NCT06024200

Transcutaneous Electrical Acupoint Stimulation for Opioid Consumption After Gastrointestinal Laparoscopic Surgery

Effect of Whole-process Transcutaneous Electrical Acupoint Stimulation on Opioid Consumption After Gastrointestinal Laparoscopic Surgery: a Prospective, Randomised, Blinded, Placebo-controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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 The pump was withdrawn 72h after surgery. 3.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.

Conditions

• Transcutaneous Electrical Acupoint Stimulation

Interventions

Type	Name	Description
OTHER	transcutaneous electrical acupoint stimulation	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.
OTHER	transcutaneous electrical acupoint stimulation sham stimulation	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.

Timeline

• Start date: 2023-06-02
• Primary completion: 2023-10-30
• Completion: 2024-01-30
• First posted: 2023-09-06
• Last updated: 2023-09-11

Locations

1 site across 1 country: China