ACL, ACL Injury, Anesthesia, Anterior Cruciate Ligament Injury, Anterior Cruciate Ligament Rupture
Conditions
Keywords
Acupuncture
Brief summary
Acupuncture research in regards to PONV has been fairly well established, however, studies about perioperative pain control and acupuncture are a little more murky. In 2008, a meta analysis looked at randomized controlled studies and found that while acupuncture was shown to decrease pain, there were limitations including credible placebo or sham intervention, and thus, blinding. The main purpose of this feasibility trial is to determine whether or not adequate blinding is possible in the intraoperative setting with the patient sedated.
Detailed description
According to the most recent survey conducted by the national center for complementary and integrative health (a branch of the National Institutes of Health) in 2007, the use of complementary alternative medicine (CAM) has increased significantly from 2002 (the previous survey). In the 2007 survey, in the United States alone, 38% percent of adults and 12% of children use some form of CAM. It has been 10 years since that survey report, there is little doubt that these numbers have only increased. According to the National Center for Health Statistics on the expenditures on CAM in 2012 - for just adults utilizing specialists, such as acupuncturists, $14.1 Billion was spent. With this increasing demand of such treatment modalities by patients, conventional practitioners will need to be, at the very least, well versed enough to recommend for or against these modalities. In addition, the current opioid epidemic is on the forefront of the public mind. Recently declared a public health emergency by the President, alternative means of postoperative pain control is a necessity and integrative medicine is a low cost, safe, and effective adjuvant/alternative
Interventions
OTHERAcupuncture + Standard of Care
Acupuncture is a nonpharmacologic pain management modality that has been shown to provide superior analgesia for acute pain. This will be combined with our facility's standard of care anesthesia and pain management plan.
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients undergoing ACL Surgery with a participating surgeon * English Speaking * Patients at least 12 years old * Planned spinal anesthesia without peripheral nerve block (rescue block is okay)
Exclusion criteria
* Patients under the age of 12 * Non-English speaking patients * Patients planning on having general anesthesia * Planned preop peripheral nerve block * Patients with the inability to understand/follow study protocol * Patients with pacemaker/AICD * Non-native Ear/Previous scarring/surgical manipulation of ear * Patients with contraindications to intra-op protocol * Chronic pain patients * Patients who have regularly used opioids for more than 6 weeks prior to surgery * Patients with guages in their ears * Patients who refuse to remove earrings/piercings prior to surgery * Patients with nickel allergies (needles are made of nickel)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bang Blinding Index (BI) | postoperative day 1 | Patients' ability to determine whether or not they received acupuncture. The success of patient blinding in each group will be quantified using Bang Blinding Index (BI) which ranges from min = -1 to max = 1. Scores closest to 0 indicate a less likelihood that patients were able to guess which group they were randomized into. A score of 1 or -1 means that patients were able to guess which group they were in. This value is obtained by asking patients which group they believe they were randomly assigned to. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale (NRS) Pain at Rest Scores | postoperative day 1 | Numeric Rating Scale (NRS) pain at rest on a scale of 0 (no pain) to 10 (worst pain ever imaginable). A lower score is a better outcome. |
| Numeric Rating Scale (NRS) Pain With Movement Scores | postoperative day 1 | Numeric Rating Scale (NRS) pain with movement on a scale of 0 (no pain) to 10 (worst pain imaginable). A lower score is a better outcome. |
| Opioid Consumption | day of surgery through postoperative day 1 | Measured in cumulative oral morphine equivalent. Each patient measured individually and then all patients' measurement was averaged. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Acupuncture + Standard of Care Patients will receive spinal anesthesia (4 cc Mepivacaine) with IV sedation. Intraoperative anti-emetics will consist of IV odansetron and IV dexamethasone. Intra-operative analgesics will include IV Ketamine, IV Ketorolac, and IV Acetaminophen.
Patients will have ATP acupuncture (8 ear points - Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) bilaterally with electrostimulation at Shen men and Hypothalamus at 30 hz.
Acupuncture + Standard of Care: Acupuncture is a nonpharmacologic pain management modality that has been shown to provide superior analgesia for acute pain. This will be combined with our facility's standard of care anesthesia and pain management plan. | 20 |
| No Acupuncture + Standard of Care Patients will receive spinal anesthesia (4 cc Mepivacaine) with IV sedation. Intraoperative anti-emetics will consist of IV odansetron and IV dexamethasone. Intra-operative analgesics will include IV Ketamine, IV Ketorolac, and IV Acetaminophen.
Patients will not have ATP acupuncture (8 ear points - Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) bilaterally. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Acupuncture + Standard of Care | Total | No Acupuncture + Standard of Care |
|---|---|---|---|
| Age, Continuous | 34 years STANDARD_DEVIATION 11.1 | 32 years STANDARD_DEVIATION 12.1 | 29.8 years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 34 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 8 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) White | 13 Participants | 24 Participants | 11 Participants |
| Region of Enrollment United States | 20 participants | 40 participants | 20 participants |
| Sex: Female, Male Female | 10 Participants | 21 Participants | 11 Participants |
| Sex: Female, Male Male | 10 Participants | 19 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Bang Blinding Index (BI)
Patients' ability to determine whether or not they received acupuncture. The success of patient blinding in each group will be quantified using Bang Blinding Index (BI) which ranges from min = -1 to max = 1. Scores closest to 0 indicate a less likelihood that patients were able to guess which group they were randomized into. A score of 1 or -1 means that patients were able to guess which group they were in. This value is obtained by asking patients which group they believe they were randomly assigned to.
Time frame: postoperative day 1
Population: One patient was lost to follow up.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acupuncture + Standard of Care | Bang Blinding Index (BI) | 0.2 score on a scale |
| No Acupuncture + Standard of Care | Bang Blinding Index (BI) | 0.11 score on a scale |
Secondary
Numeric Rating Scale (NRS) Pain at Rest Scores
Numeric Rating Scale (NRS) pain at rest on a scale of 0 (no pain) to 10 (worst pain ever imaginable). A lower score is a better outcome.
Time frame: postoperative day 1
Population: One patient was lost to follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture + Standard of Care | Numeric Rating Scale (NRS) Pain at Rest Scores | 4.3 score on a scale | Standard Deviation 1.8 |
| No Acupuncture + Standard of Care | Numeric Rating Scale (NRS) Pain at Rest Scores | 4.1 score on a scale | Standard Deviation 1.9 |
Secondary
Numeric Rating Scale (NRS) Pain With Movement Scores
Numeric Rating Scale (NRS) pain with movement on a scale of 0 (no pain) to 10 (worst pain imaginable). A lower score is a better outcome.
Time frame: postoperative day 1
Population: Some patients were lost to follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture + Standard of Care | Numeric Rating Scale (NRS) Pain With Movement Scores | 5.2 score on a scale | Standard Deviation 1.9 |
| No Acupuncture + Standard of Care | Numeric Rating Scale (NRS) Pain With Movement Scores | 4.6 score on a scale | Standard Deviation 1.9 |
Secondary
Opioid Consumption
Measured in cumulative oral morphine equivalent. Each patient measured individually and then all patients' measurement was averaged.
Time frame: day of surgery through postoperative day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acupuncture + Standard of Care | Opioid Consumption | 47.8 oral morphine equivalent | Standard Deviation 34.6 |
| No Acupuncture + Standard of Care | Opioid Consumption | 46.3 oral morphine equivalent | Standard Deviation 25.3 |