Back to resultsTranscutaneous Electrical Acupoint Stimulation for Opioid Consumption After Gastrointestinal Laparoscopic Surgery
Primary Purpose
Transcutaneous Electrical Acupoint Stimulation
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
transcutaneous electrical acupoint stimulation
transcutaneous electrical acupoint stimulation sham stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Transcutaneous Electrical Acupoint Stimulation
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.
Sites / Locations
- Nanfang Hospital, Southern Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
whole-process transcutaneous electrical acupoint stimulation
whole-process transcutaneous electrical acupoint stimulation(sham stimulation)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
The total sufentanil consumption postoperatively
measured from the recovery area until postoperative day 3
Secondary Outcome Measures
The number of postoperative rescue analgesia
measured from the recovery area until discharge
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.
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.
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.
The variation of C-reactive protein（CRP）
the values of C-reactive protein from peripheral blood
Procalcitonin（PCT）
the values of procalcitonin from peripheral blood
The variation of white blood cell count （WBC）
the values of white blood cell count from peripheral blood
Neutrophil ratio（NEUT）
neutrophil ratio from peripheral blood
Time to first ambulation
time to first ambulation in hours is used
Time to first flatus
time to first flatus in hours is used
Time to first defecation
time to first defecation in hours is used
Time to first feed
time to first feed in hours is used
The incidence rate of adverse reaction
adverse reaction includes PONV、abdominal distension、 diarrhea、difficult defecation ect.
Satisfaction score with pain management
measured by 5-point Likert scale, "1" represents very dissatisfied while "5" represents very satisfied
Full Information
NCT ID
NCT06024200
First Posted
August 16, 2023
Last Updated
September 6, 2023
Sponsor
Nanfang Hospital, Southern Medical University
1. Study Identification
Unique Protocol Identification Number
NCT06024200
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2, 2023 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang Hospital, Southern Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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：
Before the end of the operation, the surgical incision was infiltrated with 0.5% ropivacaine 10 mL locally.
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.
Flurbiprofen: 50mg per dose intravenously twice a day for postoperative three days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transcutaneous Electrical Acupoint Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
whole-process transcutaneous electrical acupoint stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
whole-process transcutaneous electrical acupoint stimulation(sham stimulation)
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
transcutaneous electrical acupoint stimulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
transcutaneous electrical acupoint stimulation sham stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
The total sufentanil consumption postoperatively
Description
measured from the recovery area until postoperative day 3
Time Frame
3 days
Secondary Outcome Measure Information:
Title
The number of postoperative rescue analgesia
Description
measured from the recovery area until discharge
Time Frame
7 days
Title
Pain scores (VAS)
Description
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.
Time Frame
4 days
Title
Pain Catastrophizing
Description
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.
Time Frame
5 days
Title
Quality of recovery
Description
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.
Time Frame
5 days
Title
The variation of C-reactive protein（CRP）
Description
the values of C-reactive protein from peripheral blood
Time Frame
3 days
Title
Procalcitonin（PCT）
Description
the values of procalcitonin from peripheral blood
Time Frame
3 days
Title
The variation of white blood cell count （WBC）
Description
the values of white blood cell count from peripheral blood
Time Frame
3 days
Title
Neutrophil ratio（NEUT）
Description
neutrophil ratio from peripheral blood
Time Frame
3 days
Title
Time to first ambulation
Description
time to first ambulation in hours is used
Time Frame
up to 7 days
Title
Time to first flatus
Description
time to first flatus in hours is used
Time Frame
up to 7 days
Title
Time to first defecation
Description
time to first defecation in hours is used
Time Frame
7 days
Title
Time to first feed
Description
time to first feed in hours is used
Time Frame
up to 7 days
Title
The incidence rate of adverse reaction
Description
adverse reaction includes PONV、abdominal distension、 diarrhea、difficult defecation ect.
Time Frame
7 days
Title
Satisfaction score with pain management
Description
measured by 5-point Likert scale, "1" represents very dissatisfied while "5" represents very satisfied
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guoxin Li, M.D.,Ph.D.
Phone
+86 13802771450
Email
gzliguoxin@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fang Qin, MS.N.
Phone
+86 15018410013
Email
qf_smu@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guoxin Li, M.D.,Ph.D.
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510-515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guoxin Li, M.D.,Ph.D.
Phone
+8613802771450
Email
gzliguoxin@163.com
12. IPD Sharing Statement
Learn more about this trial
Transcutaneous Electrical Acupoint Stimulation for Opioid Consumption After Gastrointestinal Laparoscopic Surgery
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