Acupuncture, Knee Osteoarthritis, Pain, Postoperative
Conditions
Keywords
Acupuncture, Total Knee Replacement
Brief summary
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.
Detailed description
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.
Interventions
OTHERAcupuncture
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
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).
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* ASA of 1 or 2 * Age 18-70 * Undergoing primary total knee replacement * Desire to attempt a low opioid or opioid free pathway
Exclusion criteria
* NonEnglish speaking * Patients with the inability to understand or follow study protocol * Opioid use in the last 6 weeks or chronic pain patient * Cannot receive neuraxial anesthesia and/or peripheral nerve block * Patients with contraindications to intraop protocol (e.g., patient cannot take acetaminophen or ketorolac due to liver or kidney disease) * Patients with implanted cardiac device such as a pacemaker or AICD * Active ear infection * Nonnative ear, previous scarring or surgical manipulation of ear * Patients with gauges or other deforming ear piercing (small nondeforming ear piercings are ok) present in ears * Allergy to nickel
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Low-dose Opioid Regimen Adherence | postoperative day 0 to postoperative day 30 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Scale (NRS) Pain Scores at Rest and With Movement | post anesthesia care unit (PACU), postoperative day (POD) 1, POD7, POD14, POD30 | 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. |
| Duration of Neuraxial Anesthesia in Hours | postoperative day 1 | Duration of neuraxial anesthesia is defined as number of hours between anesthesia start time to anesthesia stop time. |
| Deviation From Prescribed Oral Pain Regimen | Postoperative day 30 | Tracking the number of patients that received different oral pain main medication, including the need for rescue medications by postoperative day 30 |
| Total Opioid Consumption | post anesthesia care unit (PACU), postoperative day (POD) 1, POD7, POD14, POD30 | Postoperative opioid consumption measured in oral morphine equivalents (OME) at various timepoints |
| Postoperative Range of Motion | 6 weeks postoperative (surgeon office visit) | 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) |
| Tourniquet Time | Intraoperatively | Duration of time the tourniquet is inflated intraoperatively. Measured in minutes |
| Number of Participants With Side Effects on POD1 and During the PACU Stay | PACU, Postoperative day 1 | Incidence of nausea, vomiting, pruritus (itching), and constipation. These are reported by the patient in the PACU and on postoperative day 1 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 41 |
| Total | 41 |
Baseline characteristics
| Characteristic | Postoperative Acupuncture |
|---|---|
| Age, Continuous | 68.9 years STANDARD_DEVIATION 7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Region of Enrollment United States | 41 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 41 |
| other Total, other adverse events | 0 / 41 |
| serious Total, serious adverse events | 0 / 41 |
Outcome results
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.
Time frame: postoperative day 0 to postoperative day 30
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Postoperative Acupuncture | Low-dose Opioid Regimen Adherence | 26 participants |
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
Time frame: Postoperative day 30
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Postoperative Acupuncture | Deviation From Prescribed Oral Pain Regimen | Lost to Follow up | 1 Participants |
| Postoperative Acupuncture | Deviation From Prescribed Oral Pain Regimen | Protocol Deviations | 0 Participants |
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.
Time frame: postoperative day 1
Population: Duration of neuraxial anesthesia in hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Postoperative Acupuncture | Duration of Neuraxial Anesthesia in Hours | 2.6 Hours | Standard Deviation 0.3 |
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
Time frame: PACU, Postoperative day 1
Population: Patients who answer yes to side effects in the past 24hr for POD1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Postoperative Acupuncture | Number of Participants With Side Effects on POD1 and During the PACU Stay | Nausea | 11 participants |
| Postoperative Acupuncture | Number of Participants With Side Effects on POD1 and During the PACU Stay | Vomiting | 4 participants |
| Postoperative Acupuncture | Number of Participants With Side Effects on POD1 and During the PACU Stay | Constipation | 3 participants |
| Postoperative Acupuncture | Number of Participants With Side Effects on POD1 and During the PACU Stay | Difficulty passing urine | 2 participants |
| Postoperative Acupuncture | Number of Participants With Side Effects on POD1 and During the PACU Stay | Concentrating | 2 participants |
| Postoperative Acupuncture | Number of Participants With Side Effects on POD1 and During the PACU Stay | Drowsy/staying awake | 8 participants |
| Postoperative Acupuncture | Number of Participants With Side Effects on POD1 and During the PACU Stay | Lightheaded or Dizzy | 8 participants |
| Postoperative Acupuncture | Number of Participants With Side Effects on POD1 and During the PACU Stay | Confused | 2 participants |
| Postoperative Acupuncture | Number of Participants With Side Effects on POD1 and During the PACU Stay | General fatigue/weaknesses | 7 participants |
| Postoperative Acupuncture | Number of Participants With Side Effects on POD1 and During the PACU Stay | Itchiness | 4 participants |
| Postoperative Acupuncture | Number of Participants With Side Effects on POD1 and During the PACU Stay | Dry mouth | 15 participants |
| Postoperative Acupuncture | Number of Participants With Side Effects on POD1 and During the PACU Stay | Headache | 7 participants |
| Side Effects PACU | Number of Participants With Side Effects on POD1 and During the PACU Stay | Dry mouth | 16 participants |
| Side Effects PACU | Number of Participants With Side Effects on POD1 and During the PACU Stay | Nausea | 7 participants |
| Side Effects PACU | Number of Participants With Side Effects on POD1 and During the PACU Stay | Lightheaded or Dizzy | 9 participants |
| Side Effects PACU | Number of Participants With Side Effects on POD1 and During the PACU Stay | Vomiting | 0 participants |
| Side Effects PACU | Number of Participants With Side Effects on POD1 and During the PACU Stay | Itchiness | 0 participants |
| Side Effects PACU | Number of Participants With Side Effects on POD1 and During the PACU Stay | Constipation | 0 participants |
| Side Effects PACU | Number of Participants With Side Effects on POD1 and During the PACU Stay | Confused | 0 participants |
| Side Effects PACU | Number of Participants With Side Effects on POD1 and During the PACU Stay | Difficulty passing urine | 3 participants |
| Side Effects PACU | Number of Participants With Side Effects on POD1 and During the PACU Stay | Headache | 0 participants |
| Side Effects PACU | Number of Participants With Side Effects on POD1 and During the PACU Stay | Concentrating | 1 participants |
| Side Effects PACU | Number of Participants With Side Effects on POD1 and During the PACU Stay | General fatigue/weaknesses | 6 participants |
| Side Effects PACU | Number of Participants With Side Effects on POD1 and During the PACU Stay | Drowsy/staying awake | 9 participants |
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.
Time frame: post anesthesia care unit (PACU), postoperative day (POD) 1, POD7, POD14, POD30
Population: One patient lost to follow-up on POD1. Some patients were not available for administration of NRS at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Postoperative Acupuncture | Numerical Rating Scale (NRS) Pain Scores at Rest and With Movement | Pre-Op | 5.1 score on a scale | Standard Deviation 2.2 |
| Postoperative Acupuncture | Numerical Rating Scale (NRS) Pain Scores at Rest and With Movement | POD0 | 4.2 score on a scale | Standard Deviation 2.7 |
| Postoperative Acupuncture | Numerical Rating Scale (NRS) Pain Scores at Rest and With Movement | POD1 | 3.7 score on a scale | Standard Deviation 2 |
| Postoperative Acupuncture | Numerical Rating Scale (NRS) Pain Scores at Rest and With Movement | POD7 | 3.7 score on a scale | Standard Deviation 2.2 |
| Postoperative Acupuncture | Numerical Rating Scale (NRS) Pain Scores at Rest and With Movement | POD14 | 3 score on a scale | Standard Deviation 1.8 |
| Postoperative Acupuncture | Numerical Rating Scale (NRS) Pain Scores at Rest and With Movement | POD30 | 2.4 score on a scale | Standard Deviation 1.9 |
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)
Time frame: 6 weeks postoperative (surgeon office visit)
Population: 6 weeks post-op follow up. Only 5 patients completed this secondary measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Postoperative Acupuncture | Postoperative Range of Motion | 113.2 degrees | Standard Deviation 20.5 |
Secondary
Total Opioid Consumption
Postoperative opioid consumption measured in oral morphine equivalents (OME) at various timepoints
Time frame: post anesthesia care unit (PACU), postoperative day (POD) 1, POD7, POD14, POD30
Population: One patient lost to follow-up on POD1.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Postoperative Acupuncture | Total Opioid Consumption | PACU | 14.9 oral morphine equivalents (OME) | Standard Deviation 12.4 |
| Postoperative Acupuncture | Total Opioid Consumption | POD1 | 11.9 oral morphine equivalents (OME) | Standard Deviation 20 |
| Postoperative Acupuncture | Total Opioid Consumption | POD2 | 7.3 oral morphine equivalents (OME) | Standard Deviation 15.5 |
| Postoperative Acupuncture | Total Opioid Consumption | POD7 | 13.5 oral morphine equivalents (OME) | Standard Deviation 55.7 |
| Postoperative Acupuncture | Total Opioid Consumption | POD14 | 108.3 oral morphine equivalents (OME) | Standard Deviation 190.4 |
| Postoperative Acupuncture | Total Opioid Consumption | POD30 | 0 oral morphine equivalents (OME) | Standard Deviation 0 |
Secondary
Tourniquet Time
Duration of time the tourniquet is inflated intraoperatively. Measured in minutes
Time frame: Intraoperatively
Population: Length of time for tourniquet inflated during the intra-operative. 5 patients out of 41 did not have tourniquets.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Postoperative Acupuncture | Tourniquet Time | 60.5 minutes | Standard Deviation 11.7 |