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

Not Applicable

Not yet recruiting

• Conditions: Neuromuscular Blockade; Nerve Block

• Registration Number: NCT04808947
• Lead Sponsor: Women's College Hospital

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.

Study Timeline

• Study First Submitted: 2021-03-08
• Study First Submitted QC: 2021-03-18
• Study First Posted: 2021-03-22
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-16
• Study Start: 2027-01-01
• Primary Completion: 2027-12
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quality of recovery (QoR-15)	24 hours postoperatively	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.
Postoperative pain at rest	over the first 24 hours	Area under the curve

Secondary Outcome Measures

Name	Time	Method
Mean opioid analgesic consumption	24 hours postoperatively	Postoperative cumulative oral morphine equivalent consumption during the first 24 hours
Risk of opioid-related side effects	Up until one month following nerve block	nausea, vomiting, pruritus, sedation
Block-related complications	Up until one month following nerve block	vascular puncture, hematoma formation, intravascular injection, epidural anesthesia-bilateral sensory block
Time to first analgesic request	Up to 48 hours following surgery
Pain Assessment (VAS)	at 0, 6, 12, 18 and 24 hours	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
Satisfaction with pain management	at 24 hours	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