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Trial Title:
Efficacy of TEAS on Postoperative Pain and Recovery in Patients Undergoing Pancreatectomy
NCT ID:
NCT06541561
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pain, Postoperative
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Patients who meet the enrollment criteria will be randomized 1:1 to either the
transcutaneous electrical acupoint stimulation (TEAS) or the sham groups using a
computer-generated random number table. After the randomization, use the opaque envelope,
hide each group envelope into an opaque envelope, the envelope outside the code, will be
sealed to the researcher, when the study, if the inclusion criteria, then open the
corresponding numbered envelope, and intervene according to the group scheme in the
envelope.
Primary purpose:
Treatment
Masking:
Double (Participant, Outcomes Assessor)
Masking description:
Blinding of participants will be maintained throughout the observation period. The sham
group will receive electrode attachment but without stimulation, Throughout the study,
for adequate blinding, an opaque tape will be applied to the patient's skin above the
electrodes, and the patient's target acupoints will be wrapped in a blanket. All patients
will be informed that they might or might not feel a tingling sensation around the
acupoints when the TEAS device is working. The patients should not be unblinded until the
statistical analysis of the study data is completed.
Intervention:
Intervention type:
Device
Intervention name:
transcutaneous electrical acupoint stimulation
Description:
Patients who meet the enrollment criteria will be randomized 1:1 to either the
transcutaneous electrical acupoint stimulation (TEAS) or the sham groups. In the TEAS
group, the acupoints are bilateral neiguan (PC6) and Zusanli(ST 36) acupoints.
Patients will receive 30min TEAS before anesthesia until be discharged from the post
anaesthesia care unit (PACU). The same treatment for 30 min will be performed on the 1st,
2nd and 3rd days after surgery. The stimulation intensity will be adjusted in accordance
with the maximal level tolerated by each patient.
Arm group label:
TEAS group
Intervention type:
Device
Intervention name:
sham transcutaneous electrical acupoint stimulation
Description:
Patients in the sham group will receive electrode attachment but without stimulation.
Arm group label:
sham group
Summary:
The purpose of this study is to access the effect of transcutaneous electrical acupoint
stimulation on postoperative pain in patients undergoing pancreatectomy
Detailed description:
Patients who meet the enrollment criteria will be randomized 1:1 to either the
transcutaneous electrical acupoint stimulation (TEAS) or the sham groups. In the TEAS
group, the acupoints are bilateral neiguan (PC6) and Zusanli (ST 36) acupoints. Patients
will receive TEAS 30min before anesthesia until being discharged from the postanaesthesia
care unit (PACU). The same treatment for 30 min will be performed on the 1st, 2nd and 3rd
days after surgery. The stimulation intensity will be adjusted in accordance with the
maximal level tolerated by each patient.
Patients in the sham group will receive electrode attachment but without stimulation.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Age 18-80 years old; ASA physical status class I - III; Patients scheduled for
pancreatectomy.
Exclusion Criteria:
Have a history of epilepsy; Rash or local infection over the acupoint stimulation skin
area; Pregnancy or breastfeeding; Mental retardation, psychiatric, or neurological
disease; Inability to comprehend the numeric rating scale (NRS); Implantation of a
cardiac pacemaker, cardioverter, or defibrillator; Chronic opioid use; Metastases in
other organs; Have a history of Transcutaneous Electrical Acupuncture Stimulation (TEAS)
or electroacupuncture treatment in the past or recently；
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
September 2, 2024
Completion date:
September 30, 2026
Lead sponsor:
Agency:
West China Hospital
Agency class:
Other
Source:
West China Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06541561
