The goal of this clinical trial is to evaluate the effect of whole-process transcutaneous electrical acupoint stimulation on opioid consumption after gastrointestinal laparoscopic surgery. All subjects received conventional multimodal analgesia. On this basis, the experimental group received whole-process transcutaneous electrical acupoint stimulation, while the control group received corresponding false stimulation.
Conventional multimodal analgesia protocols as follows： 1. Before the end of the operation, the surgical incision was infiltrated with 0.5% ropivacaine 10 mL locally. 2. Patients were transferred to the PACU and provided with patient-controlled intravenous analgesia with sufentanil for postoperative analgesia. The analgesia devices were set to a concentration of 1ug/mL, with a lockout interval of 15 minutes, and a 3 mL bolus，without an infusion dose. The pump was withdrawn 72h after surgery. 3. Flurbiprofen: 50mg per dose intravenously twice a day for postoperative three days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
128
Electrical stimulation is performed within 24h before surgery, 30min before anesthesia induction and 3 days after surgery, each stimulation was 30min. Patients are treated bilaterally at two groups of distal acupoints: one group consisted of Hegu (LI4) and Neiguan (PC6), the other contained Zusanli (ST36) and Shanyinjiao (SP6). Stimulation is delivered with adisperse-dense wave, 2Hz in frequency. The stimulation intensity is adjusted in accordance with the maximal level tolerated by each patient.
Patients are treated bilaterally at four sham acupoints of LI4, PC6, ST36 and SP6. These four pseudo-acupoints were located 1 cun ulnarlateral, and 7 cun and 9 cun proximal to Shenmen (HT7) ;and 9 cun and 12 cun proximal of Kunlun (BL60). These sham points are picked because there are no meridians or channels through these four sites. The stimulation intensity is adjusted in the lowest level felt by each patient. Other intervention details are similar to those of the experimental group.
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGThe total sufentanil consumption postoperatively
measured from the recovery area until postoperative day 3
Time frame: 3 days
The number of postoperative rescue analgesia
measured from the recovery area until discharge
Time frame: 7 days
Pain scores (VAS)
measured by Visual Analogue Scale( VAS ), which is a scale created in the range of 0 to 10 cm. According to the scale, 0 cm means no pain, and 10 cm means unbearable pain. On the scale, 1 to 3 cm indicates mild pain, 4 to 6 cm indicates moderate pain, and 7 to 10 cm indicates severe pain.
Time frame: 4 days
Pain Catastrophizing
measured by Pain Catastrophizing Scale（PCS）, which contains 13 items in three dimensions: rumination, magnification, and helplessness. Patients can answer on a 0-to-4 likert scale (0 = "not at all" and 4 = "all the time"). PCS scores range from 0 to 52, and the higher the score,the higher the frequency of catastrophizing cognitions.
Time frame: 5 days
Quality of recovery
measured by Quality of Recovery (QoR)-15 questionnaire, which consists of 15 questions distributed on two dimensions: "physical" and "mental" well-being. The patients report their experiences on a scale from 0 (=not at all) to 10 (=all the time), where negatively loaded questions are reversed. This gives a maximum score = 150.
Time frame: 5 days
The variation of C-reactive protein（CRP）
the values of C-reactive protein from peripheral blood
Time frame: 3 days
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Procalcitonin（PCT）
the values of procalcitonin from peripheral blood
Time frame: 3 days
The variation of white blood cell count （WBC）
the values of white blood cell count from peripheral blood
Time frame: 3 days
Neutrophil ratio（NEUT）
neutrophil ratio from peripheral blood
Time frame: 3 days
Time to first ambulation
time to first ambulation in hours is used
Time frame: up to 7 days
Time to first flatus
time to first flatus in hours is used
Time frame: up to 7 days
Time to first defecation
time to first defecation in hours is used
Time frame: 7 days
Time to first feed
time to first feed in hours is used
Time frame: up to 7 days
The incidence rate of adverse reaction
adverse reaction includes PONV、abdominal distension、 diarrhea、difficult defecation ect.
Time frame: 7 days
Satisfaction score with pain management
measured by 5-point Likert scale, "1" represents very dissatisfied while "5" represents very satisfied
Time frame: 7 days