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
Verified date | November 2023 |
Source | Hospital for Special Surgery, New York |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
United States | Hospital for Special Surgery | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Hospital for Special Surgery, New York |
United States,
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 |
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