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The majority of patients undergoing total knee replacement(TKR) rely on opioids for postoperative analgesia. These medications have undesirable side effects and potential for abuse and addiction. The aim of this cohort study is to determine the incidence rate of patients who are able to maintain a low dose opioid regimen after TKR with the use of a multimodal approach that includes intraoperative auricular acupuncture protocol.
This is a prospective cohort study to assess the feasibility of patients to undergo TKR while adhering to a low-dose opioid regimen by using a multimodal analgesic approach that includes intraoperativeauricular acupuncture. We hypothesize that it will be feasible to maintain a low-dose opioid regimen during TKR while followingthe intraoperative auricular acupuncture protocol, and that patients will be satisfied with their pain control with a low incidence of adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postoperative Acupuncture | Experimental | Neuraxial anesthesia (spinal or combined spinal epidural (CSE) with up to 4cc mepivacaine 1.5%) and 2 blocks for postoperative pain (IPACK and adductor canal peripheral nerve blocks). Sedation will be provided. Tranexemic acid (TXA) will be dosed per surgeon request. A certified medical acupuncturist will perform ipsilateral Auricular Trauma Protocol (ATP) acupuncture at eight ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) with 30Hz electrostimulation at two of those points (Shen Men and Hypothalamus). Acupuncture needles will be left in place and stimulated for 60 min and then removed. If an epidural is placed, it may be redosed with lidocaine as needed (up to 100mg total) and will be removed prior to transfer to the recovery room. A periarticular injection (PAI) will be placed by the surgeon during the surgery (timing at the discretion of the surgeon) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Other | Ipsilateral Auricular Trauma Protocol (ATP) acupuncture at eight ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) with 30Hz electrostimulation at two of those points (Shen Men and Hypothalamus). Acupuncture needles will be left in place and stimulated for 60 min and then removed |
| Measure | Description | Time Frame |
|---|---|---|
| Low-dose Opioid Regimen Adherence | The number of patients who maintain a low-dose opioid regimen (15 pills or less of 5mg oxycodone or 112.5 OME [oral morphine equivalents]) from postoperative day (POD) 0 to POD 30 throughout their Total Knee Replacement. | postoperative day 0 to postoperative day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Opioid Consumption | Postoperative opioid consumption measured in oral morphine equivalents (OME) at various timepoints | post anesthesia care unit (PACU), postoperative day (POD) 1, POD7, POD14, POD30 |
| Numerical Rating Scale (NRS) Pain Scores at Rest and With Movement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie Cheng, MD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
Beginning 3 months and ending 5 years following article publication.
Researchers who provide a methodologically sound proposal. This will be done to achieve aims in the approved proposal. Proposals should be directed to chengs@hss.edu. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website.
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| ID | Title | Description |
|---|---|---|
| FG000 | Postoperative Acupuncture | Neuraxial anesthesia (spinal or combined spinal epidural (CSE) with up to 4cc mepivacaine 1.5%) and 2 blocks for postoperative pain (IPACK and adductor canal peripheral nerve blocks). Sedation will be provided. Tranexemic acid (TXA) will be dosed per surgeon request. A certified medical acupuncturist will perform ipsilateral Auricular Trauma Protocol (ATP) acupuncture at eight ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) with 30Hz electrostimulation at two of those points (Shen Men and Hypothalamus). Acupuncture needles will be left in place and stimulated for 60 min and then removed. If an epidural is placed, it may be redosed with lidocaine as needed (up to 100mg total) and will be removed prior to transfer to the recovery room. A periarticular injection (PAI) will be placed by the surgeon during the surgery (timing at the discretion of the surgeon) Acupuncture: Ipsilateral Auricular Trauma Protocol (ATP) acupuncture at eight ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) with 30Hz electrostimulation at two of those points (Shen Men and Hypothalamus). Acupuncture needles will be left in place and stimulated for 60 min and then removed |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Postoperative Acupuncture | Neuraxial anesthesia (spinal or combined spinal epidural (CSE) with up to 4cc mepivacaine 1.5%) and 2 blocks for postoperative pain (IPACK and adductor canal peripheral nerve blocks). Sedation will be provided. Tranexemic acid (TXA) will be dosed per surgeon request. A certified medical acupuncturist will perform ipsilateral Auricular Trauma Protocol (ATP) acupuncture at eight ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) with 30Hz electrostimulation at two of those points (Shen Men and Hypothalamus). Acupuncture needles will be left in place and stimulated for 60 min and then removed. If an epidural is placed, it may be redosed with lidocaine as needed (up to 100mg total) and will be removed prior to transfer to the recovery room. A periarticular injection (PAI) will be placed by the surgeon during the surgery (timing at the discretion of the surgeon) Acupuncture: Ipsilateral Auricular Trauma Protocol (ATP) acupuncture at eight ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) with 30Hz electrostimulation at two of those points (Shen Men and Hypothalamus). Acupuncture needles will be left in place and stimulated for 60 min and then removed |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Low-dose Opioid Regimen Adherence | The number of patients who maintain a low-dose opioid regimen (15 pills or less of 5mg oxycodone or 112.5 OME [oral morphine equivalents]) from postoperative day (POD) 0 to POD 30 throughout their Total Knee Replacement. | Posted | Number | participants | postoperative day 0 to postoperative day 30 |
|
