Clinical trial NCT06024200: Transcutaneous Electrical Acupoint Stimulation for Opioid Consumption After Gastrointestinal Laparoscopic Surgery
Official title: Effect of Whole-process Transcutaneous Electrical Acupoint Stimulation on Opioid Consumption After Gastrointestinal Laparoscopic Surgery: a Prospective, Randomised, Blinded, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transcutaneous Electrical Acupoint Stimulation
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 The pump was withdrawn 72h after surgery.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.

Eligibility criteria: 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.

Primary outcomes:
measure: The total sufentanil consumption postoperatively
timeFrame: 3 days
Secondary outcomes:
measure: The number of postoperative rescue analgesia
timeFrame: 7 days
measure: Pain scores (VAS)
timeFrame: 4 days
measure: Pain Catastrophizing
timeFrame: 5 days
measure: Quality of recovery
timeFrame: 5 days
measure: The variation of C-reactive protein（CRP）
timeFrame: 3 days
measure: Procalcitonin（PCT）
timeFrame: 3 days
measure: The variation of white blood cell count （WBC）
timeFrame: 3 days
measure: Neutrophil ratio（NEUT）
timeFrame: 3 days
measure: Time to first ambulation
timeFrame: up to 7 days
measure: Time to first flatus
timeFrame: up to 7 days
measure: Time to first defecation
timeFrame: 7 days
measure: Time to first feed
timeFrame: up to 7 days
measure: The incidence rate of adverse reaction
timeFrame: 7 days
measure: Satisfaction score with pain management
timeFrame: 7 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Guoxin Li, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: