Transcutaneous Electrical Acupoint Stimulation for Opioid Consumption After Gastrointestinal Laparoscopic Surgery

Transcutaneous Electrical Acupoint Stimulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06024200
• Other study ID #: NFEC-2023-327
• Status: Recruiting
• Phase: N/A
• Start date: June 2, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: September 2023
• Source: Nanfang Hospital, Southern Medical University
• Contact: Guoxin Li, M.D.,Ph.D.
• Phone: +86 13802771450
• Email: gzliguoxin[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 The pump was withdrawn 72h after surgery.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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: January 30, 2024
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Transcutaneous Electrical Acupoint Stimulation

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The total sufentanil consumption postoperatively	measured from the recovery area until postoperative day 3	3 days
Secondary	The number of postoperative rescue analgesia	measured from the recovery area until discharge	7 days
Secondary	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
Secondary	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
Secondary	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
Secondary	The variation of C-reactive protein(CRP)	the values of C-reactive protein from peripheral blood	3 days
Secondary	Procalcitonin(PCT)	the values of procalcitonin from peripheral blood	3 days
Secondary	The variation of white blood cell count (WBC)	the values of white blood cell count from peripheral blood	3 days
Secondary	Neutrophil ratio(NEUT)	neutrophil ratio from peripheral blood	3 days
Secondary	Time to first ambulation	time to first ambulation in hours is used	up to 7 days
Secondary	Time to first flatus	time to first flatus in hours is used	up to 7 days
Secondary	Time to first defecation	time to first defecation in hours is used	7 days
Secondary	Time to first feed	time to first feed in hours is used	up to 7 days
Secondary	The incidence rate of adverse reaction	adverse reaction includes PONV?abdominal distension? diarrhea?difficult defecation ect.	7 days
Secondary	Satisfaction score with pain management	measured by 5-point Likert scale, "1" represents very dissatisfied while "5" represents very satisfied	7 days