Nausea, Satisfaction, Vomiting
Conditions
Brief summary
The purpose of this study is to compare the effectiveness of acupressure point P6 stimulation versus intravenous ondansetron plus metoclopramide versus no antiemetic prophylaxis during elective cesarean section under regional anesthesia.
Detailed description
The design of the study consists of the randomization of subjects undergoing cesarean section with regional anesthesia in one of three groups. The study is not blinded; as the participants will know which method they are being treated with because of the difference in site and nature of the acupuncture point P6 stimulation. The randomization of patients will be done by a computer to avoid bias before the informed consent form (ICF) is signed by the patients. The computer will generate three sets of random numbers for the three groups. Once the consent form is signed, the investigator will allocate the patients serially to the groups having those numbers . The randomization will be created before the study begins and will assign 180 subjects into one of the three groups to receive the treatment as follows: Group I (n=60): Will be the control group patients and will not be given traditional medical therapy nor will receive acupuncture point P6 stimulation prior to administration of the standardized epidural anesthesia, as outlined below. Group II (n=60): Will receive traditional medical management, consisting of 10 mg metoclopramide IV and 8 mg of ondansetron IV immediately prior to administration of the standardized regional anesthesia, as outlined below. Group III (n=60): Will receive acupuncture point P6 stimulation. This is a stimulation of the chi channel at the master of the heart (MH8 position) at the small depression of the volar surface of the distal right forearm just above the crest of the wrist. The device will be put on the patients in the operating room prior to administration of the regional anesthesia and will be removed after the cesarean section is complete. The device will be removed from the patient in the operating room, before the patient is transported to the recovery room. Patients will receive continuous stimulation at a level that is comfortable for the patient prior to administration of the standardized regional anesthesia, as outlined below. After the subjects have been randomly assigned to one of the three groups, subjects will receive the standardized regional anesthesia consisting of 2 milliliters (10 milligrams) of 0.5% bupivicaine and 20 micrograms of fentanyl and 100 micrograms of epinephrine. Patients will offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea every experienced). An Apfel score, which is used to predict the risk of experiencing post-operative nausea and vomiting (PONV), will also be determined with each subject.
Interventions
DEVICEAcupressure Point P6 stimulator
This device stimulates the chi channel at the master of the heart (MH8 position) at the small depression of the volar surface of the distal right forearm just above the crest of the wrist. The device is placed on patients in the operating room prior to administration of the regional anesthesia and will be removed after the cesarean section is complete. The device is removed from the patient in the operating room, before the patient is transported to the recovery room. Patients receive continuous stimulation at a level that is comfortable for the patient prior to administration of the standardized regional anesthesia.
DRUGMetoclopramide
10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.
DRUGOndansetron
8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Female subjects ages 18 to 45 2. Subjects with American Society of Anesthesiologists (ASA) Class I or II 3. Subjects with elective primary or repeat cesarean delivery 4. Subjects who receive combined spinal epidural anesthesia 5. English and non-English speaking subjects will be included in the study
Exclusion criteria
1. Female subjects \<18 years of age 2. Subjects requiring emergent cesarean delivery 3. History of placenta accrete 4. Multiple gestation pregnancy 5. ASA status III or higher 6. Current history of pregnancy induced hypertension, pre-eclampsia, or eclampsia 7. History of any chronic medication use (other than prenatal vitamins), including inhaler medications 8. Current urinary tract infection, pneumonia, or otitis media
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nausea | During the surgical procedure | The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea at any point during the surgical procedure in each group. |
| Vomiting | During the surgical procedure | The investigators will perform objective assessments of whether or not the patients have vomited during the procedure. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nausea During Stage III (After Replacement of the Uterus and to the Next 15 Minutes) | During the surgical procedure | Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage III. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea. |
| Nausea During Stage IV (the Rest of the Time Until Arrival at PACU) | During the surgical procedure | Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage IV. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea. |
| Vomiting During Stage I (After the Administration of CSE and Until Eversion of the Uterus) | During the surgical procedure | The investigators will perform objective assessments of whether or not the patients have vomited during stage I. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group. |
| Vomiting During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus) | During the surgical procedure | The investigators will perform objective assessments of whether or not the patients have vomited during stage II. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group. |
| Nausea During Stage I (After the Administration of CSE and Until Eversion of the Uterus) | During the surgical procedure | Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage I. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea. |
| Vomiting During Stage IV (the Rest of the Time Until Arrival at PACU) | During the surgical procedure | The investigators will perform objective assessments of whether or not the patients have vomited during stage IV. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group. |
| Satisfaction of Anti-emetic Treatment | During the surgical procedure | Patients are asked their anti-emetic treatment satisfaction (0 = Not Satisfied, 10 = Extremely Satisfied). Data are expressed as number of parturients who gave a score of 8 or higher. |
| Overall Anesthetic Care Satisfaction | During the surgical procedure | Patients are asked their overall anesthetic care satisfaction (0 = Not Satisfied, 10 = Extremely Satisfied). Data are expressed as number of parturients who gave a score of 8 or higher. |
| Vomiting During Stage III (After Replacement of the Uterus and to the Next 15 Minutes) | During the surgical procedure | The investigators will perform objective assessments of whether or not the patients have vomited during stage III. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group. |
| Nausea During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus) | During the surgical procedure | Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage II. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control No anti-emetic medications and no acupuncture point P6 stimulation prior to administration of the standardized regional anesthesia | 60 |
| Metoclopramide, Ondansetron 10 mg Metoclopramide IV and 8 mg of Ondansetron IV immediately prior to administration of the standardized regional anesthesia
Metoclopramide: 10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.
