Anesthesia
Conditions
Brief summary
A comparison of two anesthetic techniques for total knee replacements: (1) Peri-Articular Injection (PAI), local infiltration between the popliteal artery and capsule of the knee block (IPACK) and single-shot adductor canal block (ACB) vs. (2) PAI, IPACK and continuous adductor canal block catheter (ACC).
Detailed description
Patients will be randomized to one of two groups: one group will receive a PAI, IPACK and single-shot adductor canal block; one group will receive PAI, IPACK and continuous adductor canal block catheter.
Interventions
DEVICEContinuous Adductor Canal Catheter (ACC)
At the end of the case or in the PACU, a pseudo sham catheter will be affixed mid-thigh to the skin using dermabond, steri-strips, and a chg tegaderm dressing. The catheter will be connected to the disposable pump filled with sterile saline (400 cc) and the flow rate will be set to 0. The pump will be enclosed in a carrier bag provided by the company. To ensure blinding, the carrier bag will be taped to prevent the patient from accessing it.
DEVICEAdductor Canal block with sham catheter
Adductor canal block (ACB) will be administered. At the end of the case or in the PACU, a catheter will be inserted and affixed mid-thigh to the skin using dermabond, steri-strips, and a chg tegaderm dressing. The catheter will be connected to the disposable pump filled with sterile saline (400 cc) and the flow rate will be set to 0. The pump will be enclosed in a carrier bag provided by the company. To ensure blinding, the carrier bag will be taped to prevent the patient from accessing it.
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients with osteoarthritis scheduled for a primary total knee arthroplasty with a participating surgeon * Planned use of regional anesthesia * Ability to follow study protocol * English speaking (secondary outcomes include questionnaires validated in English only) * Lives within one hour of the hospital * Has a smart phone
Exclusion criteria
* Hepatic or renal insufficiency * Younger than 18 years old or older than 65 years ol * Patients undergoing general anesthesia * Allergy or intolerance to one of the study medications * BMI \>40 * Diabetes * American Society of Anesthesiologists (ASA) status III or IV * Chronic gabapentin/pregabalin use (regular use for longer than 3 months) * Patients with chronic pain (from a referral to chronic pain service) or a pain catastrophizing scale (PCS \>30) * Patients with severe valgus deformity or flexion contracture * Patients unable to follow home catheter instructions and unwilling to go home with an infusing catheter * Patients who have no home caregivers in the event that a catheter is to be sent home with the patient * Patients with planned stay at rehab facility (to avoid medical device being tampered with at the rehab facility) * Non-English speakers (secondary outcomes include questionnaires validated in English only)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption during 24-48 hour period | Post-operative day 1-2 (24-48 hours post spinal induction) | Patients will be asked to report their opioid consumption during the 24-48 hour time period after spinal induction. This data will be converted to morphine milligram equivalents (mme). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption during post-anesthesia care unit (PACU) stay | Day of surgery from PACU arrival until transfer to in-patient floor (up to 48 hours) | Patients will be asked to report their opioid consumption during their stay in the post-anesthesia care unit. This data will be converted to morphine milligram equivalents (mme). |
Countries
United States
Contacts
CONTACTGeorge Birch, BS
PRINCIPAL_INVESTIGATORDavid Kim, MD
Hospital for Special Surgery, New York
Outcome results
None listed