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

• Sponsor: Women's College Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04808947
• Collaborator: (none)
• Enrollment: 60
• Arms: 2
• Anticipated Duration (Months): 24

Study Details

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	N/A

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
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized, parallel group, triple blind (patient, assessor, anesthesiologist in the operating room)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
• Anticipated Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Jul 1, 2024
• Anticipated Study Completion Date: Jul 1, 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 Names: iPACK block

Outcome Measures

Primary Outcome Measures

1. Postoperative pain at rest [over the first 24 hours]

   Area under the curve

2. 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 Outcome Measures

1. Mean opioid analgesic consumption [24 hours postoperatively]

   Postoperative cumulative oral morphine equivalent consumption during the first 24 hours

2. Time to first analgesic request [Up to 48 hours following surgery]

3. 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

4. Risk of opioid-related side effects [Up until one month following nerve block]

   nausea, vomiting, pruritus, sedation

5. Block-related complications [Up until one month following nerve block]

   vascular puncture, hematoma formation, intravascular injection, epidural anesthesia-bilateral sensory block

6. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Women's College Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

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: Mar 22, 2021
• Last Update Posted: Oct 20, 2021
• Last Verified: Oct 1, 2021

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

Study Results

No Results Posted as of Oct 20, 2021