Clinical trial NCT04808947: LIA vs. LIA + ACB-iPACK Block for Total Knee Arthroplasty
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nerve Block
Neuromuscular Blockade
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, parallel group, triple blind (patient, assessor, anesthesiologist in the operating room)
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pain at rest
timeFrame: over the first 24 hours
measure: Quality of recovery (QoR-15)
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Mean opioid analgesic consumption
timeFrame: 24 hours postoperatively
measure: Time to first analgesic request
timeFrame: Up to 48 hours following surgery
measure: Pain Assessment (VAS)
timeFrame: at 0, 6, 12, 18 and 24 hours
measure: Risk of opioid-related side effects
timeFrame: Up until one month following nerve block
measure: Block-related complications
timeFrame: Up until one month following nerve block
measure: Satisfaction with pain management
timeFrame: at 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Women's College Hospital
name: Richard Brull, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.