Patients were randomly and equally grouped into sham control (n = 188), single acupoint (PC6, n = 198), or combined acupoints (PC6 and CV17, n = 190) TEAS groups using a centralized computer-generated randomization system. TEAS was applied for 30 min before anesthesia induction. The sham-operated control group received electrode attachment but without stimulation.
Sample Count
576
Age
18-65
Control
Sham
sham control(n = 188)
Experiment
single acupoint(n=198);combined acupoints(n=190)
Indicator
Incidence of chronic pain 6 months after surgeryRemifentanil consumptionTime to the first verbal responseTime to endotracheal extubationPostoperative Nausea and Vomiting(PONV)Respiratory depressionNumeric rating scale(NRS)Demand for rescue analgesicsPatient satisfaction scores on analgesia by 24 h after surgeryIncidence of chronic pain at 3 months after surgery
Auxiliary Medication
All surgical procedures were performed under total intravenous anesthesia with endotracheal intubation. Anesthesia was induced with midazolam, propofol, and fentanyl, and continuous infusion of remifentanil and propofol was titrated to maintain a Narcotrend index of 40-60 and stable hemodynamics. After endotracheal extubation, the patients were transferred to the post-anesthesia care unit. Forty milligrams of parecoxib sodium was administered before the incision. Sufentanil was used for patient-controlled analgesia after surgery. Parecoxib sodium (40 mg) was administered as rescue analgesia for those whose NRS was higher than 4.
Stimulation Method
TEAS
Induction Method
Electroacupuncture Instrument Model
Manufacturer
Frequency
Waveform
Strength
Induction Time
Hwato SDZ-V
Hwato,Suzhou Medical Appliances Co., Ltd., Suzhou, China
2/10 Hz
disperse-dense wave
The stimulation intensity was identified as the maximal tolerance to the “Teh Chi” sensations of heaviness, numbness, and swelling at the point of stimulation.
30 min
Acupuncture_Needle
Needle_Manufacturer
Needle_Depth
-
-
-
Description Briefly, electrodes were attached to the skin surface of the acupoint and connected to the Hwato Electric Acupuncture Treatment Instrument by leads (model No. SDZ-V; Suzhou Medical Appliances Co., Ltd., Suzhou, China; see Supplemental Material 1). Patients in the combined acupoints group received TEAS at bilateral PC6 (Neiguan, a key acupoint of the hand-jueyin pericardium meridian) and CV17 (Danzhong, a key acupoint of the Ren meridian). Patients in the single acupoint group received TEAS at the bilateral PC6 acupoints (see Supplemental Material 1). The device provided “disperse-dense” waves with alternating frequencies of 2 Hz and 10 Hz for two cycles. The stimulation intensity was identi ed as the maximal tolerance to the “Teh Chi” sensations of heaviness, numbness, and swelling at the point of stimulation. Anesthesia induction was initiated after 30 min of TEAS.
Anesthesia Method
AAA
Clinical Trial Type
A multicenter randomized clinical trial
Adverse Effects
One patient in the single acupoint group reported discomfort in the skin area attached to the electrodes. No differences were found among the three groups.
Contraindications
Scar or skin damage at the stimulation site, electronic devices such as pacemakers or other implanted medical electronic devices in the body
Effector
Of the 576 randomized patients, 568 completed the trial. In the intention-to-treat analysis, post-mastectomy pain at 6 months was reported in 42 of 190 patients (22.1%) in the combined acupoints group, 65 of 188 patients (34.6%) in the sham-operated group (P = 0.007; relative risk [RR], 95% con dence interval [CI]: 0.68, 0.52–0.89), and 72 of 198 patients (36.4%) in the single acupoint group (P = 0.002; RR, 95% CI: 0.72, 0.55–0.93). Remifentanil consumption during surgery and postoperative nausea and vomiting at 24 h after surgery were lower in the combined acupoint group than that in the sham-operated group. TEAS at combined acupoints before surgery was associated with reduced chronic pain 6 months after surgery.
Transcutaneous electrical acupoint stimulation before surgery reduces chronic pain after mastectomy: A randomized clinical trial.
Abstract
STUDY OBJECTIVE: Despite multiple interventions, the incidence of chronic pain after mastectomy could be as high as 50% after surgery. This study aimed to determine the efficacy of transcutaneous electrical acupoint stimulation (TEAS) before anesthesia induction in reducing chronic pain and to compare the effect of combined acupoint TEAS with that of single acupoint TEAS. DESIGN: A multicenter randomized clinical trial. SETTING: The study was conducted at six medical centers in China from May 2016 to April 2018. Final follow-up was on October 26, 2018. PARTICIPANTS: Eligible patients were women scheduled for radical mastectomy under general anesthesia. INTERVENTIONS: Patients were randomly and equally grouped into sham control (n = 188), single acupoint (PC6, n = 198), or combined acupoints (PC6 and CV17, n = 190) TEAS groups using a centralized computer-generated randomization system. TEAS was applied for 30 min before anesthesia induction. The sham-operated control group received electrode attachment but without stimulation. Anesthesiologists, surgeons, and outcome assessors were blinded to the interventions. MEASURES: The primary endpoint was the incidence of chronic pain 6 months after surgery. Incidences were compared among the groups using the unadjusted chi(2) test. RESULTS: Of the 576 randomized patients, 568 completed the trial. In the intention-to-treat analysis, post-mastectomy pain at 6 months was reported in 42 of 190 patients (22.1%) in the combined acupoints group, 65 of 188 patients (34.6%) in the sham-operated group (P = 0.007; relative risk [RR], 95% confidence interval [CI]: 0.68, 0.52-0.89), and 72 of 198 patients (36.4%) in the single acupoint group (P = 0.002; RR, 95% CI: 0.72, 0.55-0.93). Remifentanil consumption during surgery and postoperative nausea and vomiting at 24 h after surgery were lower in the combined acupoint group than that in the sham-operated group. CONCLUSION: TEAS at combined acupoints before surgery was associated with reduced chronic pain 6 months after surgery. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02741726. Registered on April 13, 2016."
