Enhanced Recovery After Major Surgery and Chronic Pain for Total Knee Arthroplasty

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Total Knee Arthroplasty; Opioid Use; Adductor Canal Block
• Intervention / Treatment: Device: ambIT pump with catheter; Device: ambIT pump with sham catheter

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.

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pa Thor, PhD; Phone Number: 646-797-8535; Email: thorp@hss.edu
• Study Contact Backup: Name: Stavros Memtsoudis, MD/PhD; Phone Number: 212-606-1036; Email: memtsoudiss@hss.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Hospital for Special Surgery
      • Contact: Justas Lauzadis, PhD; Phone Number: 212-774-2946; Email: lauzadisj@hss.edu
      • Contact: Pa Thor, PhD; Phone Number: 646-797-8535

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adductor Canal Catheter (ACC) - Interventional; Patients will received the an adductor canal catheter that continuously infuses numbing medication to their operative leg for 50 hours post-surgery. Patients will also communicate with their pain doctor via the Diagnotes application while the catheter is in place.	Device: ambIT pump with catheter; 0.2% ropivacaine will be infused through a catheter pump at a rate of 10 ml/hr, 600 ml reservoir.
Sham Comparator: Adductor Canal Block (ACB) - Control; Patients will received the a sham adductor canal catheter that is attached to their operative leg for 50 hours post-surgery. Patients will also communicate with their pain doctor via the Diagnotes application while the catheter is in place.	Device: ambIT pump with sham catheter; sham catheter with no infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption at 24-48 hours	The cumulative opioid consumption 24-48 hours post block administration. Measured in morphine milligram equivalents per day. Although collected over a period of time, the total amount will be summed and the average will be reported.	from 24 hours to 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption at 72 hours, 96 hours, and 1 week	The cumulative opioid consumption 72hours, 96 hours, and 1 week post block administration. Measured in morphine milligram equivalents per day. Although collected over a period of time, the total amount will be summed and the average will be reported.	72 hours to 1 week
Physical Therapy Milestones	Collected from the physical therapy notes. This outcome will assess for time to ambulation (measured in distance traveled, stairs, time of ambulating > 30 meters, and reaching discharge criteria).	post operative day (POD) 1 up to POD 4
Patient Satisfaction with Pain Control	Patients are asked to report on their satisfaction with pain control on a scale of 0 to 10, with 0 = extremely dissatisfied and 10 = extremely satisfied.	post operative day (POD) 1, 2, 4 & 60
Hospital Length of Stay	From when the patient is in the PACU to when the patient has been discharged from the hospital. PACU time = "PACU Transfer In" and Discharge time = "Discharge"	up to 7 days after the day of surgery
Opioid Related Symptom Distress Scale (ORSDS)	The Opioid-Related Symptom Distress Scale (ORSDS) is a 4-point scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 12 symptoms. The symptom-specific ORSDS is the average of the 3 symptom distress dimensions. The composite ORSDS is the average of 12 symptom-specific scores.	after the surgery end time, on post operative day (POD) 1, 4, and 60
Number of participants who experienced Buckling/Falls/Quadricep during physical therapy	Whether a participant experiences buckling, falls, or quadricep weakness during physical therapy, precluding ambulation.	On post operative day (POD) 1, 2, 3, 4
Incidents of participants experiencing a blood loss during surgical procedure	Whether the participant experienced any blood loss during their surgical procedure. Measured in binary responses (yes/no).	During surgery
Block resolution	The patient will be asked in the morning of POD 1 when they feel the block has worn off, and in the evening of POD 3 after the catheter has been removed.	Up to post operative day 3
Distance of ambulation	The total distance of ambulation during physical therapy while the patient is inpatient, collected from the physical therapy notes.	post operative day (POD) 0,1,2,3,4
Catheter related complications	Patient will be asked if they have experience any of the following with regards to the catheter: delayed weakness, unintentional dislodgment, leakage, catheter infection, dysesthesias, falls, LAST	up to post operative day 4
Incidences of participants readmitted for pain control	Whether the patient was readmitted to a hospital for additional pain control.	3 month after surgery
Block complications	Patients will report if they experience any block complications including, neuropraxia (saphenous), transient palsies: peroneal, tibial nerve.	up to post operative day 4
Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR.)	The survey asks for patients' view about their knee, such as how they feel about their knee and how well they are able to do usual activities. Choices on each question are: none, mild, moderate, severe, extreme	before surgery and up to post operative day 60
Orthopedic Outcome Flexion/Knee Society Score	Patient will be asked about their range of motion (flexion ROM and Extension ROM). Data collected from surgeon's note	6 weeks
SF-36 questionnaire	The SF-36 measures includes the following: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Measured on a scale of 1 to 3, with 1 = "yes limited a lot", 2 = "yes limited a little", 3 = "no not limited at all". The total score for each participant is calculated and then all the scores are average across all participants.	up to post operative day 60
Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)	The Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale (LANSS) comprises of a 7-item pain scale, including the sensory descriptors and items for sensory examination. Out of the seven items in the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale (LANSS), five are symptom related and two are examination items. If patient reports surgery-related pain greater than 3 on the NRS at the 3 months and 6 months postoperative visit, patient will complete this questionnaire.	at 3 months & 6 months
Current opioid misuse measure (COMM)	The Current Opioid Misuse Measure (COMM) is a commonly used self-report instrument to identify and monitor aberrant opioid-related behavior in chronic pain patients on opioid therapy. At the 3 months and 6 months postoperative visit, if patients are still being prescribed opioids, patient will be asked to fill out the questionnaire Choices on the questionnaire are: never, seldom, sometimes, often, very often	at 3 months & 6 months
Incidence of patient contact via text messaging/video calls	Research staff will mark if patients contacted the pain doctor via the Diagnotes application.	up to post operative day 4
Number of unused opioids	Patients will be asked at 1 week post-operation, about their pain medication usage (how many pills of your opioid medication do you have left?)	up to post operative day 7
Pain catastrophizing scale (PCS)	The Pain Catastrophizing Scale (PCS) assesses the extent of catastrophic thinking due to low back pain according to 3 components: rumination, magnification, and helplessness. It is a 13-item scale, with a total range of 0 to 52. Higher scores are associated with higher amounts of pain catastrophizing.	before the surgery and up to post operative day 60
Pain Disability Index (PDI)	The Pain Disability Index (PDI) is a widely-used instrument to measure pain-related disability. Scoring: Scores are assigned based on an 11-point scale ranging from 0 (no disability) to 10 (total disability). Scores range from 0 to 70. The higher the index the greater the person's disability due to pain.	3 months & 6 months
Blinding Assessment	Patient and research staff will report which group they believe the patient was randomized to.	up to post operative day 2
Incidents of participants experiencing block complications	Data on whether patient experienced quadriceps weakness and foot drop during physical therapy. Collected from physical therapy notes.	up to post operative day 4
Non Opioid Pain medications consumption	Research staff will document any non-opioid pain medications (lyrica, robaxin, tyelnol, etc) taken by each participant. Medications may be given at the discretion of the APS service.	up to post operative day 60
Intravenous patient control analgesia (IV PCA) usage	Research staff will document if patient received IV PCA during their stay at the hospital. Measured in morphine equivalent. Discharge times can vary from participant to participant (from POD 0 up until POD 2)	up to post operative day 7
Length of induction	The time it takes for the patient to be induced. Measured from induction start to induction end. Times for each participants will be calculated (in minutes) and then average across all participants.	During the surgical procedure
Length of tourniquet use	The total time to use a tourniquet. Measured from tourniquet inflated time tourniquet deflated time. Times for each participants will be calculated (in minutes) and then average across all participants.	During the surgical procedure
Numerical Pain Rating Score	Patients are asked to give a number between 0 and 10 that best fits their pain intensity. The scale is 0 = 'no pain at all' whereas 10 = 'the worst pain ever possible'. Measured at multiple time points: DOS, post-operative day (POD) 1, POD 2, POD 3, POD 4, POD 7, & POD 60	Day of surgery to post operative day (POD) 60