Ondansetron: 8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia. | 60 |
| Acupressure Point P6 Stimulator Acupuncture point P6 stimulation. The device was put on the patients in the operating room prior to administration of the regional anesthesia and was removed after the cesarean section was complete. | 60 |
| Total | 180 |
Baseline characteristics
| Characteristic | Total | Metoclopramide, Ondansetron | Acupressure Point P6 Stimulator | Control |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 180 Participants | 60 Participants | 60 Participants | 60 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — |
| Region of Enrollment United States | 180 participants | 60 participants | 60 participants | 60 participants |
| Sex: Female, Male Female | 180 Participants | 60 Participants | 60 Participants | 60 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 0 / 60 | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 | 0 / 60 |
Outcome results
Primary
Nausea
The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea at any point during the surgical procedure in each group.
Time frame: During the surgical procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Nausea | 44 Participants |
| Metoclopramide, Ondansetron | Nausea | 14 Participants |
| Acupressure Point P6 Stimulator | Nausea | 22 Participants |
p-value: <0.00001Chi-squared
p-value: 0.00005Chi-squared
p-value: 0.1Chi-squared
Primary
Vomiting
The investigators will perform objective assessments of whether or not the patients have vomited during the procedure. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.
Time frame: During the surgical procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Vomiting | 27 Participants |
| Metoclopramide, Ondansetron | Vomiting | 10 Participants |
| Acupressure Point P6 Stimulator | Vomiting | 8 Participants |
p-value: 0.001Chi-squared
p-value: 0.0002Chi-squared
p-value: 0.8Chi-squared
Secondary
Nausea During Stage I (After the Administration of CSE and Until Eversion of the Uterus)
Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage I. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.
Time frame: During the surgical procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Nausea During Stage I (After the Administration of CSE and Until Eversion of the Uterus) | 33 Participants |
| Metoclopramide, Ondansetron | Nausea During Stage I (After the Administration of CSE and Until Eversion of the Uterus) | 7 Participants |
| Acupressure Point P6 Stimulator | Nausea During Stage I (After the Administration of CSE and Until Eversion of the Uterus) | 14 Participants |
p-value: 0.00004Chi-squared
p-value: 0.0004Chi-squared
p-value: 0.09Chi-squared
Secondary
Nausea During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus)
Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage II. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.
Time frame: During the surgical procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Nausea During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus) | 12 Participants |
| Metoclopramide, Ondansetron | Nausea During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus) | 6 Participants |
| Acupressure Point P6 Stimulator | Nausea During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus) | 5 Participants |
p-value: 0.1Chi-squared
p-value: 0.07Chi-squared
p-value: 0.7Chi-squared
Secondary
Nausea During Stage III (After Replacement of the Uterus and to the Next 15 Minutes)
Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage III. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.
Time frame: During the surgical procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Nausea During Stage III (After Replacement of the Uterus and to the Next 15 Minutes) | 16 Participants |
| Metoclopramide, Ondansetron | Nausea During Stage III (After Replacement of the Uterus and to the Next 15 Minutes) | 8 Participants |
| Acupressure Point P6 Stimulator | Nausea During Stage III (After Replacement of the Uterus and to the Next 15 Minutes) | 14 Participants |
p-value: 0.7Chi-squared
p-value: 0.7Chi-squared
p-value: 0.2Chi-squared
Secondary
Nausea During Stage IV (the Rest of the Time Until Arrival at PACU)
Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) during stage IV. The investigators will analyze if there is a statistically significant difference between the number of patients that experience nausea in each group at this point. Patients that report nausea (1 or more on our scale) will be recorded as that they have experienced nausea.
