Studies
| Study First Submitted Date | 2021-03-08 |
| Study First Posted Date | 2021-03-22 |
| Last Update Posted Date | 2023-04-26 |
| Start Month Year | April 2024 |
| Primary Completion Month Year | December 2024 |
| Verification Month Year | April 2023 |
| Verification Date | 2023-04-30 |
| Last Update Posted Date | 2023-04-26 |
Detailed Descriptions
| Sequence: | 20614858 |
| 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. |
Conditions
| Sequence: | 51898029 | Sequence: | 51898030 |
| Name | Nerve Block | Name | Neuromuscular Blockade |
| Downcase Name | nerve block | Downcase Name | neuromuscular blockade |
Id Information
| Sequence: | 39944304 |
| Id Source | org_study_id |
| Id Value | LIA vs. LIA + ACB-iPACK block |
Design Groups
| Sequence: | 55309091 | Sequence: | 55309092 |
| Group Type | Experimental | Group Type | Active Comparator |
| Title | Local infiltration analgesia | Title | Local infiltration analgesia + ACB-iPACK block |
| Description | 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. | Description | 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 |
Interventions
| Sequence: | 52213928 | Sequence: | 52213929 |
| Intervention Type | Procedure | Intervention Type | Procedure |
| Name | Local infiltration analgesia | Name | Ultrasound-guided adductor canal block |
| Description | Procedure: Local infiltration analgesia performed by surgeons. | Description | Procedure: Ultrasound-guided adductor canal and iPACK blocks performed by anesthesiologists preoperatively. |
Design Outcomes
| Sequence: | 176449456 | Sequence: | 176449457 | Sequence: | 176449458 | Sequence: | 176449459 | Sequence: | 176449460 | Sequence: | 176449461 | Sequence: | 176449462 | Sequence: | 176449463 |
| Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | Postoperative pain at rest | Measure | Quality of recovery (QoR-15) | Measure | Mean opioid analgesic consumption | Measure | Time to first analgesic request | Measure | Pain Assessment (VAS) | Measure | Risk of opioid-related side effects | Measure | Block-related complications | Measure | Satisfaction with pain management |
| Time Frame | over the first 24 hours | Time Frame | 24 hours postoperatively | Time Frame | 24 hours postoperatively | Time Frame | Up to 48 hours following surgery | Time Frame | at 0, 6, 12, 18 and 24 hours | Time Frame | Up until one month following nerve block | Time Frame | Up until one month following nerve block | Time Frame | at 24 hours |
| Description | Area under the curve | Description | 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. | Description | Postoperative cumulative oral morphine equivalent consumption during the first 24 hours | Description | 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 | Description | nausea, vomiting, pruritus, sedation | Description | vascular puncture, hematoma formation, intravascular injection, epidural anesthesia-bilateral sensory block | Description | 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 |
Sponsors
| Sequence: | 48062664 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | Women's College Hospital |
Overall Officials
| Sequence: | 29124642 |
| Role | Principal Investigator |
| Name | Richard Brull, MD |
| Affiliation | Women's College Hospital |
Central Contacts
| Sequence: | 11949649 |
| Contact Type | primary |
| Name | Didem Bozak |
| Phone | 416-323-6008 |
| didem.bozak@wchospital.ca | |
| Role | Contact |
Design Group Interventions
| Sequence: | 67805509 | Sequence: | 67805510 | Sequence: | 67805511 |
| Design Group Id | 55309091 | Design Group Id | 55309092 | Design Group Id | 55309092 |
| Intervention Id | 52213928 | Intervention Id | 52213928 | Intervention Id | 52213929 |
Eligibilities
| Sequence: | 30603461 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | 85 Years |
| Healthy Volunteers | No |
| Criteria | Inclusion Criteria: ASA classification I-III BMI < 35 kg/m2 Having elective unilateral total knee arthroplasty Exclusion Criteria: Bilateral knee surgery. Pre-existing neurological deficit or peripheral neuropathy in the lower the lower limbs Severe, poorly controlled cardiac conditions, significant arrhythmias, severe valvular heart diseases Severe, poorly controlled respiratory conditions (severe COPD, severe interstitial lung disease, severe / poorly controlled asthma) Contraindication to regional anesthesia (e.g. bleeding diathesis, coagulopathy, sepsis, infection at the site of potential needle puncture on the posterior chest) Patient refusal Chronic pain disorder Chronic opioid use (≥30 mg oxycodone / day) Contraindication (or allergy) to a component of multi-modal analgesia protocol Allergy to amide local anesthetics used in nerve blocks Contraindications to spinal anesthesia Significant psychiatric disorder that would preclude objective study assessment Pregnancy Inability to provide informed consent |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 253917014 |
| Registered In Calendar Year | 2021 |
| Were Results Reported | False |
| Has Single Facility | False |
| Minimum Age Num | 18 |
| Maximum Age Num | 85 |
| Minimum Age Unit | Years |
| Maximum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 2 |
| Number Of Secondary Outcomes To Measure | 6 |
Designs
| Sequence: | 30350823 |
| Allocation | Randomized |
| Intervention Model | Parallel Assignment |
| Observational Model | |
| Primary Purpose | Treatment |
| Time Perspective | |
| Masking | Triple |
| Intervention Model Description | Randomized, parallel group, triple blind (patient, assessor, anesthesiologist in the operating room) |
| Subject Masked | True |
| Investigator Masked | True |
| Outcomes Assessor Masked | True |
Intervention Other Names
| Sequence: | 26541283 |
| Intervention Id | 52213929 |
| Name | iPACK block |
Responsible Parties
| Sequence: | 28724189 |
| Responsible Party Type | Sponsor |
Study References
| Sequence: | 51787709 |
| Pmid | 30234517 |
| Reference Type | background |
| 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. |