Efficacy of Transcutaneous Electrical Acupoint Stimulation on Postoperative Pain and Recovery in Patients Undergoing Pancreatectomy: a Prospective, Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pancreatic Cancer
- Sponsor
- West China Hospital
- Enrollment
- 132
- Primary Endpoint
- highest NRS pain score for movement-evoked pain (defined as deep breathing or forced coughing three times) during 72 hours postoperatively.
- Status
- Not Yet Recruiting
- Last Updated
- 9 months ago
Overview
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), Zusanli (ST 36), Hegu (L14) and Waiguan (SJ5) acupoints. The treatment will consist of two phases: a 30-minute stimulation administered 30 minutes before anesthesia induction, and a 30-minute stimulation session once daily on postoperative days 1, 2, and 3. 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.
Investigators
Chunling Jiang
Professor
West China Hospital
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；
Outcomes
Primary Outcomes
highest NRS pain score for movement-evoked pain (defined as deep breathing or forced coughing three times) during 72 hours postoperatively.
Time Frame: Up to 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, and 10 points representing the strongest pain.
Secondary Outcomes
- the highest NRS pain score at rest during 72 h postoperatively(Up to 72 hours postoperatively)
- The cumulative morphine consumption at 24, 48, and 72 hours postoperatively.(Up to 72 hours postoperatively)
- The incidence of postoperative nausea and vomiting during the first 24,48,72 hours.(Up to 72 hours postoperatively)
- The incidence of a composite of postoperative pulmonary complications during hospitalization.(Up to 7 days postoperatively)
- Quality of Recovery Scale Score at 24, 48, and 72 hours after surgery.(Up to 3 days postoperatively)
- The postoperative sleep quality score(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(Up to 5 days postoperatively])