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

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.

Study Overview

• Status: Recruiting
• Conditions: Transcutaneous Electrical Acupoint Stimulation
• Intervention / Treatment: Other: transcutaneous electrical acupoint stimulation; Other: transcutaneous electrical acupoint stimulation sham 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 The pump was withdrawn 72h after surgery.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 Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guoxin Li, M.D.,Ph.D.; Phone Number: +86 13802771450; Email: gzliguoxin@163.com
• Study Contact Backup: Name: Fang Qin, MS.N.; Phone Number: +86 15018410013; Email: qf_smu@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510-515
      • Recruiting
      • Nanfang Hospital, Southern Medical University
      • Contact: Guoxin Li, M.D.,Ph.D.; Phone Number: +8613802771450; Email: gzliguoxin@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: whole-process 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; 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.
Sham Comparator: whole-process 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total sufentanil consumption postoperatively	measured from the recovery area until postoperative day 3	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of postoperative rescue analgesia	measured from the recovery area until discharge	7 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
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.	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

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University
• Investigators: Principal Investigator: Guoxin Li, M.D.,Ph.D., Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2023
• Primary Completion (Estimated): October 30, 2023
• Study Completion (Estimated): January 30, 2024

Study Registration Dates

• First Submitted: August 16, 2023
• First Submitted That Met QC Criteria: September 5, 2023
• First Posted (Actual): September 6, 2023

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: NFEC-2023-327

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No