Efficacy of TEAS on Postoperative Pain and Recovery in Patients Undergoing Pancreatectomy
NCT Number: NCT06541561
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pancreatic Cancer
Interventions: DEVICE: transcutaneous electrical acupoint stimulation|DEVICE: sham transcutaneous electrical acupoint stimulation
Sponsor: West China Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 132
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-02
Completion Date: 2026-09-30

Summary:
The purpose of this study is to access the effect of transcutaneous electrical acupoint stimulation on postoperative pain in patients undergoing pancreatectomy

Primary Outcome Measures: Pain scores of pain during movement (i.e. cough or take three deep breaths) at postoperative 24 hours, 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., Up to 24 hours postoperatively
Secondary Outcome Measures: Pain scores of pain during movement (i.e. cough or take three deep breaths) at postoperative 48 and 72 hours., 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., Up to 3 days postoperatively|Pain scores of pain at rest at 24, 48 and 72 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., Up to 3 days postoperatively|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., 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., Up to 3 days postoperatively|The incidence of moderate to severe pain (NRS ≥ 4) at rest at 24,48 and 72 hours after surgery., 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., Up to 3 days postoperatively|The cumulative morphine consumption at 24, 48, and 72 hours postoperatively., Postoperative opioid use is reported as morphine milligram equivalents, calculated using the Practical Pain Management calculator, Up to 72 hours postoperatively|The incidence of postoperative nausea and vomiting during the first 24,48,72 hours., We considered it PONV if patients felt any nausea or had any vomiting., Up to 72 hours postoperatively|The incidence of a composite of postoperative pulmonary complications during hospitalization., 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., Up to 7 days postoperatively|Quality of Recovery Scale Score at 24, 48, and 72 hours after surgery., 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)., Up to 3 days postoperatively|Time of Bowel function recovery, Defined as the time to first defecation or time to first flatus., Up to 3 days postoperatively|Length of hospital stay, Determined by the number of days from admittance to discharge, From admittance to discharge|The postoperative sleep quality score, 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, Up to 3 days postoperatively|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, 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, Up to 5 days postoperatively]