Clinical trial NCT02960113
Conditions: Nausea Vomiting Satisfaction
Keywords: cesarean section acupressure point p6 scopolamine patch
Sponsor: Rutgers, The State University of New Jersey
Start date: 2016-05-01; Completion date: 2021-09-01
Enrollment: 240 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: 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. arm 2: Acupressure point P6 stimulation will be placed on the distal right forearm just above the crest of the wrist. arm 3: Will receive both scopolamine patch and acupressure point P6 stimulation, as described above.
Interventions: intervention 1: scopolamine patch intervention 2: acupressure point P6
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol documents:
ICF_002.pdf: 
 
 
Department of Anesthesiology and  
Perioperative Medicine 
Rutgers, The State University of New Jersey 
125 Paterson Street 
New Brunswick, NJ 08901-1977 
http://rwjanesthesiology.rwjms.rutgers.edu 
p. 732-235-7827 
f. 732-235-6131 
August 3, 2022 
 
Official Title: 
Reducing Nausea and Vomiting During Cesarean Section with Regional Anesthesia: Is the Application of 
Scopolamine Patch with or without Intra-operative Acupressure Point P6 Stimulation more effective than 
Intra-operative Acupressure Point P6 Stimulation alone? 
 
Document: 
Consent  
 
NCT02960113 
 
 
 
 
 

















Prot_000.pdf: 
Department of Anesthesiology and  
Perioperative Medicine 
Rutgers, The State University of New Jersey 
125 Paterson Street 
New Brunswick, NJ 08901-1977 
http://rwjanesthesiology.rwjms.rutgers.edu 
p. 732-235-7827
f. 732-235-6131
August 3, 2022 
Official Title: 
Reducing Nausea and Vomiting During Cesarean Section with Regional Anesthesia: Is the Application of 
Scopolamine Patch with or without Intra-operative Acupressure Point P6 Stimulation more effective than 
Intra-operative Acupressure Point P6 Stimulation alone? 
Document: 
Study Protocol 
NCT02960113





























SAP_001.pdf: 
 
 
 
Department of Biostatistics and Epidemiology  
School of Public Health 
683 Hoes Lane West 
Piscataway, NJ 08854 
sph.rutgers.edu 
p.732-235-4646 
f. 732-235-5476 
 
 
October 12, 2022 
 
Official Title: 
Reducing Nausea and Vomiting During Cesarean Section with Regional Anesthesia: Is the 
Application of Scopolamine Patch with or without Intra-operative Acupressure Point P6 
Stimulation more effective than Intra-operative Acupressure Point P6 Stimulation alone? 
 
Document: Statistical Analysis Plan 
 
NCT02960113 
 
 
 


 
Comments: 
The methods below are consistent with those mentioned in the protocol, after eliminating 
mention of unneeded procedures for looking at effectiveness of treatment.  The methods also 
clarify the adjustment for multiple testing on the two primary outcomes. 
 


 
Methods 
Means (standard deviations) were used to describe the distributions of continuous variables 
while frequencies (percentages) were used for categorical variables. Using intent-to-treat 
analyses, Analysis of Variance (ANOVA) was used to summarize the effect of treatment on 
satisfaction scores as well as ratings of nausea at time points 1 through 4 while chi-square was 
used for occurrence (yes/no) of nausea and vomiting overall all time points and vomiting at 
time points 1 through 4. 
 
A Bonferroni corrected p-value was calculated for the treatment effect on the two main 
outcomes, presence of vomiting and presence of nausea, such that an adjusted p-value from 
each test equaled the nominal p-value multiplied by 2.