Nausea, Vomiting, Satisfaction
Conditions
Keywords
cesarean section, acupressure point p6, scopolamine patch
Brief summary
The purpose of this study is to compare the effectiveness of reducing intra-cesarean section nausea and vomiting with regional anesthesia in subjects who will receive scopolamine patch with acupressure point P6 stimulation versus subjects that receive just scopolamine patch versus subjects that receive just acupressure point P6 stimulation.
Detailed description
Nausea and vomiting are very common and unpleasant events experienced during cesarean section under regional anesthesia and in the postoperative period following cesarean section. These side effects are distressing for both the parturient and her family. In addition, intraoperative vomiting causes significant challenges for the surgeon, such as increased procedure length, increased risk of bleeding, increased risk of gastric content aspiration, and potential surgical trauma. To combat the nausea and vomiting seen in all above anesthetic modalities, but to a greater degree in regional anesthesia, a number of pharmacological interventions are currently used with varying degrees of effectiveness in the perioperative period. These medications come from a wide range of drug classes including serotonin and dopamine receptor antagonists, corticosteroids, antihistamines, sedatives and anticholinergics. In our study, we would like to compare the effectiveness of antiemetic agents or technique which cause less severe adverse reactions to the mother and her fetus. Out of the available pharmacological agents for reduction of intra-cesarean section nausea and vomiting, transdermal scopolamine patch is one of the safest medications. We would like to compare the effectiveness of the transdermal scopolamine patch with acupressure point P6 stimulation versus just transdermal scopolamine patch versus just acupressure point P6 stimulation.
Interventions
Group I (n=80): Will receive scopolamine patch placement on the skin behind the right ear 1 hour before initiation of the regional anesthesia for the duration of surgery. The time of the application of the patch will be recorded, and the time of the start of the surgery will be recorded. The last time point for evaluation of patient's nausea/vomiting will be when the patient arrives to the post anesthesia care unit. A member of the research team will remove the patch from the patient and properly dispose the patch upon arrival to the post anesthesia care unit.
DEVICEacupressure point P6
Group II (n=80): Will receive acupressure 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 her 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
SINGLE (Outcomes Assessor)
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 ASA Class I or II 3. Subjects with elective primary or repeat cesarean delivery 4. Subjects who receive spinal and/or 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. Gestational age \< 37 weeks 4. History of placenta accreta 5. Multiple gestation pregnancy 6. ASA status III or higher 7. Current history of pregnancy induced hypertension, pre-eclampsia, or eclampsia 8. History of any chronic medication use (other than prenatal vitamins), including inhaler medications 9. Current urinary tract infection, pneumonia, or otitis media 10. Coagulopathies or skin infections overlying the spine 11. History of open angle glaucoma, seizures or psychosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Nausea | Throughout the entire 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. |
| Number of Patients With Vomiting | Throughout 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 |
|---|---|---|
| Level of Nausea After Eversion of the Uterus | After eversion of the uterus 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) after eversion of the uterus. 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. |
| Level of Nausea After Replacement of the Uterus | 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) after replacement of the uterus. 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. |
| Level of Nausea Upon Arrival to the Post-operative Recovery Room | 15 minutes after replacement of the uterus to arrival at post-anaesthesia care unit | Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) upon arrival to the post-operative recovery room. 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. |
| Satisfaction With Intraoperative Antiemetic Treatment | Throughout the surgical procedure | Patients are asked their nausea and vomiting treatment satisfaction (0 = Not Satisfied, 10 = Extremely Satisfied). Patients are also asked their overall satisfaction with the procedure (0 = Not Satisfied, 10 = Extremely Satisfied). |
| Number of Patients With Vomiting After Eversion of the Uterus | After eversion of to replacement of the uterus | Objective assessments of whether or not the patients have vomited at this point in the surgical procedure will be done. The investigators will analyze if there is a statistically significant difference between the number of patients that vomit in each group. |
| Number of Patients With Vomiting After Replacement of the Uterus | After replacement of the uterus and for next 15 minutes | Objective assessments of whether or not the patients have vomited at this point in the surgical procedure will be done. The investigators will analyze if there is a statistically significant difference between the number of patients that vomit in each group. |
| Number of Patients With Vomiting Upon Arrival to the Post-operative Recovery Room | From 15 minutes after replacement of the uterus until arrival at the post-anaesthesia care unit | Objective assessments of whether or not the patients have vomited at this point in the surgical procedure will be done. The investigators will analyze if there is a statistically significant difference between the number of patients that vomit in each group. |
| Number of Patients With Vomiting After the Administration of the Regional Anesthesia Medications | After the administration of the regional anesthesia medications until eversion of the uterus | Objective assessments of whether or not the patients have vomited at this point in the surgical procedure will be done. The investigators will analyze if there is a statistically significant difference between the number of patients that vomit in each group. |
| Level of Nausea After the Administration of the Regional Anesthesia Medications | From administration of anaesthesia until eversion of 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) after the administration of the regional anesthesia medications. 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 |
|---|---|
| Scopolamine Patch Scopolamine patch will be placed on the skin behind the right ear 1 hour before initiation of the regional anesthesia for the duration of surgery.
