Enhanced Recovery After Major Surgery and Chronic Pain for Total Knee Arthroplasty
NCT ID: NCT05981105
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
64 participants
INTERVENTIONAL
2023-06-12
2025-01-01
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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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.
ambIT pump with catheter
0.2% ropivacaine will be infused through a catheter pump at a rate of 10 ml/hr, 600 ml reservoir.
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.
ambIT pump with sham catheter
sham catheter with no infusion
Interventions
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ambIT pump with catheter
0.2% ropivacaine will be infused through a catheter pump at a rate of 10 ml/hr, 600 ml reservoir.
ambIT pump with sham catheter
sham catheter with no infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Hospital for Special Surgery, New York
OTHER
Responsible Party
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Principal Investigators
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Stavros Memtsoudis, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital for Special Surgery, New York
Jashvant Poeran, MD/PhD
Role: STUDY_DIRECTOR
Hospital for Special Surgery, New York
Locations
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Hospital for Special Surgery
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Justas Lauzadis, PhD
Role: primary
Pa Thor, PhD
Role: backup
References
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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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2017-1858 pt 2
Identifier Type: -
Identifier Source: org_study_id