Acupuncture ACL (Anterior Cruciate Ligament)

Anesthesia Clinical Trial

Official title:

Feasibility of Electro Auricular Acupuncture for Analgesia After ACL Surgery: The Feasibility of Patient Blinding and Effects on Early Postoperative Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03711734
• Other study ID #: 2018-1478
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: December 13, 2019

Study information

• Verified date: November 2023
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 13, 2019
• Est. primary completion date: December 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• ACL
• ACL Injury
• Anesthesia
• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Injury
• Anterior Cruciate Ligament Rupture
• Rupture
• Wounds and Injuries

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	postoperative day 1
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.	postoperative day 1
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.	postoperative day 1
Secondary	Opioid Consumption	Measured in cumulative oral morphine equivalent. Each patient measured individually and then all patients' measurement was averaged.	day of surgery through postoperative day 1