Time frame: During the surgical procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Nausea During Stage IV (the Rest of the Time Until Arrival at PACU) | 3 Participants |
| Metoclopramide, Ondansetron | Nausea During Stage IV (the Rest of the Time Until Arrival at PACU) | 4 Participants |
| Acupressure Point P6 Stimulator | Nausea During Stage IV (the Rest of the Time Until Arrival at PACU) | 0 Participants |
p-value: 1Chi-squared
p-value: 0.2Chi-squared
p-value: 0.1Chi-squared
Secondary
Overall Anesthetic Care Satisfaction
Patients are asked their overall anesthetic care satisfaction (0 = Not Satisfied, 10 = Extremely Satisfied). Data are expressed as number of parturients who gave a score of 8 or higher.
Time frame: During the surgical procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Overall Anesthetic Care Satisfaction | 53 Participants |
| Metoclopramide, Ondansetron | Overall Anesthetic Care Satisfaction | 58 Participants |
| Acupressure Point P6 Stimulator | Overall Anesthetic Care Satisfaction | 56 Participants |
p-value: 0.2Fisher Exact
p-value: 0.5Fisher Exact
p-value: 0.7Fisher Exact
Secondary
Satisfaction of Anti-emetic Treatment
Patients are asked their anti-emetic treatment satisfaction (0 = Not Satisfied, 10 = Extremely Satisfied). Data are expressed as number of parturients who gave a score of 8 or higher.
Time frame: During the surgical procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Satisfaction of Anti-emetic Treatment | 49 Participants |
| Metoclopramide, Ondansetron | Satisfaction of Anti-emetic Treatment | 58 Participants |
| Acupressure Point P6 Stimulator | Satisfaction of Anti-emetic Treatment | 55 Participants |
p-value: 0.02Fisher Exact
p-value: 0.2Fisher Exact
p-value: 0.3Fisher Exact
Secondary
Vomiting During Stage I (After the Administration of CSE and Until Eversion of the Uterus)
The investigators will perform objective assessments of whether or not the patients have vomited during stage I. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.
Time frame: During the surgical procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Vomiting During Stage I (After the Administration of CSE and Until Eversion of the Uterus) | 20 Participants |
| Metoclopramide, Ondansetron | Vomiting During Stage I (After the Administration of CSE and Until Eversion of the Uterus) | 5 Participants |
| Acupressure Point P6 Stimulator | Vomiting During Stage I (After the Administration of CSE and Until Eversion of the Uterus) | 4 Participants |
p-value: 0.001Chi-squared
p-value: 0.0004Chi-squared
p-value: 1Chi-squared
Secondary
Vomiting During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus)
The investigators will perform objective assessments of whether or not the patients have vomited during stage II. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.
Time frame: During the surgical procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Vomiting During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus) | 10 Participants |
| Metoclopramide, Ondansetron | Vomiting During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus) | 1 Participants |
| Acupressure Point P6 Stimulator | Vomiting During Stage II (After Eversion of the Uterus and Until Replacement of the Uterus) | 3 Participants |
p-value: 0.008Chi-squared
p-value: 0.07Chi-squared
p-value: 0.6Chi-squared
Secondary
Vomiting During Stage III (After Replacement of the Uterus and to the Next 15 Minutes)
The investigators will perform objective assessments of whether or not the patients have vomited during stage III. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.
Time frame: During the surgical procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Vomiting During Stage III (After Replacement of the Uterus and to the Next 15 Minutes) | 9 Participants |
| Metoclopramide, Ondansetron | Vomiting During Stage III (After Replacement of the Uterus and to the Next 15 Minutes) | 4 Participants |
| Acupressure Point P6 Stimulator | Vomiting During Stage III (After Replacement of the Uterus and to the Next 15 Minutes) | 6 Participants |
p-value: 0.2Chi-squared
p-value: 0.5Chi-squared
p-value: 0.7Chi-squared
Secondary
Vomiting During Stage IV (the Rest of the Time Until Arrival at PACU)
The investigators will perform objective assessments of whether or not the patients have vomited during stage IV. The investigators will then analyze if there is a statistically significant difference between the number of patients that vomit in each group.
Time frame: During the surgical procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Vomiting During Stage IV (the Rest of the Time Until Arrival at PACU) | 0 Participants |
| Metoclopramide, Ondansetron | Vomiting During Stage IV (the Rest of the Time Until Arrival at PACU) | 2 Participants |
| Acupressure Point P6 Stimulator | Vomiting During Stage IV (the Rest of the Time Until Arrival at PACU) | 0 Participants |
p-value: 1Chi-squared
p-value: 0.5Chi-squared
p-value: 0.5Chi-squared