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

NCT05981105 | Recruiting DMC FDA Device

• 1 other identifier: 2017-1858 pt 2
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Opioid Use; Adductor Canal Block; Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (28)

• Opioid consumption at 72 hours, 96 hours, and 1 week

  72 hours to 1 week

• Numerical Pain Rating Score

  Day of surgery to post operative day (POD) 60

• Physical Therapy Milestones

  post operative day (POD) 1 up to POD 4

• Patient Satisfaction with Pain Control

  post operative day (POD) 1, 2, 4 & 60

• Hospital Length of Stay

  up to 7 days after the day of surgery

Study Arms (2)

Adductor Canal Catheter (ACC) - Interventional

EXPERIMENTAL

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

Adductor Canal Block (ACB) - Control

SHAM COMPARATOR

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

Interventions

ambIT pump with catheter DEVICE

0.2% ropivacaine will be infused through a catheter pump at a rate of 10 ml/hr, 600 ml reservoir.

Adductor Canal Catheter (ACC) - Interventional

ambIT pump with sham catheter DEVICE

sham catheter with no infusion

Adductor Canal Block (ACB) - Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

RECRUITING

Related Publications (9)

• 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.

  PMID: 26508886 RESULT

• 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.

  PMID: 33426669 RESULT

• 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.

  PMID: 25695308 RESULT

• 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.

  PMID: 20889937 RESULT

• 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.

  PMID: 15866968 RESULT

• 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.

  PMID: 31663402 RESULT

• 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.

  PMID: 26200404 RESULT

• 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.

  PMID: 26618816 RESULT

• 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.

  PMID: 24401769 RESULT

MeSH Terms

Conditions

Chronic Pain

Interventions

Catheters

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Stavros Memtsoudis, MD/PhD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

• Jashvant Poeran, MD/PhD

  Hospital for Special Surgery, New York

  STUDY DIRECTOR

Central Study Contacts

Pa Thor, PhD

CONTACT

646-797-8535; thorp@hss.edu

Stavros Memtsoudis, MD/PhD

CONTACT

212-606-1036; memtsoudiss@hss.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomized to the intervention group (adductor canal catheter, ACC) or control group (sham adductor canal catheterm, ACB). The research staff and participants will be blinded as to which group the participant is in. The primary investigator and co-investigators will not be blinded. The research staff will provide PI and Co-I with an envelope that informs them which group the participant is randomized to so the proper research activities are carried out.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blinded randomized control trial

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: August 8, 2023
• Study Start: June 12, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)