scopolamine patch: Group I (n=80): Will receive scopolamine patch placement on the skin behind the right ear 1 hour before initiation of the regional anesthesia for the duration of surgery. The time of the application of the patch will be recorded, and the time of the start of the surgery will be recorded. The last time point for evaluation of patient's nausea/vomiting will be when the patient arrives to the post anesthesia care unit. A member of the research team will remove the patch from the patient and properly dispose the patch upon arrival to the post anesthesia care unit. | 80 |
| Acupressure Point P6 Acupressure point P6 stimulation will be placed on the distal right forearm just above the crest of the wrist.
acupressure point P6: Group II (n=80): Will receive acupressure 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 her prior to administration of the standardized regional anesthesia. | 80 |
| Scopolamine Patch + Acupressure Point P6 Will receive both scopolamine patch and acupressure point P6 stimulation, as described above.
scopolamine patch: Group I (n=80): Will receive scopolamine patch placement on the skin behind the right ear 1 hour before initiation of the regional anesthesia for the duration of surgery. The time of the application of the patch will be recorded, and the time of the start of the surgery will be recorded. The last time point for evaluation of patient's nausea/vomiting will be when the patient arrives to the post anesthesia care unit. A member of the research team will remove the patch from the patient and properly dispose the patch upon arrival to the post anesthesia care unit.
acupressure point P6: Group II (n=80): Will receive acupressure 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 her prior to administration of the standardized regional anesthesia. | 80 |
| Total | 240 |
Baseline characteristics
| Characteristic | Acupressure Point P6 | Total | Scopolamine Patch | Scopolamine Patch + Acupressure Point P6 |
|---|---|---|---|---|
| Age, Continuous | 31.32 years STANDARD_DEVIATION 5.3 | 31.94 years STANDARD_DEVIATION 5.46 | 32.78 years STANDARD_DEVIATION 4.98 | 32.16 years STANDARD_DEVIATION 4.87 |
| Height | 64.3 inches STANDARD_DEVIATION 4.5 | 64.4 inches STANDARD_DEVIATION 4.4 | 64.7 inches STANDARD_DEVIATION 5 | 64.2 inches STANDARD_DEVIATION 3.6 |
| Race and Ethnicity Not Collected | — | 0 Participants | — | — |
| Sex: Female, Male Female | 80 Participants | 240 Participants | 80 Participants | 80 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Weight | 179.17 lbs STANDARD_DEVIATION 30.2 | 183.93 lbs STANDARD_DEVIATION 35.11 | 188.11 lbs STANDARD_DEVIATION 34.1 | 184.51 lbs STANDARD_DEVIATION 40.17 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 80 | 0 / 80 |
| other Total, other adverse events | 0 / 80 | 0 / 80 | 0 / 80 |
| serious Total, serious adverse events | 0 / 80 | 0 / 80 | 0 / 80 |
Outcome results
Primary
Number of Patients With 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: Throughout the entire surgical procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Scopolamine Patch | Number of Patients With Nausea | 40 Participants |
| Acupressure Point P6 | Number of Patients With Nausea | 39 Participants |
| Scopolamine Patch + Acupressure Point P6 | Number of Patients With Nausea | 46 Participants |
Comparison: Null hypothesis: Percent experiencing nausea equal between groupsp-value: 0.98Chi-squared
Primary
Number of Patients With 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: Throughout the surgical procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Scopolamine Patch | Number of Patients With Vomiting | 24 Participants |
| Acupressure Point P6 | Number of Patients With Vomiting | 25 Participants |
| Scopolamine Patch + Acupressure Point P6 | Number of Patients With Vomiting | 31 Participants |
