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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：
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| whole-process transcutaneous electrical acupoint stimulation | Experimental | 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. |
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| whole-process transcutaneous electrical acupoint stimulation(sham stimulation) | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcutaneous electrical acupoint stimulation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The total sufentanil consumption postoperatively | measured from the recovery area until postoperative day 3 | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| The number of postoperative rescue analgesia | measured from the recovery area until discharge | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guoxin Li, M.D.,Ph.D. | Contact | +86 13802771450 | gzliguoxin@163.com | |
| Fang Qin, MS.N. | Contact | +86 15018410013 | qf_smu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Guoxin Li, M.D.,Ph.D. | Nanfang Hospital, Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital, Southern Medical University | Recruiting | Guangzhou | Guangdong | 510-515 | China |
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| transcutaneous electrical acupoint stimulation sham stimulation | Other | 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. |
|
| 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. | 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. | 5 days |
| The variation of C-reactive protein（CRP） | the values of C-reactive protein from peripheral blood | 3 days |
| Procalcitonin（PCT） | the values of procalcitonin from peripheral blood | 3 days |
| The variation of white blood cell count （WBC） | the values of white blood cell count from peripheral blood | 3 days |
| Neutrophil ratio（NEUT） | neutrophil ratio from peripheral blood | 3 days |
| Time to first ambulation | time to first ambulation in hours is used | up to 7 days |
| Time to first flatus | time to first flatus in hours is used | up to 7 days |
| Time to first defecation | time to first defecation in hours is used | 7 days |
| Time to first feed | time to first feed in hours is used | up to 7 days |
| The incidence rate of adverse reaction | adverse reaction includes PONV、abdominal distension、 diarrhea、difficult defecation ect. | 7 days |
| Satisfaction score with pain management | measured by 5-point Likert scale, "1" represents very dissatisfied while "5" represents very satisfied | 7 days |