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Acupuncture ACL (Anterior Cruciate Ligament)

Not Applicable
Completed
Conditions
Anesthesia
ACL
Anterior Cruciate Ligament Injury
Anterior Cruciate Ligament Rupture
ACL Injury
Interventions
Other: Acupuncture + Standard of Care
Registration Number
NCT03711734
Lead Sponsor
Hospital for Special Surgery, New York
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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Acupuncture + Standard of CareAcupuncture + Standard of CarePatients 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.
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
Numeric Rating Scale (NRS) Pain With Movement Scorespostoperative 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 Consumptionday of surgery through postoperative day 1

Measured in cumulative oral morphine equivalent. Each patient measured individually and then all patients' measurement was averaged.

Numeric Rating Scale (NRS) Pain at Rest Scorespostoperative 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.

Trial Locations

Locations (1)

Hospital for Special Surgery

🇺🇸

New York, New York, United States

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