Acupuncture for Low-Dose Opioid for TKA Replacement

• Sponsor: Hospital for Special Surgery, New York (Other)
• Overall Status: Completed
• CT.gov ID: NCT04084288
• Collaborator: (none)
• Enrollment: 41
• Location: 1
• Arm: 1
• Actual Duration (Months): 13.4
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis; Pain, Postoperative; Acupuncture	Other: Acupuncture; Device: Peripheral Nerve Stimulator	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 41 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Intraoperative Acupuncture for Low-Dose Opioid Total Knee Replacement: An Observational Prospective Cohort Study
• Actual Study Start Date: Aug 21, 2019
• Actual Primary Completion Date: Oct 2, 2020
• Actual Study Completion Date: Oct 2, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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)

Other: 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; Device: Peripheral Nerve Stimulator; 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).

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

2. 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.

3. Duration of Neuraxial Anesthesia in Hours [postoperative day 1]

4. 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

5. 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

6. 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)

7. Tourniquet Time [Intraoperatively]

   Duration of time the tourniquet is inflated intraoperatively. Measured in minutes

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital for Special Surgery	New York	New York	United States	10021

Sponsors and Collaborators

• Hospital for Special Surgery, New York

Investigators

• Principal Investigator: Stephanie Cheng, MD, Hospital for Special Surgery, New York

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 24, 2020

More Information

Publications

None provided.

• Responsible Party: Hospital for Special Surgery, New York
• ClinicalTrials.gov Identifier: NCT04084288
• Other Study ID Numbers: 2019-1193
• First Posted: Sep 10, 2019
• Last Update Posted: May 5, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Hospital for Special Surgery, New York: Acupuncture, Total Knee Replacement
• Additional relevant MeSH terms: Osteoarthritis, Knee; Pain, Postoperative

Study Results

Participant Flow

Arm/Group Title	Postoperative Acupuncture
Arm/Group Description	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
Period Title: Overall Study
STARTED	41
COMPLETED	41
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Postoperative Acupuncture
Arm/Group Description	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 Participants	41
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.9 (7)
Sex: Female, Male (Count of Participants)
Female	21 51.2%
Male	20 48.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 4.9%
Not Hispanic or Latino	39 95.1%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	3 7.3%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 4.9%
White	34 82.9%
More than one race	0 0%
Unknown or Not Reported	2 4.9%
Region of Enrollment (participants) [Number]
United States	41 100%

Outcome Measures

1. Primary Outcome

Title	Low-dose Opioid Regimen Adherence
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Postoperative Acupuncture
Arm/Group Description	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
Measure Participants	41
Number [participants]	26 63.4%

2. Secondary Outcome

Title	Total Opioid Consumption
Description	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

Outcome Measure Data

Analysis Population Description

One patient lost to follow-up on POD1.

Arm/Group Title	Postoperative Acupuncture
Arm/Group Description	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
Measure Participants	41
PACU	14.9 (12.4)
POD1	11.9 (20)
POD2	7.3 (15.5)
POD7	13.5 (55.7)
POD14	108.3 (190.4)
POD30	0 (0)

3. Secondary Outcome

Title	Numerical Rating Scale (NRS) Pain Scores at Rest and With Movement
Description	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

Outcome Measure Data

Analysis Population Description

One patient lost to follow-up on POD1. Some patients were not available for administration of NRS at all time points.

Arm/Group Title	Postoperative Acupuncture
Arm/Group Description	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
Measure Participants	41
Pre-Op	5.1 (2.2)
POD0	4.2 (2.7)
POD1	3.7 (2)
POD7	3.7 (2.2)
POD14	3 (1.8)
POD30	2.4 (1.9)

4. Secondary Outcome

Title	Duration of Neuraxial Anesthesia in Hours
Time Frame	postoperative day 1

Outcome Measure Data

Analysis Population Description

Duration of neuraxial anesthesia in hours

Arm/Group Title	Postoperative Acupuncture
Arm/Group Description	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
Measure Participants	41
Mean (Standard Deviation) [Hours]	2.6 (0.3)

5. Secondary Outcome

Title	Deviation From Prescribed Oral Pain Regimen
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Postoperative Acupuncture
Arm/Group Description	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. 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 Peripheral Nerve Stimulator: 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).
Measure Participants	41
Lost to Follow up	1 2.4%
Protocol Deviations	0 0%

6. Secondary Outcome

Title	Number of Participants With Side Effects on POD1 and During the PACU Stay
Description	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

Outcome Measure Data

Analysis Population Description

Patients who answer yes to side effects in the past 24hr for POD1

Arm/Group Title	Side Effects in the Past 24 hs POD 1	Side Effects PACU
Arm/Group Description	for POD 1, In the last 24 hours, have you had any nausea, vomiting, constipation, difficulty passing urine, concentrating, staying awake, lightheaded/dizzy, confused, general fatigue, itchiness, dry mouth, headache?	Incidence of nausea, vomiting, pruritus, constipation reported in the PACU by patient
Measure Participants	41	41
Nausea	11 26.8%	7 NaN
Vomiting	4 9.8%	0 NaN
Constipation	3 7.3%	0 NaN
Difficulty passing urine	2 4.9%	3 NaN
Concentrating	2 4.9%	1 NaN
Drowsy/staying awake	8 19.5%	9 NaN
Lightheaded or Dizzy	8 19.5%	9 NaN
Confused	2 4.9%	0 NaN
General fatigue/weaknesses	7 17.1%	6 NaN
Itchiness	4 9.8%	0 NaN
Dry mouth	15 36.6%	16 NaN
Headache	7 17.1%	0 NaN

7. Secondary Outcome

Title	Postoperative Range of Motion
Description	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)

Outcome Measure Data

Analysis Population Description

6 weeks post-op follow up. Only 5 patients completed this secondary measure.

Arm/Group Title	Knee Range of Motion (ROM) at 6 Weeks
Arm/Group Description	Range of motion at 6 weeks F/U for surgery
Measure Participants	5
Mean (Standard Deviation) [degrees]	113.2 (20.5)

8. Secondary Outcome

Title	Tourniquet Time
Description	Duration of time the tourniquet is inflated intraoperatively. Measured in minutes
Time Frame	Intraoperatively

Outcome Measure Data

Analysis Population Description

Length of time for tourniquet inflated during the intra-operative. 5 patients out of 41 did not have tourniquets.

Arm/Group Title	Tourniquet Intra-operative
Arm/Group Description	Length of tourniquet time during intra-operative
Measure Participants	36
Mean (Standard Deviation) [minutes]	60.5 (11.7)

Adverse Events

Time Frame	The duration of patient enrollment (1 year)
Arm/Group Title	Postoperative Acupuncture
Arm/Group Description	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
All Cause Mortality
	Postoperative Acupuncture
	Affected / at Risk (%)	# Events
Total	0/41 (0%)
Serious Adverse Events
	Postoperative Acupuncture
	Affected / at Risk (%)	# Events
Total	0/41 (0%)
Other (Not Including Serious) Adverse Events
	Postoperative Acupuncture
	Affected / at Risk (%)	# Events
Total	0/41 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.