The Feasibility of Blinding Intraoperative Electro-Auricular Acupuncture under Neuraxial Anesthesia

Abstract

Objective: Demand for complementary medicine, in particular, acupuncture, has increased over the past few years but widespread acceptance has been limited, in part, by the lack of high-quality studies, including lack of blinding. Acupuncture studies traditionally have difficulty with blinding as sham acupuncture can have up to a 40%-50% analgesic effect. This study randomized patients between Acupuncture and No Acupuncture (standard of care) without using sham needles. The primary outcome was adequate blinding of electro-auricular acupuncture in the intraoperative setting with secondary outcomes of pain/nausea control. Materials and Methods: Forty patients undergoing anterior cruciate ligament reconstruction were enrolled. Subjects were randomly assigned to receive acupuncture (Enhanced Electro-Auricular Trauma Protocol) or No Acupuncture during their surgeries. All patients received spinal anesthesia and intravenous midazolam, ketamine, and propofol for sedation. 1000 mg of intravenous (IV) acetaminophen and up to 30 mg of IV ketorolac were given at closure. No opioids or peripheral nerve blocks were administered intraoperatively. Results: Bang's Blinding indices were 0.2 (95% confidence interval [CI]:-0.02, 0.42) in the Acupuncture group, and 0.11 (95% CI:-0.10, 0.31) in the No Acupuncture group on postoperative day 1. Both groups had adequate blinding. There were no differences in pain scores, nausea/vomiting incidence, opioid consumption 0-24 hours, or patient satisfaction. Five patients in the No Acupuncture group received rescue blocks, while no patients in the Acupuncture group needed a rescue block (Fisher's exact test: P = 0.047). Conclusions: This study proved the primary hypothesis that adequate blinding of intraoperative acupuncture can be performed when patients are under sedation and neuraxial anesthesia. This research is registered at ClinicalTrials.gov as Clinical Trial Registration #: NCT03711734.