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Efficacy of PC6 Electroacupuncture in the Prevention of Nausea Vomiting in Caesarean Patient Under Spinal Anaesthesia

Primary Purpose

Postoperative Nausea and Vomiting

Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Electroacupuncture on acupoints vs sham points
Sponsored by
Clinical Research Centre, Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Nausea and Vomiting focused on measuring Electroacupuncture, Nausea vomiting, Caesarean Delivery

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Parturients (36-42 weeks pregnant) aged 18-45 undergoing planned for Caesarean Section.
  • American Society of Anaesthesiology class II patients only

Exclusion Criteria:

  • Patients with a previous history of PONV or nausea and vomiting in the preceding 24 hours
  • Patients who required emergent surgery where delay is inappropriate and can compromise mother and foetus, e.g. foetal distress, foetal bradycardia, chorioamnionitis, cord prolapse, severe preeclampsia
  • Patients with documented or known history of allergy to granisetron
  • Morbid obesity (BMI>40) as morbid obesity patient will be not be given intrathecal morphine due to increase risk of post operative respiratory depression.
  • Patients using any antiemetic drug including dexamethasone for 24 hours prior to Caesarean section (CS)
  • Patient who had an implanted pacemaker or defibrillator device. (safety of the use of electroacupuncture on these patient is questionable)
  • Patient who received opioids prior to CS (opioid is known to have nausea and vomiting side effect)
  • Patient refusal
  • Severe preeclampsia, gestational diabetes mellitus on treatment, neurological or cardiac disease.

Sites / Locations

  • Hospital Raja Permaisuri Bainun IpohRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Acupuncture on PC6 and LI4

Acupuncture on Sham acupoints

Arm Description

Acupuncture on bilateral acupoints, that are PC6 and LI4. The pericardium meridian PC6 point (Neiguan) is defined as follows. The patient's four fingerbreadths will be placed on the medial aspect of their forearm with the edge of the 4th finger on the wrist crease. This is then subtracted from the width of the interphalangeal joint of her thumb. The point between the tendons of extensor carpi radialis and palmaris longus was the pericardium meridian PC6 point (Neiguan). The large intestine LI4 point (Hegu) located on the dorsum of the hand, between the first and second metacarpal bones, at the midpoint of the second metacarpal bone and close to its radial border.

Acupuncture on bilateral non acupoints. In sham/placebo group, patient will have the acupuncture needles inserted at non-acupoint 2cm radial to PC6 and between 2nd and 3rd metacarpal bone bilaterally, superficial skin piercing (adequate depth to let patient feels needle is inserted)

Outcomes

Primary Outcome Measures

Intraoperative nausea vomiting
Change in incidence
Postoperative nausea vomiting
Change in incidence
Postoperative nausea vomiting
Change in incidence
Postoperative nausea vomiting
Change in incidence

