Acupuncture ACL (Anterior Cruciate Ligament)

Hospital for Special Surgery (HSS)

Status: Completed

Conditions: ACL; Anterior Cruciate Ligament Injury; Anterior Cruciate Ligament Rupture; ACL Injury; Anesthesia

Treatments: Other: Acupuncture + Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT03711734

2018-1478

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 patients

Sex: All

Ages: 12 to 80 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Acupuncture + Standard of Care

Experimental group

Description:

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.

Treatment:

Other: Acupuncture + Standard of Care

No acupuncture + Standard of Care

No Intervention group

Description:

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.