Study protocol for a randomised, patient- and observer-blinded evaluation of P6 acustimulation for the prevention of nausea and vomiting in the postoperative period in patients receiving routine pharmacological prophylaxis (P6NV-Trial)

Abstract

Abstract Background The efficacy of pericardium 6 (P6) acupoint stimulation to reduce the incidence of postoperative nausea and vomiting (PONV) has been proven in several randomised controlled clinical trials. However, little is known about the effectiveness in daily practice and its use in combination with traditional pharmacologic approaches. Methods The primary objective of the P6NV study is to determine whether intraoperative acustimulation (acupuncture or acupressure) at the point P6 provides additional benefit when applied along with customary prophylactic intravenous antiemetics administered according to the local standard operating procedures (SOP). The primary endpoint is the incidence and severity of PONV within the first 24 h postoperatively reported with a validated postoperative nausea and vomiting intensity scale. The patient-reported outcome of perioperative quality of life (using the PPP33-questionnaire) and the detection of antiemetic-related side effects as well as the severity of PONV (via a standardised questionnaire) are secondary study objectives. P6NV is a national, multicentre, randomised, prospective, patient- and examiner-blinded interventional study and will be performed on 3500 adult patients with ASA classification I–III undergoing elective surgery under general anaesthesia and hospitalised for at least 24 h. Participating anaesthesiologists commit themselves to administer customised conventional antiemetic prophylaxis according to the local SOP by signing a statement before randomisation. The intervention group receives bilateral acupuncture or acupressure at P6. The control group receives no intervention. Before extubation, acustimulation is removed. Discussion Since P6 acustimulation is performed by a wide range of anaesthesiologists receiving written and verbal information on acustimulation beforehand, this trial will provide information on the effectiveness of an ad hoc implementation of P6 stimulation techniques in anaesthesia departments using traditional pharmacologic PONV prophylaxis. Trial registration DRKS DRKS00015272. Registered on August 15, 2018.