Adductor canal block with 0.5% Ropivacaine w/epi 20 mL; iPack block with 0.25% Ropivacaine w/epi 10 mL	Procedure: Local infiltration analgesia; Procedure: Local infiltration analgesia performed by surgeons.; Procedure: Ultrasound-guided adductor canal block; Procedure: Ultrasound-guided adductor canal and iPACK blocks performed by anesthesiologists preoperatively.; Other Names: iPACK block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain at rest	Area under the curve	over the first 24 hours
Quality of recovery (QoR-15)	Quality of Recovery (QR15) scores at 24 hours will be the second primary outcome. QR15 is a measurement of quality of recovery after surgery and anesthesia that has been psychometrically tested and validated. Reporting of outcome measures on a scale of 0 to 10 (0=None of the time and 10=All of the time). There are a total of 40 items/questions.	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean opioid analgesic consumption	Postoperative cumulative oral morphine equivalent consumption during the first 24 hours	24 hours postoperatively
Time to first analgesic request		Up to 48 hours following surgery
Pain Assessment (VAS)	Visual Analogue Scale(VAS) - Pain:Overall pain assessed at rest and on movement A continuous scale comprised of a 100mm (10cm) horizontal line, anchored by 2 verbal descriptions No Pain to Worst Pain	at 0, 6, 12, 18 and 24 hours
Risk of opioid-related side effects	nausea, vomiting, pruritus, sedation	Up until one month following nerve block
Block-related complications	vascular puncture, hematoma formation, intravascular injection, epidural anesthesia-bilateral sensory block	Up until one month following nerve block
Satisfaction with pain management	A Patient Diary will be completed to assess overall satisfaction with analgesic technique 10 cm scale with "not satisfied at all" and "very satisfied" at either end	at 24 hours

Collaborators and Investigators

• Sponsor: Women's College Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2024
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: March 8, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: LIA vs. LIA + ACB-iPACK block

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No