Clinical trial NCT03747146: Enhanced Recovery After Surgery (ERAS) Total Knee Replacement (TKR) With a Transitional Pain Service
Official title: Expanding the Peri-operative Surgical Home Model: ERAS TKR With a Transitional Pain Service (TeleTPS)- Continuous Adductor Canal Catheter Versus Adductor Canal Block for Total Knee Arthroplasty, a Randomized Double-blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anesthesia
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Opioid consumption during 24-48 hour period
timeFrame: Post-operative day 1-2 (24-48 hours post spinal induction)
Secondary outcomes:
measure: Opioid consumption during post-anesthesia care unit (PACU) stay
timeFrame: Day of surgery from PACU arrival until transfer to in-patient floor (up to 48 hours)
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: David Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: