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Completed

NCT Number: NCT04799587

Accupressure of P6 to Reduce Nausea During Cesarean Section

The purpose of this study is to evaluate if the addition of P6 pressure point stimulation as opposed to sham-point stimulation will decrease intraoperative and postoperative nausea and vomiting (IONV and PONV) for patients undergoing non-emergent cesarean delivery. We hypothesize that the addition of stimulation of the P6 pressure point to our institutional current standard of care (phenylephrine infusion, intravenous fluid bolus, and as needed intraoperative ondansetron) will decrease the occurrence of intraoperative emesis.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

About this study

After obtaining written informed consent from the subject. They were then randomized to either the P6 acupressure or a sham acupressure group. Envelopes containing group assignment information were prepared prior to the start of the study by research personnel not involved in this study. Randomization occurred by selecting a sealed envelope that contained the group assignment, two acupressure 0.09-inch by 0.2-inch diameter devices, and a diagram of where to place the device from a pool of 200 envelopes. The acupressure devices used in this study are also used in clinical practice by Northwestern Medicine Osher Center for Integrative Medicine (Plaster - Accu Band 800 NP Magnets, Japan). Prior to the commencement of the study, the Center for Integrative Medicine acupuncturists educated study personnel on the placement of the devices and the proper patient-initiated stimulation method when the subject began to perceive nausea. Device placement took place in the preoperative room, prior to walking to the operating room for the surgical procedure, by research personnel not involved in the clinical care of study subjects. In the P6 acupressure group, the devices were placed two inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus bilaterally. The small protrusion on the device was placed on the skin and held in place using an adhesive sticker at the stimulation point. In the sham acupressure group, the devices were placed distal and lateral to the P6 acupoint site, like in prior studies comparing the effectiveness of P6 acupressure to sham. This method of sham acupoint placement when compared to P6 acupoint placement has shown superiority of the P6 acupoint placement in 70% of studies that have used this point for sham.15 The devices are designed to maintain pressure at the point of placement without additional force applied. Research personnel also instructed subjects to apply additional pressure at the acupressure site for a period of 30 s-2 min if they perceived nausea. Subjects were then taken to the operating room where they received neuraxial anesthesia consisting of either a spinal anesthetic dosed with hyperbaric bupivacaine 12 mg plus fentanyl 15 mcg and morphine 150 mcg, or a combined spinal epidural with the same intrathecal dosing per institutional standard practice. Co-loading with a crystalloid solution occurred upon the start of the neuraxial procedure, and a phenylephrine infusion was started immediately after the cerebrospinal fluid was obtained. Maternal hypotension was defined as a systolic blood pressure less than 100 mmHg, mean arterial pressure less than 65 mmHg, or mean arterial pressure less than 20% of the baseline mean arterial pressure. The baseline blood pressure was considered the average value of three blood pressure readings obtained by the nursing staff in the preoperative area. Subjects were asked to report any nausea, retching, or vomiting to the anesthesia care team. In addition, the anesthesia provider asked the study subject about nausea or vomiting at intervals corresponding to events that are associated with a greater prevalence of nausea and vomiting (e.g. neuraxial dose administration, uterine exteriorization, and following uterotonic administration) as well as when the anesthesia provider observed the subject massaging the acupressure point. After the first complaint of nausea, subjects were encouraged to apply additional pressure to the devices, an intravenous (IV) fluid bolus was administered, and phenylephrine or ephedrine was administered by IV bolus and/or by increasing the infusion rate of phenylephrine if hypotension was present. At the second complaint of nausea or emesis, study subjects were again encouraged to apply additional pressure on the devices. Following delivery of the fetus, ondansetron 8 mg IV and dexamethasone 8 mg IV were administered. If intraoperative nausea and/or vomiting continued, study subjects were again encouraged to apply additional acupressure. If this was ineffective, prochlorperazine, promethazine, metoclopramide, fentanyl, or propofol were administered at the anesthesiologist's discretion. If these antiemetic agents were ineffective, the anesthesiologist could provide additional medications.

Routine postoperative orders, including antiemetic medications as needed, were placed by the anesthesiology team for postpartum use per our institution's current standard of care. Postoperative medications were administered and documented by the nursing staff. Study subjects were also encouraged to use additional acupressure as needed throughout their postoperative course, for up to 48 h or until discharge, whichever came first. A study team member replaced devices that were lost or removed the device if the study subject requested it. Prior to discharge, subjects were visited by study personnel and asked to complete a survey asking them to describe the incidence, duration, and severity of nausea and vomiting, interference of nausea/vomiting with the ability to care for themselves, and their rating and satisfaction of the acupressure therapy.

Baseline data collected were age, weight, height, body mass index, American Society of Anesthesiologists physical status classification, race, ethnicity, history of nausea and vomiting, parity, and the number of prior cesarean delivery. Intraoperative data included the type of neuraxial anesthesia, initial blood pressure in the operating room, the lowest recorded blood pressure intraoperatively, total vasopressor use (expressed as phenylephrine equivalents),18 the number of hypotensive episodes, crystalloid administered, and duration of anesthesia. Intraoperative nausea and vomiting outcomes included the number of subjects with nausea and/or vomiting, the number of emesis episodes, and the need for rescue antiemetic administration in the operating room. Post delivery emesis and antiemetic treatments were recorded in the post anesthesia care unit (PACU) in 0-24 h and 24-48 h periods. Study subject questionnaires were collected at the end of the study period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥18 years of age
  • English-speaking
  • Pregnant patients presenting for scheduled cesarean delivery of a full-term fetus (>37 weeks' gestation)
  • Patients scheduled as ERAC
  • Parturients undergoing spinal anesthesia

Exclusion criteria

  • Patients requiring emergent delivery,
  • Fetal demise
  • Patients with adhesive allergy/sensitivity
  • Patients with allergy/sensitivity to nickel,
  • Patients with inability to consent,
  • Patients with known abnormal placentation
  • Patients with pacemakers/defibrillators
  • Patients with positive COVID-19 tests

Treatment and study plan

Magnet at P6

Other

Magnet applied at P6 and attached with adhesive tape. The P6 pressure point is 2 inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus.

Magnet applied to arm not at P6 pressure point.

Other

Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.

Primary outcomes

  1. Presence of Intraoperative Vomiting

    Time frame: Intraoperative Period

    Presence of intraoperative vomiting during scheduled cesarean delivery (intraoperative period).

  2. Presence of Intraoperative Nausea

    Time frame: Intraoperative period

    Presence of intraoperative nausea during scheduled cesarean delivery (intraoperative period).

Secondary outcomes

  1. Number of Emesis Episodes in the Intraoperative Period Period

    Time frame: Intraoperative period

    The number of emesis episodes during the cesarean section intraoperative period.

  2. Number of Rescue Antiemetic Doses Administered for the Treatment of Intraoperative Nausea and Vomiting

    Time frame: Intraoperative period

    Reported total number (count) of rescue antiemetics administered per group during the intraoperative period. Rescue antiemetics are defined as the use of intravenous administered prochlorperazine, promethazine, or metoclopramide.

Other outcomes

  1. The Number of Emesis From Post Anesthesia Care Unit to Discharge.

    Time frame: 96 hours

    Reported total number (count) of emesis episodes per group from admission to the post anesthesia care unit after the operative procedure to discharge from the hospital.

  2. Antiemetic Medication Administered From the PACU Through Discharge

    Time frame: 96 hours

    The number(count) of antiemetic medication administered per group in the post anesthesia care unit through discharge from the hospital

  3. Patient Questionnaire: Have You Experienced Dry Retching or Vomiting

    Time frame: 96 Hours

    Patient recovery questionnaire administered prior to discharge from the hospital. Have you experienced dry retching or vomiting?

  4. Patient Questionnaire: Number of Times Vomited

    Time frame: 96 Hours

    Patient recovery questionnaire administered prior to discharge from the hospital. (of those who indicated vomiting) How many times did you vomit.

  5. Number of Participants With Nausea

    Time frame: 96 Hours

    Patient recovery questionnaire administered prior to discharge from the hospital. Have you experienced nausea?

  6. Patient Questionnaire: Describe the Pattern of Your Nausea?

    Time frame: 96 Hours

    Patient recovery questionnaire administered prior to discharge from the hospital. (of those who had nausea)Describe the pattern of your nausea (2 choices).

  7. Patient Questionnaire: Did the Nausea Interfere With You Ability to Care for Yourself?

    Time frame: 96 Hours

    Patient recovery questionnaire administered prior to discharge from the hospital. (of those who had nausea) How did the nausea interfere with your ability to care for yourself.

  8. Patient Questionnaire: Duration of Nausea.

    Time frame: 96 Hours

    Patient recovery questionnaire administered prior to discharge from the hospital. (of those who had nausea) How many hours did the nausea last.

  9. Patient Questionnaire: Severity of Nausea.

    Time frame: 96 Hours

    Patient recovery questionnaire administered prior to discharge from the hospital. (of those who had nausea).Severity of nausea based on a 0 (none) -100 (very severe).

  10. Patient Questionnaire: Do You Think the Magnet Improves Nausea?

    Time frame: 96 Hours

    Patient recovery questionnaire administered prior to discharge from the hospital. Does the magnet improve nausea response yes or no.

  11. Patient Questionnaire: Do You Think the Magnet Improves Vomiting?

    Time frame: 96 Hours

    Patient recovery questionnaire administered prior to discharge from the hospital. Does the magnet improve vomiting response yes or no.

  12. Patient Questionnaire: Are You Satisfied With Acupressure?

    Time frame: 96 Hours

    Patient recovery questionnaire administered prior to discharge from the hospital. Are you satisfied with acupressure response yes or no.

  13. Intraoperative Lowest BP (mmHg)

    Time frame: Intraoperative period

    Lowest systolic and diastolic blood pressure during the intraoperative period.

  14. Intraoperative Total Vasopressor (VPE) [1]

    Time frame: Intraoperative period

    Measure Description: Total vasopressor units expressed as phenylephrine units using an 80:1 ratio for ephedrine in micrograms.

  15. Intraoperative Hypotension Episodes (n)

    Time frame: Intraoperative

    Number of hypotension episodes experienced during the intraoperative period.

  16. Intraoperative Crystalloid Co-load (mL)

    Time frame: Intraoperative period

    Amount of crystalloid fluids given as a co-load in milliliters during the intraoperative period.

  17. Intraoperative Fluids Administered (mL)

    Time frame: Intraoperative

    Total number of milliliters of fluids administered during the intraoperative period.

  18. Duration of Intraoperative Anesthesia (Min)

    Time frame: Intraoperative period

    Duration of administration of intraoperative anesthesia in minutes.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

The Use of P6 Acupressure for the Reduction of Intraoperative and Postoperative Nausea and Vomiting in Women Undergoing Cesarean Delivery: a Randomized Trial

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 16, 2021
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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