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

Neuromuscular Blockade Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04808947
• Other study ID #: LIA vs. LIA + ACB-iPACK block
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2023
• Source: Women's College Hospital
• Contact: Didem Bozak
• Phone: 416-323-6008
• Email: didem.bozak[@]wchospital.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Nerve Block
• Neuromuscular Blockade

Intervention

Procedure:
• Local infiltration analgesia
Procedure: Local infiltration analgesia performed by surgeons.
• Ultrasound-guided adductor canal block
Procedure: Ultrasound-guided adductor canal and iPACK blocks performed by anesthesiologists preoperatively.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Women's College Hospital

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain at rest	Area under the curve	over the first 24 hours
Primary	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	Mean opioid analgesic consumption	Postoperative cumulative oral morphine equivalent consumption during the first 24 hours	24 hours postoperatively
Secondary	Time to first analgesic request		Up to 48 hours following surgery
Secondary	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
Secondary	Risk of opioid-related side effects	nausea, vomiting, pruritus, sedation	Up until one month following nerve block
Secondary	Block-related complications	vascular puncture, hematoma formation, intravascular injection, epidural anesthesia-bilateral sensory block	Up until one month following nerve block
Secondary	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