Clinical trial NCT03711734: Acupuncture ACL (Anterior Cruciate Ligament)
Official title: Feasibility of Electro Auricular Acupuncture for Analgesia After ACL Surgery: The Feasibility of Patient Blinding and Effects on Early Postoperative Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ACL
ACL Injury
Anterior Cruciate Ligament Injury
Anterior Cruciate Ligament Rupture
Anesthesia
Keywords: Acupuncture
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2018-10-18
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Eligibility criteria: 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)

Primary outcomes:
measure: Bang Blinding Index (BI)
timeFrame: postoperative day 1
Secondary outcomes:
measure: Numeric Rating Scale (NRS) Pain at Rest Scores
timeFrame: postoperative day 1
measure: Numeric Rating Scale (NRS) Pain With Movement Scores
timeFrame: postoperative day 1
measure: Opioid Consumption
timeFrame: day of surgery through postoperative day 1
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgey
name: Stephanie Cheng, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cheng SI, Norman RM, DeMeo D, Zhong H, Turteltaub LH, McCarthy MM, Marx RG, Strickland SM, Kelly AM. The Feasibility of Blinding Intraoperative Electro-Auricular Acupuncture Under Neuraxial Anesthesia. Med Acupunct. 2021 Aug 1;33(4):286-294. doi: 10.1089/acu.2021.0003. Epub 2021 Aug 17.