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

• ClinicalTrials.gov Identifier: NCT04808947
• Recruitment Status: Not yet recruiting
• First Posted: March 22, 2021
• Last Update Posted: October 20, 2021
• Sponsor: Women's College Hospital
• Information provided by (Responsible Party): Women's College Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Nerve Block; Neuromuscular Blockade	Procedure: Local infiltration analgesia; Procedure: Ultrasound-guided adductor canal block	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized, parallel group, triple blind (patient, assessor, anesthesiologist in the operating room)
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Estimated Study Start Date: July 2022
• Estimated Primary Completion Date: July 2024
• Estimated Study Completion Date: July 2024

Arms and Interventions

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 Name: iPACK block

Outcome Measures

Primary Outcome Measures :

1. Postoperative pain at rest [ Time Frame: over the first 24 hours ]
   Area under the curve
2. Quality of recovery (QoR-15) [ Time Frame: 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 Outcome Measures :

1. Mean opioid analgesic consumption [ Time Frame: 24 hours postoperatively ]
   Postoperative cumulative oral morphine equivalent consumption during the first 24 hours
2. Time to first analgesic request [ Time Frame: Up to 48 hours following surgery ]
3. Pain Assessment (VAS) [ Time Frame: 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
4. Risk of opioid-related side effects [ Time Frame: Up until one month following nerve block ]
   nausea, vomiting, pruritus, sedation
5. Block-related complications [ Time Frame: Up until one month following nerve block ]
   vascular puncture, hematoma formation, intravascular injection, epidural anesthesia-bilateral sensory block
6. Satisfaction with pain management [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Didem Bozak; 416-323-6008; didem.bozak@wchospital.ca

Sponsors and Collaborators

Women's College Hospital

Investigators

• Principal Investigator: Richard Brull, MD; Women's College Hospital

More Information

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.

• Responsible Party: Women's College Hospital
• ClinicalTrials.gov Identifier: NCT04808947
• Other Study ID Numbers: LIA vs. LIA + ACB-iPACK block
• First Posted: March 22, 2021
• Last Update Posted: October 20, 2021
• Last Verified: October 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No