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Investigators: Principal Investigator: Stavros Memtsoudis, MD/PhD, Hospital for Special Surgery, New York; Study Director: Jashvant Poeran, MD/PhD, Hospital for Special Surgery, New York

Publications and helpful links

General Publications

• Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119.
• Katz J, Weinrib A, Fashler SR, Katznelzon R, Shah BR, Ladak SS, Jiang J, Li Q, McMillan K, Santa Mina D, Wentlandt K, McRae K, Tamir D, Lyn S, de Perrot M, Rao V, Grant D, Roche-Nagle G, Cleary SP, Hofer SO, Gilbert R, Wijeysundera D, Ritvo P, Janmohamed T, O'Leary G, Clarke H. The Toronto General Hospital Transitional Pain Service: development and implementation of a multidisciplinary program to prevent chronic postsurgical pain. J Pain Res. 2015 Oct 12;8:695-702. doi: 10.2147/JPR.S91924. eCollection 2015.
• Chen YK, Boden KA, Schreiber KL. The role of regional anaesthesia and multimodal analgesia in the prevention of chronic postoperative pain: a narrative review. Anaesthesia. 2021 Jan;76 Suppl 1(Suppl 1):8-17. doi: 10.1111/anae.15256.
• Benthien JP, Huebner D. Efficacy of continuous catheter analgesia of the sciatic nerve after total knee arthroplasty. Swiss Med Wkly. 2015 Feb 19;145:w14119. doi: 10.4414/smw.2015.14119. eCollection 2015.
• Ilfeld BM, Duke KB, Donohue MC. The association between lower extremity continuous peripheral nerve blocks and patient falls after knee and hip arthroplasty. Anesth Analg. 2010 Dec;111(6):1552-4. doi: 10.1213/ANE.0b013e3181fb9507. Epub 2010 Oct 1.
• Mizner RL, Petterson SC, Stevens JE, Vandenborne K, Snyder-Mackler L. Early quadriceps strength loss after total knee arthroplasty. The contributions of muscle atrophy and failure of voluntary muscle activation. J Bone Joint Surg Am. 2005 May;87(5):1047-53. doi: 10.2106/JBJS.D.01992.
• Wainwright TW, Gill M, McDonald DA, Middleton RG, Reed M, Sahota O, Yates P, Ljungqvist O. Consensus statement for perioperative care in total hip replacement and total knee replacement surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Acta Orthop. 2020 Feb;91(1):3-19. doi: 10.1080/17453674.2019.1683790. Epub 2019 Oct 30.
• Kovalak E, Dogan AT, Uzumcugil O, Obut A, Yildiz AS, Kanay E, Tuzuner T, Ozyuvaci E. A comparison of continuous femoral nerve block and periarticular local infiltration analgesia in the management of early period pain developing after total knee arthroplasty. Acta Orthop Traumatol Turc. 2015;49(3):260-6. doi: 10.3944/AOTT.2015.14.0263.
• Horn BJ, Cien A, Reeves NP, Pathak P, Taunt CJ Jr. Femoral Nerve Block vs Periarticular Bupivacaine Liposome Injection After Primary Total Knee Arthroplasty: Effect on Patient Outcomes. J Am Osteopath Assoc. 2015 Dec;115(12):714-9. doi: 10.7556/jaoa.2015.146.

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: June 16, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Equipment and Supplies; Catheters
• Other Study ID Numbers: 2017-1858 pt 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes