Trial Outcomes & Findings for Acupuncture for Low-Dose Opioid for TKA Replacement (NCT NCT04084288)
NCT ID: NCT04084288
Last Updated: 2024-12-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
postoperative day 0 to postoperative day 30
Results posted on
2024-12-27
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acupuncture for Low-Dose Opioid for TKA Replacement
Baseline characteristics by cohort
| Measure |
Postoperative Acupuncture
n=41 Participants
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
|
|---|---|
|
Age, Continuous
|
68.9 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: postoperative day 0 to postoperative day 30The 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.
Outcome measures
| Measure |
Postoperative Acupuncture
n=41 Participants
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
|
Side Effects PACU
Incidence of nausea, vomiting, pruritus, constipation reported in the PACU by patient
|
|---|---|---|
|
Low-dose Opioid Regimen Adherence
|
26 participants
|
—
|
SECONDARY outcome
Timeframe: post anesthesia care unit (PACU), postoperative day (POD) 1, POD7, POD14, POD30Population: One patient lost to follow-up on POD1.
Postoperative opioid consumption measured in oral morphine equivalents (OME) at various timepoints
Outcome measures
| Measure |
Postoperative Acupuncture
n=41 Participants
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
|
Side Effects PACU
Incidence of nausea, vomiting, pruritus, constipation reported in the PACU by patient
|
|---|---|---|
|
Total Opioid Consumption
POD14
|
108.3 oral morphine equivalents (OME)
Standard Deviation 190.4
|
—
|
|
Total Opioid Consumption
PACU
|
14.9 oral morphine equivalents (OME)
Standard Deviation 12.4
|
—
|
|
Total Opioid Consumption
POD1
|
11.9 oral morphine equivalents (OME)
Standard Deviation 20
|
—
|
|
Total Opioid Consumption
POD2
|
7.3 oral morphine equivalents (OME)
Standard Deviation 15.5
|
—
|
|
Total Opioid Consumption
POD7
|
13.5 oral morphine equivalents (OME)
Standard Deviation 55.7
|
—
|
|
Total Opioid Consumption
POD30
|
0 oral morphine equivalents (OME)
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: post anesthesia care unit (PACU), postoperative day (POD) 1, POD7, POD14, POD30Population: One patient lost to follow-up on POD1. Some patients were not available for administration of NRS at all time points.
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.
Outcome measures
| Measure |
Postoperative Acupuncture
n=41 Participants
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
|
Side Effects PACU
Incidence of nausea, vomiting, pruritus, constipation reported in the PACU by patient
|
|---|---|---|
|
Numerical Rating Scale (NRS) Pain Scores at Rest and With Movement
Pre-Op
|
5.1 score on a scale
Standard Deviation 2.2
|
—
|
|
Numerical Rating Scale (NRS) Pain Scores at Rest and With Movement
POD0
|
4.2 score on a scale
Standard Deviation 2.7
|
—
|
|
Numerical Rating Scale (NRS) Pain Scores at Rest and With Movement
POD1
|
3.7 score on a scale
Standard Deviation 2
|
—
|
|
Numerical Rating Scale (NRS) Pain Scores at Rest and With Movement
POD7
|
3.7 score on a scale
Standard Deviation 2.2
|
—
|
|
Numerical Rating Scale (NRS) Pain Scores at Rest and With Movement
POD14
|
3 score on a scale
Standard Deviation 1.8
|
—
|
|
Numerical Rating Scale (NRS) Pain Scores at Rest and With Movement
POD30
|
2.4 score on a scale
Standard Deviation 1.9
|
—
|
SECONDARY outcome
Timeframe: postoperative day 1Population: Duration of neuraxial anesthesia in hours
Duration of neuraxial anesthesia is defined as number of hours between anesthesia start time to anesthesia stop time.
