Enhanced Recovery After Surgery (ERAS) Total Knee Replacement (TKR) With a Transitional Pain Service

ConditionAnesthesia

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorHospital for Special Surgery, New York

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Continuous Adductor Canal Catheter (ACC)
Device
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.
Adductor Canal block with sham catheter
Device
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.

Treatment groups

94 Participants

are divided into 2 treatment groups

Group A: Continuous Adductor Canal Catheter (ACC)Active comparator 1 intervention

Group B: Adductor Canal block with sham catheterSham comparator 1 intervention

Trial outcomes

Primary outcomes

Opioid consumption during 24-48 hour period

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).

Time frame

Post-operative day 1-2 (24-48 hours post spinal induction)

Secondary outcomes

Opioid consumption during post-anesthesia care unit (PACU) stay

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).

Time frame

Day of surgery from PACU arrival until transfer to in-patient floor (up to 48 hours)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital for Special Surgery, New York

Lead sponsor

Source ClinicalTrials.gov

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