Comparison: Null hypothesis: Percent experiencing vomiting equal across groupsp-value: 0.9Chi-squared
Secondary
Level of Nausea After 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) after eversion of the uterus. 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: After eversion of the uterus until replacement of the uterus
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Scopolamine Patch | Level of Nausea After Eversion of the Uterus | 1.28 units on a scale | Standard Deviation 3 |
| Acupressure Point P6 | Level of Nausea After Eversion of the Uterus | 1.09 units on a scale | Standard Deviation 2.82 |
| Scopolamine Patch + Acupressure Point P6 | Level of Nausea After Eversion of the Uterus | 1.40 units on a scale | Standard Deviation 3.27 |
Comparison: Null hypothesis: means equal across treatment groupsp-value: 0.8ANOVA
Secondary
Level of Nausea After 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) after replacement of the uterus. 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: After replacement of the uterus and to the next 15 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Scopolamine Patch | Level of Nausea After Replacement of the Uterus | 2.19 units on a scale | Standard Deviation 3.5 |
| Acupressure Point P6 | Level of Nausea After Replacement of the Uterus | 2.19 units on a scale | Standard Deviation 3.78 |
| Scopolamine Patch + Acupressure Point P6 | Level of Nausea After Replacement of the Uterus | 2.51 units on a scale | Standard Deviation 3.91 |
Comparison: Null hypothesis: means equal across treatment groupsp-value: 0.82ANOVA
Secondary
Level of Nausea After the Administration of the Regional Anesthesia Medications
Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) after the administration of the regional anesthesia medications. 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: From administration of anaesthesia until eversion of uterus
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Scopolamine Patch | Level of Nausea After the Administration of the Regional Anesthesia Medications | 2.71 units on a scale | Standard Deviation 4.02 |
| Acupressure Point P6 | Level of Nausea After the Administration of the Regional Anesthesia Medications | 2.57 units on a scale | Standard Deviation 3.84 |
| Scopolamine Patch + Acupressure Point P6 | Level of Nausea After the Administration of the Regional Anesthesia Medications | 2.84 units on a scale | Standard Deviation 3.99 |
p-value: 0.91ANOVA
Secondary
Level of Nausea Upon Arrival to the Post-operative Recovery Room
Patients offer their subjective assessments of the level of nausea on a scale of 0-10 (0 = no nausea, 10 = worst nausea ever experienced) upon arrival to the post-operative recovery room. 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: 15 minutes after replacement of the uterus to arrival at post-anaesthesia care unit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Scopolamine Patch | Level of Nausea Upon Arrival to the Post-operative Recovery Room | 0.18 units on a scale | Standard Deviation 1.11 |
| Acupressure Point P6 | Level of Nausea Upon Arrival to the Post-operative Recovery Room | 0.25 units on a scale | Standard Deviation 1.36 |
| Scopolamine Patch + Acupressure Point P6 | Level of Nausea Upon Arrival to the Post-operative Recovery Room | 0.23 units on a scale | Standard Deviation 1.42 |
Comparison: Null hypothesis: means equal across treatment groupsp-value: 0.93ANOVA
Secondary
Number of Patients With Vomiting After Eversion of the Uterus
Objective assessments of whether or not the patients have vomited at this point in the surgical procedure will be done. The investigators will analyze if there is a statistically significant difference between the number of patients that vomit in each group.
