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

Not Applicable

Recruiting

• Conditions: Anesthesia
• Interventions: Device: Adductor Canal block with sham catheter; Device: Continuous Adductor Canal Catheter (ACC)

• Registration Number: NCT03747146
• Lead Sponsor: Hospital for Special Surgery, New York

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.

Study Timeline

• Study First Submitted: 2018-11-06
• Study Start: 2018-11-16
• Study First Submitted QC: 2018-11-16
• Study First Posted: 2018-11-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-19
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 94

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adductor Canal block with sham catheter	Adductor Canal block with sham catheter	Patients will receive a combined spinal epidural, PAI, IPACK, and an adductor canal block. The patient will also receive a sham catheter.
Continuous Adductor Canal Catheter (ACC)	Continuous Adductor Canal Catheter (ACC)	Patients will receive a combined spinal epidural, PAI, IPACK, and a continuous adductor canal catheter

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Hospital for Special Surgery; 🇺🇸 New York, New York, United States