Transcutaneous Electrical Acupoint Stimulation for Opioid Consumption After Gastrointestinal Laparoscopic Surgery

Not Applicable

Recruiting

• Conditions: Transcutaneous Electrical Acupoint Stimulation

• Registration Number: NCT06024200
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief 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 The pump was withdrawn 72h after surgery.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.

Study Timeline

• Study Start: 2023-06-02
• Study First Submitted: 2023-08-16
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-05
• Study First Posted: 2023-09-06
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-11
• Primary Completion: 2023-10-30
• Study Completion: 2024-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The total sufentanil consumption postoperatively	3 days	measured from the recovery area until postoperative day 3

Secondary Outcome Measures

Name	Time	Method
Neutrophil ratio（NEUT）	3 days	neutrophil ratio from peripheral blood
The number of postoperative rescue analgesia	7 days	measured from the recovery area until discharge
Pain scores (VAS)	4 days	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.
Pain Catastrophizing	5 days	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.
Quality of recovery	5 days	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.
The variation of C-reactive protein（CRP）	3 days	the values of C-reactive protein from peripheral blood
The variation of white blood cell count （WBC）	3 days	the values of white blood cell count from peripheral blood
Time to first ambulation	up to 7 days	time to first ambulation in hours is used
Satisfaction score with pain management	7 days	measured by 5-point Likert scale, "1" represents very dissatisfied while "5" represents very satisfied
Procalcitonin（PCT）	3 days	the values of procalcitonin from peripheral blood
Time to first flatus	up to 7 days	time to first flatus in hours is used
Time to first defecation	7 days	time to first defecation in hours is used
Time to first feed	up to 7 days	time to first feed in hours is used
The incidence rate of adverse reaction	7 days	adverse reaction includes PONV、abdominal distension、 diarrhea、difficult defecation ect.

Trial Locations

Locations (1)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China