Time frame: After eversion of to replacement of the uterus
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Scopolamine Patch | Number of Patients With Vomiting After Eversion of the Uterus | 8 Participants |
| Acupressure Point P6 | Number of Patients With Vomiting After Eversion of the Uterus | 6 Participants |
| Scopolamine Patch + Acupressure Point P6 | Number of Patients With Vomiting After Eversion of the Uterus | 9 Participants |
Comparison: Null hypothesis: percent of vomiting equal across treatment groupsp-value: 0.71Chi-squared
Secondary
Number of Patients With Vomiting After Replacement of the Uterus
Objective assessments of whether or not the patients have vomited at this point in the surgical procedure will be done. The investigators will analyze if there is a statistically significant difference between the number of patients that vomit in each group.
Time frame: After replacement of the uterus and for next 15 minutes
Population: Missing information on one participant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Scopolamine Patch | Number of Patients With Vomiting After Replacement of the Uterus | 10 Participants |
| Acupressure Point P6 | Number of Patients With Vomiting After Replacement of the Uterus | 15 Participants |
| Scopolamine Patch + Acupressure Point P6 | Number of Patients With Vomiting After Replacement of the Uterus | 12 Participants |
Comparison: Null hypothesis: percent of vomiting equal across treatment groupsp-value: 0.55Chi-squared
Secondary
Number of Patients With Vomiting After the Administration of the Regional Anesthesia Medications
Objective assessments of whether or not the patients have vomited at this point in the surgical procedure will be done. The investigators will analyze if there is a statistically significant difference between the number of patients that vomit in each group.
Time frame: After the administration of the regional anesthesia medications until eversion of the uterus
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Scopolamine Patch | Number of Patients With Vomiting After the Administration of the Regional Anesthesia Medications | 20 Participants |
| Acupressure Point P6 | Number of Patients With Vomiting After the Administration of the Regional Anesthesia Medications | 15 Participants |
| Scopolamine Patch + Acupressure Point P6 | Number of Patients With Vomiting After the Administration of the Regional Anesthesia Medications | 20 Participants |
p-value: 0.55Chi-squared
Secondary
Number of Patients With Vomiting Upon Arrival to the Post-operative Recovery Room
Objective assessments of whether or not the patients have vomited at this point in the surgical procedure will be done. The investigators will analyze if there is a statistically significant difference between the number of patients that vomit in each group.
Time frame: From 15 minutes after replacement of the uterus until arrival at the post-anaesthesia care unit
Population: Missing information on four participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Scopolamine Patch | Number of Patients With Vomiting Upon Arrival to the Post-operative Recovery Room | 1 Participants |
| Acupressure Point P6 | Number of Patients With Vomiting Upon Arrival to the Post-operative Recovery Room | 1 Participants |
| Scopolamine Patch + Acupressure Point P6 | Number of Patients With Vomiting Upon Arrival to the Post-operative Recovery Room | 4 Participants |
Comparison: Null hypothesis: percent of vomiting equal across treatment groupsp-value: 0.2Chi-squared
Secondary
Satisfaction With Intraoperative Antiemetic Treatment
Patients are asked their nausea and vomiting treatment satisfaction (0 = Not Satisfied, 10 = Extremely Satisfied). Patients are also asked their overall satisfaction with the procedure (0 = Not Satisfied, 10 = Extremely Satisfied).
Time frame: Throughout the surgical procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Scopolamine Patch | Satisfaction With Intraoperative Antiemetic Treatment | 9.29 units on a scale | Standard Deviation 1.39 |
| Acupressure Point P6 | Satisfaction With Intraoperative Antiemetic Treatment | 8.96 units on a scale | Standard Deviation 9.59 |
| Scopolamine Patch + Acupressure Point P6 | Satisfaction With Intraoperative Antiemetic Treatment | 9.59 units on a scale | Standard Deviation 9.83 |
p-value: 0.026ANOVA