Outcome measures
| Measure |
Postoperative Acupuncture
n=41 Participants
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
|
Side Effects PACU
Incidence of nausea, vomiting, pruritus, constipation reported in the PACU by patient
|
|---|---|---|
|
Duration of Neuraxial Anesthesia in Hours
|
2.6 Hours
Standard Deviation 0.3
|
—
|
SECONDARY outcome
Timeframe: Postoperative day 30Tracking the number of patients that received different oral pain main medication, including the need for rescue medications by postoperative day 30
Outcome measures
| Measure |
Postoperative Acupuncture
n=41 Participants
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
|
Side Effects PACU
Incidence of nausea, vomiting, pruritus, constipation reported in the PACU by patient
|
|---|---|---|
|
Deviation From Prescribed Oral Pain Regimen
Lost to Follow up
|
1 Participants
|
—
|
|
Deviation From Prescribed Oral Pain Regimen
Protocol Deviations
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: PACU, Postoperative day 1Population: Patients who answer yes to side effects in the past 24hr for POD1
Incidence of nausea, vomiting, pruritus (itching), and constipation. These are reported by the patient in the PACU and on postoperative day 1
Outcome measures
| Measure |
Postoperative Acupuncture
n=41 Participants
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
|
Side Effects PACU
n=41 Participants
Incidence of nausea, vomiting, pruritus, constipation reported in the PACU by patient
|
|---|---|---|
|
Number of Participants With Side Effects on POD1 and During the PACU Stay
General fatigue/weaknesses
|
7 participants
|
6 participants
|
|
Number of Participants With Side Effects on POD1 and During the PACU Stay
Nausea
|
11 participants
|
7 participants
|
|
Number of Participants With Side Effects on POD1 and During the PACU Stay
Vomiting
|
4 participants
|
0 participants
|
|
Number of Participants With Side Effects on POD1 and During the PACU Stay
Constipation
|
3 participants
|
0 participants
|
|
Number of Participants With Side Effects on POD1 and During the PACU Stay
Difficulty passing urine
|
2 participants
|
3 participants
|
|
Number of Participants With Side Effects on POD1 and During the PACU Stay
Concentrating
|
2 participants
|
1 participants
|
|
Number of Participants With Side Effects on POD1 and During the PACU Stay
Drowsy/staying awake
|
8 participants
|
9 participants
|
|
Number of Participants With Side Effects on POD1 and During the PACU Stay
Lightheaded or Dizzy
|
8 participants
|
9 participants
|
|
Number of Participants With Side Effects on POD1 and During the PACU Stay
Confused
|
2 participants
|
0 participants
|
|
Number of Participants With Side Effects on POD1 and During the PACU Stay
Itchiness
|
4 participants
|
0 participants
|
|
Number of Participants With Side Effects on POD1 and During the PACU Stay
Dry mouth
|
15 participants
|
16 participants
|
|
Number of Participants With Side Effects on POD1 and During the PACU Stay
Headache
|
7 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 weeks postoperative (surgeon office visit)Population: 6 weeks post-op follow up. Only 5 patients completed this secondary measure.
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)
Outcome measures
| Measure |
Postoperative Acupuncture
n=5 Participants
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
|
Side Effects PACU
Incidence of nausea, vomiting, pruritus, constipation reported in the PACU by patient
|
|---|---|---|
|
Postoperative Range of Motion
|
113.2 degrees
Standard Deviation 20.5
|
—
|
SECONDARY outcome
Timeframe: IntraoperativelyPopulation: Length of time for tourniquet inflated during the intra-operative. 5 patients out of 41 did not have tourniquets.
Duration of time the tourniquet is inflated intraoperatively. Measured in minutes
Outcome measures
| Measure |
Postoperative Acupuncture
n=36 Participants
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
|
Side Effects PACU
Incidence of nausea, vomiting, pruritus, constipation reported in the PACU by patient
|
|---|---|---|
|
Tourniquet Time
|
60.5 minutes
Standard Deviation 11.7
|
—
|
Adverse Events
Postoperative Acupuncture
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place