Clinical trial NCT05981105: Enhanced Recovery After Major Surgery and Chronic Pain for Total Knee Arthroplasty
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-blinded Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Opioid Use
Adductor Canal Block
Total Knee Arthroplasty
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blinded randomized control trial
Primary purpose: OTHER

Brief summary: The goal of this interventional clinical trial is to assess opioid consumption 24-48 hrs post anesthesia block among patients undergoing total knee arthroplasty. The main question it aims to answer is:

1. Is there a difference in opioid consumption 24-48 hours post block administration among patients that receive an adductor canal catheter (ACC) versus adductor canal block (ACB)?

Participants will be:

* Randomized to receive an adductor canal catheter (ACC) or a sham adductor canal catheter.
* Asked to use the Diagnotes application to communicate with the pain doctor while the catheter is in place.
* Follow up for up to 6 months post-operation. Researchers will compare the interventional group (ACC) to the control group (sham ACC + ACB) to see if there is difference in opioid consumption and chronic pain at 6 months post-operation.

Detailed description: The purpose of this study is to see if adding a continuous ACB catheter will extend analgesia beyond the 24-48 hour period. This interventional clinical trial will assess opioid consumption in patients undergoing total knee arthroplasty 24 to 48 hours after anesthesia block. Rebound pain is a well-known phenomenon in which patients experience severe pain immediately after the nerve block is removed. It is also known that by extending the duration of analgesia, you can reduce or prevent rebound pain. Motor sparing compartment blocks have transformed patients' ability to participate in rehabilitation earlier than ever before, even ambulating on POD 0. Thus, by extending analgesia and encouraging early ambulation, adductor canal catheters are likely to not only reduce opioid consumption but also allow for earlier discharge. The two "hot" themes in recent total knee replacement analgesia pathways are not only providing an effective Enhanced recovery after surgery (ERAD) protocol, but also combating the opioid epidemic through regional anesthesia and non-opioid multimodal pathways. This study will assist in determining which modality is superior (single shot blocks with additive versus catheter) and will introduce a novel method of following patients at home via a transitional pain service (telemedicine). This research will further investigate chronic pain 6 months after surgery.

Patients in the intervention group will have a catheter that continuously infuses numbing medication into their operative leg for 50 hours (up to POD 3). It is hypothesized that the patient will have better pain control, mobility, and less rebound pain, which is common following POD 1. By infusing the catheter with a disposable single use ambIT system (Summit Medical Products), all patients enrolled in the intervention group (ACC) will have the same amount running continuously, allowing the patient to be discharged with the catheter in place before the 50-hour infusion is completed. Prior to discharge, patients will be instructed on how to remove the catheter and will be able to download the Smartphone app "Diagnotes" at the hospital. While the catheter is in place, the Diagnotes app (a HIPPA-compliant text messaging service) will be the patient's primary means of communication with the pain doctor at home.

Patients in the control group will have a sham (fake) catheter attached to their operative leg for 50 hours. Patients will also be instructed on how to remove the catheter prior to discharge and will be able to download the Smartphone app "Diagnotes" in the hospital. While the catheter is in place, the Diagnotes app (a HIPPA-compliant text messaging service) will be the patient's primary means of communication with the pain doctor at home.

Researchers will contact both groups for follow-ups for up to 6 months.

Eligibility criteria: Inclusion Criteria:

* Patients with osteoarthritis scheduled for a primary total knee arthroplasty with a participating surgeon
* Age 18 to 75 years
* Planned use of regional anesthesia
* Ability to follow study protocol
* English speaking (secondary outcomes include questionnaires validated in English only)
* Patients of participating surgeons: Drs. Mayman, Jerabek, Westrich, Su, Della Valle, Alexiades
* Lives within one hour of the hospital
* Has a smartphone

Exclusion Criteria:

* Hepatic or renal insufficiency
* Younger than 18 years old and older than 65
* Patients undergoing general anesthesia
* Allergy or intolerance to one of the study medications
* BMI \> 40
* Diabetes
* ASA of III,IV
* Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
* PCS \> 30
* Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine equivalent of \>5mg/day for one month)
* 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 if a catheter is to be sent home with the patient
* Patients with planned stay at rehab facility

Primary outcomes:
measure: Opioid consumption at 24-48 hours
timeFrame: from 24 hours to 48 hours
Secondary outcomes:
measure: Opioid consumption at 72 hours, 96 hours, and 1 week
timeFrame: 72 hours to 1 week
measure: Numerical Pain Rating Score
timeFrame: Day of surgery to post operative day (POD) 60
measure: Physical Therapy Milestones
timeFrame: post operative day (POD) 1 up to POD 4
measure: Patient Satisfaction with Pain Control
timeFrame: post operative day (POD) 1, 2, 4 & 60
measure: Hospital Length of Stay
timeFrame: up to 7 days after the day of surgery
measure: Opioid Related Symptom Distress Scale (ORSDS)
timeFrame: after the surgery end time, on post operative day (POD) 1, 4, and 60
measure: Number of participants who experienced Buckling/Falls/Quadricep during physical therapy
timeFrame: On post operative day (POD) 1, 2, 3, 4
measure: Incidents of participants experiencing a blood loss during surgical procedure
timeFrame: During surgery
measure: Block resolution
timeFrame: Up to post operative day 3
measure: Distance of ambulation
timeFrame: post operative day (POD) 0,1,2,3,4
measure: Catheter related complications
timeFrame: up to post operative day 4
measure: Incidences of participants readmitted for pain control
timeFrame: 3 month after surgery
measure: Block complications
timeFrame: up to post operative day 4
measure: Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.)
timeFrame: before surgery and up to post operative day 60
measure: Orthopedic Outcome Flexion/Knee Society Score
timeFrame: 6 weeks
measure: SF-36 questionnaire
timeFrame: up to post operative day 60
measure: Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)
timeFrame: at 3 months & 6 months
measure: Current opioid misuse measure (COMM)
timeFrame: at 3 months & 6 months
measure: Incidence of patient contact via text messaging/video calls
timeFrame: up to post operative day 4
measure: Number of unused opioids
timeFrame: up to post operative day 7
measure: Pain catastrophizing scale (PCS)
timeFrame: before the surgery and up to post operative day 60
measure: Pain Disability Index (PDI)
timeFrame: 3 months & 6 months
measure: Blinding Assessment
timeFrame: up to post operative day 2
measure: Incidents of participants experiencing block complications
timeFrame: up to post operative day 4
measure: Non Opioid Pain medications consumption
timeFrame: up to post operative day 60
measure: Intravenous patient control analgesia (IV PCA) usage
timeFrame: up to post operative day 7
measure: Length of induction
timeFrame: During the surgical procedure
measure: Length of tourniquet use
timeFrame: During the surgical procedure
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: Stavros Memtsoudis, MD/PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital for Special Surgery, New York
name: Jashvant Poeran, MD/PhD
role: STUDY_DIRECTOR
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