Scopolamine Patch and Acupressure Point P6 Stimulation for Reduction of Nausea and Vomiting During Cesarean Section

NCT02960113 | Completed Phase 4 Results

• 1 other identifier: Pro20160000234
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea; Vomiting; Satisfaction

Keywords

cesarean section; acupressure point p6; scopolamine patch

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (9)

• Satisfaction With Intraoperative Antiemetic Treatment

  Throughout the surgical procedure

• Level of Nausea After the Administration of the Regional Anesthesia Medications

  From administration of anaesthesia until eversion of uterus

• Level of Nausea After Eversion of the Uterus

  After eversion of the uterus until replacement of the uterus

• Level of Nausea After Replacement of the Uterus

  After replacement of the uterus and to the next 15 minutes

• 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

Study Arms (3)

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.

Drug: scopolamine patch

acupressure point P6

EXPERIMENTAL

Acupressure point P6 stimulation will be placed on the distal right forearm just above the crest of the wrist.

Device: acupressure point P6

scopolamine patch + acupressure point P6

EXPERIMENTAL

Will receive both scopolamine patch and acupressure point P6 stimulation, as described above.

Drug: scopolamine patch; Device: acupressure point P6

Interventions

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.

Also known as: Transderm-Scop, Scopace, Maldemar

scopolamine patch; scopolamine patch + acupressure point P6

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.

acupressure point P6; scopolamine patch + acupressure point P6

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female subjects ages 18 to 45
• Subjects with ASA Class I or II
• Subjects with elective primary or repeat cesarean delivery
• Subjects who receive spinal and/or epidural anesthesia
• English and non-English speaking subjects will be included in the study

You may not qualify if:

• Female subjects \<18 years of age
• Subjects requiring emergent cesarean delivery
• Gestational age \< 37 weeks
• History of placenta accreta
• Multiple gestation pregnancy
• ASA status III or higher
• Current history of pregnancy induced hypertension, pre-eclampsia, or eclampsia
• History of any chronic medication use (other than prenatal vitamins), including inhaler medications
• Current urinary tract infection, pneumonia, or otitis media
• Coagulopathies or skin infections overlying the spine
• History of open angle glaucoma, seizures or psychosis

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (16)

• 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.

  PMID: 9054245 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.

  PMID: 11590314 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.

  PMID: 20391961 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.

  PMID: 23076903 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.

  PMID: 7893022 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.

  PMID: 15935649 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.

  PMID: 24497372 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.

  PMID: 25822385 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.

  PMID: 15947124 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.

  PMID: 21118734 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.

  PMID: 16175141 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.

  PMID: 19370583 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.

  PMID: 18806045 BACKGROUND

• Quinla JD, Hill DA. Nausea and vomiting of pregnancy. Am Fam Physician. 2003 Jul 1;68(1):121-8.

  PMID: 12887118 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.

  PMID: 8041539 BACKGROUND

• 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.

  PMID: 34002866 DERIVED

MeSH Terms

Conditions

Nausea; Vomiting; Personal Satisfaction

Interventions

Butylscopolammonium Bromide; Scopolamine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Belladonna Alkaloids; Solanaceous Alkaloids

Results Point of Contact

• Title: Shaul Cohen, MD
• Organization: Rutgers Robert Wood Johnson Medical School

chohensh@rwjms.rutgers.edu

732-235-8717

Study Officials

• Shaul Cohen, MD

  Robert Wood Johnson University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Obstetric Anesthesia

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: November 9, 2016
• Study Start: May 1, 2016
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: December 28, 2022
• Results First Posted: December 28, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)