Nerve Block, Neuromuscular Blockade
Conditions
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.
Interventions
PROCEDURELocal infiltration analgesia
Procedure: Local infiltration analgesia performed by surgeons.
Procedure: Ultrasound-guided adductor canal and iPACK blocks performed by anesthesiologists preoperatively.
Sponsors
Women's College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Randomized, parallel group, triple blind (patient, assessor, anesthesiologist in the operating room)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain at rest | over the first 24 hours | Area under the curve |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Risk of opioid-related side effects | Up until one month following nerve block | nausea, vomiting, pruritus, sedation |
| Mean opioid analgesic consumption | 24 hours postoperatively | Postoperative cumulative oral morphine equivalent consumption during the first 24 hours |
| 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 |
| 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 | — |
Contacts
Primary ContactDidem Bozak
Outcome results
None listed