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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| scopolamine patch | Experimental | 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. |
|
| acupressure point P6 | Experimental | Acupressure point P6 stimulation will be placed on the distal right forearm just above the crest of the wrist. |
|
| scopolamine patch + acupressure point P6 | Experimental | Will receive both scopolamine patch and acupressure point P6 stimulation, as described above. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| scopolamine patch | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Throughout the entire surgical procedure |
| 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. | Throughout the surgical procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Throughout the surgical procedure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shaul Cohen, MD | Robert Wood Johnson University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08901 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9054245 | Background | Hawkins JL, Koonin LM, Palmer SK, Gibbs CP. Anesthesia-related deaths during obstetric delivery in the United States, 1979-1990. Anesthesiology. 1997 Feb;86(2):277-84. doi: 10.1097/00000542-199702000-00002. | |
| 11590314 | Background | Ezri T, Szmuk P, Evron S, Geva D, Hagay Z, Katz J. Difficult airway in obstetric anesthesia: a review. Obstet Gynecol Surv. 2001 Oct;56(10):631-41. doi: 10.1097/00006254-200110000-00022. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age is missing for one of the participants. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Throughout the entire surgical procedure |
|
Intraoperative
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shaul Cohen, MD | Rutgers Robert Wood Johnson Medical School | 732-235-8717 | chohensh@rwjms.rutgers.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 3, 2022 | Aug 4, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 12, 2022 | Nov 22, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 3, 2022 | Aug 4, 2022 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D009325 | Nausea |
| D014839 | Vomiting |
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D002086 | Butylscopolammonium Bromide |
| D012601 | Scopolamine |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D012602 | Scopolamine Derivatives |
Not provided
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|
|
| acupressure point P6 | Device | 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. |
|
| 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. |
| From administration of anaesthesia until eversion of uterus |
| 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. | After eversion of the uterus until replacement of the uterus |
| 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. | After replacement of the uterus and to the next 15 minutes |
| 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. | 15 minutes after replacement of the uterus to arrival at post-anaesthesia care unit |
| 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. | After the administration of the regional anesthesia medications until eversion of the uterus |
| 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. | After eversion of to replacement of the uterus |
| 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. | After replacement of the uterus and for next 15 minutes |
| 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. | From 15 minutes after replacement of the uterus until arrival at the post-anaesthesia care unit |
| 20391961 | Background | Malvasi A, Tinelli A, Stark M, Pontrelli G, Brizzi A, Wetzl RG, Benhamou D. Low-dose sequential combined spinal-epidural anaesthesia in elective Stark caesarean section: a preliminary cohort study. Eur Rev Med Pharmacol Sci. 2010 Mar;14(3):215-21. |
| 23076903 | Background | Afolabi BB, Lesi FE. Regional versus general anaesthesia for caesarean section. Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD004350. doi: 10.1002/14651858.CD004350.pub3. |
| 7893022 | Background | Riley ET, Cohen SE, Macario A, Desai JB, Ratner EF. Spinal versus epidural anesthesia for cesarean section: a comparison of time efficiency, costs, charges, and complications. Anesth Analg. 1995 Apr;80(4):709-12. doi: 10.1097/00000539-199504000-00010. |
| 15935649 | Background | Balki M, Carvalho JC. Intraoperative nausea and vomiting during cesarean section under regional anesthesia. Int J Obstet Anesth. 2005 Jul;14(3):230-41. doi: 10.1016/j.ijoa.2004.12.004. |
| 24497372 | Background | Paranjothy S, Griffiths JD, Broughton HK, Gyte GM, Brown HC, Thomas J. Interventions at caesarean section for reducing the risk of aspiration pneumonitis. Cochrane Database Syst Rev. 2014 Feb 5;2014(2):CD004943. doi: 10.1002/14651858.CD004943.pub4. |
| 25822385 | Background | Flake ZA, Linn BS, Hornecker JR. Practical selection of antiemetics in the ambulatory setting. Am Fam Physician. 2015 Mar 1;91(5):293-6. |
| 15947124 | Background | Golembiewski J, Chernin E, Chopra T. Prevention and treatment of postoperative nausea and vomiting. Am J Health Syst Pharm. 2005 Jun 15;62(12):1247-60; quiz 1261-2. doi: 10.1093/ajhp/62.12.1247. |
| 21118734 | Background | Apfel CC, Zhang K, George E, Shi S, Jalota L, Hornuss C, Fero KE, Heidrich F, Pergolizzi JV, Cakmakkaya OS, Kranke P. Transdermal scopolamine for the prevention of postoperative nausea and vomiting: a systematic review and meta-analysis. Clin Ther. 2010 Nov;32(12):1987-2002. doi: 10.1016/j.clinthera.2010.11.014. |
| 16175141 | Background | Renner UD, Oertel R, Kirch W. Pharmacokinetics and pharmacodynamics in clinical use of scopolamine. Ther Drug Monit. 2005 Oct;27(5):655-65. doi: 10.1097/01.ftd.0000168293.48226.57. |
| 19370583 | Background | Lee A, Fan LT. Stimulation of the wrist acupuncture point P6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD003281. doi: 10.1002/14651858.CD003281.pub3. |
| 18806045 | Background | Allen TK, Habib AS. P6 stimulation for the prevention of nausea and vomiting associated with cesarean delivery under neuraxial anesthesia: a systematic review of randomized controlled trials. Anesth Analg. 2008 Oct;107(4):1308-12. doi: 10.1213/ane.0b013e31816d1864. |
| 12887118 | Background | Quinla JD, Hill DA. Nausea and vomiting of pregnancy. Am Fam Physician. 2003 Jul 1;68(1):121-8. |
| 8041539 | Background | Belluomini J, Litt RC, Lee KA, Katz M. Acupressure for nausea and vomiting of pregnancy: a randomized, blinded study. Obstet Gynecol. 1994 Aug;84(2):245-8. |
| 34002866 | Derived | Griffiths JD, Gyte GM, Popham PA, Williams K, Paranjothy S, Broughton HK, Brown HC, Thomas J. Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. Cochrane Database Syst Rev. 2021 May 18;5(5):CD007579. doi: 10.1002/14651858.CD007579.pub3. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Height | Height measurement is missing for one observation. | Mean | Standard Deviation | inches |
|
| Weight | Mean | Standard Deviation | lbs |
|
| OG001 | 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. |
| OG002 | 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. |
|
|
|
| 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. | Posted | Count of Participants | Participants | Throughout the surgical procedure |
|
|
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | Throughout the surgical procedure |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | From administration of anaesthesia until eversion of uterus |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | After eversion of the uterus until replacement of the uterus |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | After replacement of the uterus and to the next 15 minutes |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 15 minutes after replacement of the uterus to arrival at post-anaesthesia care unit |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | After the administration of the regional anesthesia medications until eversion of the uterus |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | After eversion of to replacement of the uterus |
|
|
|
|
| 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. | Missing information on one participant. | Posted | Count of Participants | Participants | After replacement of the uterus and for next 15 minutes |
|
|
|
|
| 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. | Missing information on four participants. | Posted | Count of Participants | Participants | From 15 minutes after replacement of the uterus until arrival at the post-anaesthesia care unit |
|
|
|
|
| 0 |
| 80 |
| 0 |
| 80 |
| 0 |
| 80 |
| EG001 | 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. | 0 | 80 | 0 | 80 | 0 | 80 |
| EG002 | 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. | 0 | 80 | 0 | 80 | 0 | 80 |
Not provided
Not provided
Not provided
| D014326 |
| Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| Male |
|