Efficacy of TEAS on Postoperative Pain and Recovery in Patients Undergoing Pancreatectomy
- Conditions
- Pancreatic Cancer
- Interventions
- Device: sham transcutaneous electrical acupoint stimulationDevice: transcutaneous electrical acupoint stimulation
- Registration Number
- NCT06541561
- Lead Sponsor
- West China Hospital
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 132
Age 18-80 years old; ASA physical status class I - III; Patients scheduled for pancreatectomy.
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；
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description sham group sham transcutaneous electrical acupoint stimulation Patients in the sham group will receive electrode attachment but without stimulation. TEAS group transcutaneous electrical acupoint stimulation 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.
- Primary Outcome Measures
Name Time Method Pain scores of pain during movement (i.e. cough or take three deep breaths) at postoperative 24 hours Up to 24 hours postoperatively The pain is evaluated using numerical rating scale(NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, 1-3 points representing mild pain, 4-6 points representing moderate pain, 7-9 points representing severe pain and 10 points representing the strongest pain.
- Secondary Outcome Measures
Name Time Method Pain scores of pain during movement (i.e. cough or take three deep breaths) at postoperative 48 and 72 hours. Up to 3 days postoperatively The pain is evaluated using numerical rating scale(NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, 1-3 points representing mild pain, 4-6 points representing moderate pain, 7-9 points representing severe pain and 10 points representing the strongest pain.
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. Up to 3 days postoperatively The pain is evaluated using numerical rating scale(NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, 1-3 points representing mild pain, 4-6 points representing moderate pain, 7-9 points representing severe pain and 10 points representing the strongest pain.
The incidence of moderate to severe pain (NRS ≥ 4) at rest at 24,48 and 72 hours after surgery. Up to 3 days postoperatively The pain is evaluated using numerical rating scale(NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, 1-3 points representing mild pain, 4-6 points representing moderate pain, 7-9 points representing severe pain and 10 points representing the strongest pain.
Length of hospital stay From admittance to discharge Determined by the number of days from admittance to discharge
The postoperative sleep quality score Up to 3 days postoperatively Postoperative sleep quality was evaluated using the Athens Insomnia Scale (AIS). The AIS consists of 8 items: waking up at night, sleep induction, final awakening, total sleep duration, sleep quality, well-being, functional ability, and daytime sleepiness. The AIS score ranges from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia
Pain scores of pain at rest at 24, 48 and 72 hours postoperatively. Up to 3 days postoperatively The pain is evaluated using numerical rating scale(NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, 1-3 points representing mild pain, 4-6 points representing moderate pain, 7-9 points representing severe pain and 10 points representing the strongest pain.
Quality of Recovery Scale Score at 24, 48, and 72 hours after surgery. Up to 3 days postoperatively The global QoR-15 score ranges from 0 to 150 and is categorized as five quality of recovery dimensions, including physical comfort (5 items), emotional state (4 items), psychological support (2 items), physical independence (2 items), and pain (2 items). Each piece is graded using an 11-point Likert scale. The QoR is classified according to the QoR-15 score as excellent (QoR-15 \> 135), good (122 ≤ QoR-15 ≤ 135), moderate (90 ≤ QoR-15 ≤ 121) and poor (QoR-15 \< 90).
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 Up to 5 days postoperatively] Peripheral blood 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) are measured at the 1st, 3rd, and 5th postoperative
The cumulative morphine consumption at 24, 48, and 72 hours postoperatively. Up to 72 hours postoperatively Postoperative opioid use is reported as morphine milligram equivalents, calculated using the Practical Pain Management calculator
The incidence of postoperative nausea and vomiting during the first 24,48,72 hours. Up to 72 hours postoperatively We considered it PONV if patients felt any nausea or had any vomiting.
Time of Bowel function recovery Up to 3 days postoperatively Defined as the time to first defecation or time to first flatus.
The incidence of a composite of postoperative pulmonary complications during hospitalization. Up to 7 days postoperatively Defined as positive if any component developed before discharge after surgery; These complications included respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, or aspiration pneumonitis loading dose, during hospitalization after surgery.