Clinical trial NCT06541561: Efficacy of TEAS on Postoperative Pain and Recovery in Patients Undergoing Pancreatectomy
Official title: Efficacy of Transcutaneous Electrical Acupoint Stimulation on Postoperative Pain and Recovery in Patients Undergoing Pancreatectomy: a Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief 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.

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；

Primary outcomes:
measure: Pain scores of pain during movement (i.e. cough or take three deep breaths) at postoperative 24 hours
timeFrame: Up to 24 hours postoperatively
Secondary outcomes:
measure: Pain scores of pain during movement (i.e. cough or take three deep breaths) at postoperative 48 and 72 hours.
timeFrame: Up to 3 days postoperatively
measure: Pain scores of pain at rest at 24, 48 and 72 hours postoperatively.
timeFrame: Up to 3 days postoperatively
measure: The incidence of moderate to severe pain (NRS ≥ 4) during movement (i.e. cough or take three deep breaths) at 24,48 and 72 hours after surgery.
timeFrame: Up to 3 days postoperatively
measure: The incidence of moderate to severe pain (NRS ≥ 4) at rest at 24,48 and 72 hours after surgery.
timeFrame: Up to 3 days postoperatively
measure: The cumulative morphine consumption at 24, 48, and 72 hours postoperatively.
timeFrame: Up to 72 hours postoperatively
measure: The incidence of postoperative nausea and vomiting during the first 24,48,72 hours.
timeFrame: Up to 72 hours postoperatively
measure: The incidence of a composite of postoperative pulmonary complications during hospitalization.
timeFrame: Up to 7 days postoperatively
measure: Quality of Recovery Scale Score at 24, 48, and 72 hours after surgery.
timeFrame: Up to 3 days postoperatively
measure: Time of Bowel function recovery
timeFrame: Up to 3 days postoperatively
measure: Length of hospital stay
timeFrame: From admittance to discharge
measure: The postoperative sleep quality score
timeFrame: Up to 3 days postoperatively
measure: The plasma levels of C-reactive protein (CRP), procalcitonin (PCT), beta-endorphin, serotonin (5-HT), interleukin-2 (IL-2), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α) on the 1st, 3rd, and 5th postoperative days
timeFrame: Up to 5 days postoperatively]
Other outcomes:
Locations:
Study officials:
affiliation: West China Hospital
name: Luo Fengming, PhD
role: PRINCIPAL_INVESTIGATOR
References: