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Chronic PainNCT05981105

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

A study testing ambIT pump with catheter in people with Chronic Pain and Opioid Use, run by Hospital for Special Surgery, New York at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Pain, Opioid Use, Adductor Canal Block
What is being tested?
ambIT pump with catheter
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
1 siteUnited States
Study dates
12 Jun 2023to 1 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Hospital for Special Surgery

    New York, New York, 10021

Other trials in United States

About this study

Official title: 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)?
Read more

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.
Read the 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.

Being tested
ambIT pump with catheter, ambIT pump with sham catheter
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ambIT pump with catheterDevice

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

  • ambIT pump with sham catheterDevice

    sham catheter with no infusion

Study groups in NCT05981105
Study groupRoleWhat they receive
Adductor Canal Catheter (ACC) - InterventionalExperimentalPatients 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.
Receives: Device: ambIT pump with catheter
Adductor Canal Block (ACB) - ControlSham comparatorPatients 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.
Receives: Device: ambIT pump with sham catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: from 24 hours to 48 hours

Secondary outcomes (28)
  1. 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.

    Measured: 72 hours to 1 week

  2. 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

    Measured: Day of surgery to post operative day (POD) 60

  3. 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).

    Measured: post operative day (POD) 1 up to POD 4

  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.

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

  5. 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"

    Measured: up to 7 days after the day of surgery

  6. 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.

    Measured: after the surgery end time, on post operative day (POD) 1, 4, and 60

  7. 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.

    Measured: On post operative day (POD) 1, 2, 3, 4

  8. 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).

    Measured: During surgery

  9. 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.

    Measured: Up to post operative day 3

  10. Distance of ambulation

    The total distance of ambulation during physical therapy while the patient is inpatient, collected from the physical therapy notes.

    Measured: post operative day (POD) 0,1,2,3,4

  11. 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

    Measured: up to post operative day 4

  12. Incidences of participants readmitted for pain control

    Whether the patient was readmitted to a hospital for additional pain control.

    Measured: 3 month after surgery

  13. Block complications

    Patients will report if they experience any block complications including, neuropraxia (saphenous), transient palsies: peroneal, tibial nerve.

    Measured: up to post operative day 4

  14. 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

    Measured: before surgery and up to post operative day 60

  15. 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

    Measured: 6 weeks

  16. 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.

    Measured: up to post operative day 60

  17. 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.

    Measured: at 3 months & 6 months

  18. 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

    Measured: at 3 months & 6 months

  19. Incidence of patient contact via text messaging/video calls

    Research staff will mark if patients contacted the pain doctor via the Diagnotes application.

    Measured: up to post operative day 4

  20. 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?)

    Measured: up to post operative day 7

  21. 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.

    Measured: before the surgery and up to post operative day 60

  22. 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.

    Measured: 3 months & 6 months

  23. Blinding Assessment

    Patient and research staff will report which group they believe the patient was randomized to.

    Measured: up to post operative day 2

  24. Incidents of participants experiencing block complications

    Data on whether patient experienced quadriceps weakness and foot drop during physical therapy. Collected from physical therapy notes.

    Measured: up to post operative day 4

  25. 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.

    Measured: up to post operative day 60

  26. 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)

    Measured: up to post operative day 7

  27. 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.

    Measured: During the surgical procedure

  28. 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.

    Measured: During the surgical procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2023
  2. Study start12 Jun 2023
  3. Primary completion7 Nov 2024
  4. Study completion1 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double-blinded randomized control trial
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05981105
Sponsor's protocol ID
2017-1858 pt 2
Status last verified
Sep 2026
First submitted
16 Jun 2023
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: No plan to share IPD with other researchers.

Publications

  • 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.

    PubMed 26508886
  • 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.

    PubMed 33426669
  • 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.

    PubMed 25695308
  • 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.

    PubMed 20889937
  • 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.

    PubMed 15866968
  • 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.

    PubMed 31663402
  • 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.

    PubMed 26200404
  • 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.

    PubMed 26618816
  • 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.

    PubMed 24401769

Questions about this trial

What is this clinical trial studying?

A study testing ambIT pump with catheter in people with Chronic Pain and Opioid Use, run by Hospital for Special Surgery, New York at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Opioid consumption at 24-48 hours (time frame: from 24 hours to 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05981105, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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