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
1 other identifier
interventional
128
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 2, 2023
CompletedFirst Submitted
Initial submission to the registry
August 16, 2023
CompletedFirst Posted
Study publicly available on registry
September 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2024
CompletedSeptember 11, 2023
September 1, 2023
5 months
August 16, 2023
September 6, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
The total sufentanil consumption postoperatively
measured from the recovery area until postoperative day 3
3 days
Secondary Outcomes (14)
The number of postoperative rescue analgesia
7 days
Pain scores (VAS)
4 days
Pain Catastrophizing
5 days
Quality of recovery
5 days
The variation of C-reactive protein（CRP）
3 days
- +9 more secondary outcomes
Study Arms (2)
whole-process transcutaneous electrical acupoint stimulation
EXPERIMENTALElectrical 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.
whole-process transcutaneous electrical acupoint stimulation(sham stimulation)
SHAM COMPARATORPatients 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510-515, China
Study Officials
- PRINCIPAL INVESTIGATOR
Guoxin Li, M.D.,Ph.D.
Nanfang Hospital, Southern Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2023
First Posted
September 6, 2023
Study Start
June 2, 2023
Primary Completion
October 30, 2023
Study Completion
January 30, 2024
Last Updated
September 11, 2023
Record last verified: 2023-09