Transcutaneous Electrical Acupoint Stimulation for Opioid Consumption After Gastrointestinal Laparoscopic Surgery

Nanfang Hospital, Southern Medical University

Status: Enrolling

Conditions: Transcutaneous Electrical Acupoint Stimulation

Treatments: Other: transcutaneous electrical acupoint stimulation sham stimulation; Other: transcutaneous electrical acupoint stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06024200

NFEC-2023-327

Details and patient eligibility

About

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.

Full description

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 The pump was withdrawn 72h after surgery.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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• aged 18 years or older;
• scheduled for elective laparoscopic gastrointestinal surgery；
• informed consent；
• American Society of Anesthesiologists Physical Status Grades I-III；
• body mass index (BMI) between 18.5 kg/m2 and 28 kg/m2

Exclusion criteria

• local skin infection, incision or scar near the study acupoints;
• nerve damage in upper or lower limbs;
• participation in other clinical trials that influence the evaluation of the results of this study;
• inability to understand the Visual Analog Scale (VAS) score or disagreeing with the use of patient controlled analgesia;
• presence of a pacemaker;
• patients with severe CNS diseases or severe mental disorders;
• operations requiring enterostomy or converts to laparotomy;
• patients who need to be transferred to the intensive care unit (ICU) for treatment after surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

128 participants in 2 patient groups

whole-process transcutaneous electrical acupoint stimulation

Experimental group

Description:

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.

Treatment:

Other: transcutaneous electrical acupoint stimulation

whole-process transcutaneous electrical acupoint stimulation(sham stimulation)

Sham Comparator group

Description:

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.

Treatment:

Other: transcutaneous electrical acupoint stimulation sham stimulation