The duration of patient enrollment (1 year)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Postoperative Acupuncture | Neuraxial anesthesia (spinal or combined spinal epidural (CSE) with up to 4cc mepivacaine 1.5%) and 2 blocks for postoperative pain (IPACK and adductor canal peripheral nerve blocks). Sedation will be provided. Tranexemic acid (TXA) will be dosed per surgeon request. A certified medical acupuncturist will perform ipsilateral Auricular Trauma Protocol (ATP) acupuncture at eight ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) with 30Hz electrostimulation at two of those points (Shen Men and Hypothalamus). Acupuncture needles will be left in place and stimulated for 60 min and then removed. If an epidural is placed, it may be redosed with lidocaine as needed (up to 100mg total) and will be removed prior to transfer to the recovery room. A periarticular injection (PAI) will be placed by the surgeon during the surgery (timing at the discretion of the surgeon) Acupuncture: Ipsilateral Auricular Trauma Protocol (ATP) acupuncture at eight ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) with 30Hz electrostimulation at two of those points (Shen Men and Hypothalamus). Acupuncture needles will be left in place and stimulated for 60 min and then removed |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stephanie Cheng | Hospital for Special Surgery | 212-606-1206 | chengs@hss.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 24, 2020 | Mar 25, 2022 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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|
| Peripheral Nerve Stimulator | Device | Ipsilateral Auricular Trauma Protocol (ATP) acupuncture at eight ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) with 30Hz electrostimulation at two of those points (Shen Men and Hypothalamus). |
|
Numerical Rating Scale (NRS) pain scores at rest and with movement. NRS pain is measured from 0 to 10, with 0 being the no pain whatsoever and 10 being the worst pain imaginable. |
| post anesthesia care unit (PACU), postoperative day (POD) 1, POD7, POD14, POD30 |
| Duration of Neuraxial Anesthesia in Hours | Duration of neuraxial anesthesia is defined as number of hours between anesthesia start time to anesthesia stop time. | postoperative day 1 |
| Deviation From Prescribed Oral Pain Regimen | Tracking the number of patients that received different oral pain main medication, including the need for rescue medications by postoperative day 30 | Postoperative day 30 |
| Number of Participants With Side Effects on POD1 and During the PACU Stay | Incidence of nausea, vomiting, pruritus (itching), and constipation. These are reported by the patient in the PACU and on postoperative day 1 | PACU, Postoperative day 1 |
| Postoperative Range of Motion | Postoperative range of motion measured at the 6 week surgeon office visit. This is being measured by either the physician or their PA and is a score that is achieved by adding extension and flexion together. It is measured in degrees. (example: flexion: 118 + extension:1 = score: 119) | 6 weeks postoperative (surgeon office visit) |
| Tourniquet Time | Duration of time the tourniquet is inflated intraoperatively. Measured in minutes | Intraoperatively |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Total Opioid Consumption | Postoperative opioid consumption measured in oral morphine equivalents (OME) at various timepoints | One patient lost to follow-up on POD1. | Posted | Mean | Standard Deviation | oral morphine equivalents (OME) | post anesthesia care unit (PACU), postoperative day (POD) 1, POD7, POD14, POD30 |
|
|
|
| Secondary | Numerical Rating Scale (NRS) Pain Scores at Rest and With Movement | Numerical Rating Scale (NRS) pain scores at rest and with movement. NRS pain is measured from 0 to 10, with 0 being the no pain whatsoever and 10 being the worst pain imaginable. | One patient lost to follow-up on POD1. Some patients were not available for administration of NRS at all time points. | Posted | Mean | Standard Deviation | score on a scale | post anesthesia care unit (PACU), postoperative day (POD) 1, POD7, POD14, POD30 |
|
|
|
| Secondary | Duration of Neuraxial Anesthesia in Hours | Duration of neuraxial anesthesia is defined as number of hours between anesthesia start time to anesthesia stop time. | Duration of neuraxial anesthesia in hours | Posted | Mean | Standard Deviation | Hours | postoperative day 1 |
|
|
|
| Secondary | Deviation From Prescribed Oral Pain Regimen | Tracking the number of patients that received different oral pain main medication, including the need for rescue medications by postoperative day 30 | Posted | Count of Participants | Participants | Postoperative day 30 |
|
|
|
| Secondary | Number of Participants With Side Effects on POD1 and During the PACU Stay | Incidence of nausea, vomiting, pruritus (itching), and constipation. These are reported by the patient in the PACU and on postoperative day 1 | Patients who answer yes to side effects in the past 24hr for POD1 | Posted | Number | participants | PACU, Postoperative day 1 |
|
|
|
| Secondary | Postoperative Range of Motion | Postoperative range of motion measured at the 6 week surgeon office visit. This is being measured by either the physician or their PA and is a score that is achieved by adding extension and flexion together. It is measured in degrees. (example: flexion: 118 + extension:1 = score: 119) | 6 weeks post-op follow up. Only 5 patients completed this secondary measure. | Posted | Mean | Standard Deviation | degrees | 6 weeks postoperative (surgeon office visit) |
|
|
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| Secondary | Tourniquet Time | Duration of time the tourniquet is inflated intraoperatively. Measured in minutes | Length of time for tourniquet inflated during the intra-operative. 5 patients out of 41 did not have tourniquets. | Posted | Mean | Standard Deviation | minutes | Intraoperatively |
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
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| D012216 |
| Rheumatic Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| POD2 |
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| POD7 |
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| POD14 |
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| POD30 |
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| POD1 |
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| POD7 |
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| POD14 |
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| POD30 |
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| Constipation |
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| Difficulty passing urine |
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| Concentrating |
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| Drowsy/staying awake |
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| Lightheaded or Dizzy |
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| Confused |
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| General fatigue/weaknesses |
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| Itchiness |
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| Dry mouth |
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| Headache |
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