Secondary Outcome Measures

Full Information

First Posted
December 7, 2020
Last Updated
March 14, 2021
Sponsor
Clinical Research Centre, Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT04801277
Brief Title
Efficacy of PC6 Electroacupuncture in the Prevention of Nausea Vomiting in Caesarean Patient Under Spinal Anaesthesia
Official Title
Efficacy of PC6 Electroacupuncture in the Prevention of Nausea Vomiting in Caesarean Patient Under Spinal Anaesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
March 31, 2021 (Anticipated)
Study Completion Date
April 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinical Research Centre, Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine the ability of electroacupuncture on PC6 versus sham acupuncture in reducing incidence of intraoperative and postoperative nausea vomiting in parturients who underwent Caesarean delivery under spinal anaesthesia
Detailed Description
Caesarean rate in most countries are increasing year by year. A report shows that the caesarean section rate for government hospitals in Malaysia was 10.5% in 2000 and 11.0% in 20011 and it rises to 25% of total delivery in Hospital Raja Permaisuri Bainun, Malaysia in year 2018. Nowadays, about 7% of all surgical procedures worldwide are caesarean section and the majority of them are performed with neuraxial blockade, ie epidural anesthesia, spinal anesthesia, or a combined spinal-epidural anesthesia (CSE). Nausea and vomiting are common intraoperative and postoperative complications in women having caesarean section under neuraxial anesthesia.Compared to the plethora of literatures about PONV, little attention has been paid to nausea vomiting occurring during or after regional anesthesia. These techniques gain increasing attention. Current literature review indicates a high incidence of IONV during CS under spinal anesthesia up to 80%4. The etiology of intraoperative and postoperative nausea and vomiting (IONV and PONV) is multifactorial. Pregnant women are already likely to suffer from nausea and vomiting because of the pregnancy itself. According to Apfel's score predictive of PONV score that consists of four ascertained risk factors (female, non-smoker, opioid use, previous PONV events or motion sickness), parturients often meet at least two of these criteria with their gender and non-smoker status. Despite the practice of prescribing antiemetic prophylaxis medication, the incidence of nausea and vomiting in CS patient is still up to 30-50%6. The efficacy of antiemetic drugs is limited and their administration is not free from side effects. Nausea and vomiting not only causes dehydration, electrolyte imbalance and adversely affects wound healing, but also leads to increased wound pain, discomfort, and anxiety among post partum patient. This may further lead to increased medical expenses and extended hospital stay, leaving patient with the overall negative surgical experience. Hence, the idea of multimodal therapy in prophylaxis of IONV and PONV arises. Non-pharmacological techiniques such as acupuncture, acupressure,and transcutaneous acupoint electrical stimulation of the pericardium 6(PC6) Neiguan point have been studied for the prevention of PONV. The increasing popularity of these modalities is, in part, due to their low cost, simplicity, and in obstetrics, concern about placental transfer and secretion in breast milk of drugs. It is hypothesized that PC6 electroacupunture stimulation will reduce the incidence of IONV and PONV and reduce the usage of antiemetic drugs in post partum patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
Electroacupuncture, Nausea vomiting, Caesarean Delivery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized double blinded
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture on PC6 and LI4
Arm Type
Active Comparator
Arm Description
Acupuncture on bilateral acupoints, that are PC6 and LI4. The pericardium meridian PC6 point (Neiguan) is defined as follows. The patient's four fingerbreadths will be placed on the medial aspect of their forearm with the edge of the 4th finger on the wrist crease. This is then subtracted from the width of the interphalangeal joint of her thumb. The point between the tendons of extensor carpi radialis and palmaris longus was the pericardium meridian PC6 point (Neiguan). The large intestine LI4 point (Hegu) located on the dorsum of the hand, between the first and second metacarpal bones, at the midpoint of the second metacarpal bone and close to its radial border.
Arm Title
Acupuncture on Sham acupoints
Arm Type
Sham Comparator
Arm Description
Acupuncture on bilateral non acupoints. In sham/placebo group, patient will have the acupuncture needles inserted at non-acupoint 2cm radial to PC6 and between 2nd and 3rd metacarpal bone bilaterally, superficial skin piercing (adequate depth to let patient feels needle is inserted)
Intervention Type
Procedure
Intervention Name(s)
Electroacupuncture on acupoints vs sham points
Intervention Description
Randomized double blinded clinical trial
Primary Outcome Measure Information:
Title
Intraoperative nausea vomiting
Description
Change in incidence
Time Frame
Intraoperative 2 hours
Title
Postoperative nausea vomiting
Description
Change in incidence
Time Frame
Immediate post operative
Title
Postoperative nausea vomiting
Description
Change in incidence
Time Frame
12 hours post operative
Title
Postoperative nausea vomiting
Description
Change in incidence
Time Frame
24 hours post operative

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Parturients (36-42 weeks pregnant) aged 18-45 undergoing planned for Caesarean Section. American Society of Anaesthesiology class II patients only Exclusion Criteria: Patients with a previous history of PONV or nausea and vomiting in the preceding 24 hours Patients who required emergent surgery where delay is inappropriate and can compromise mother and foetus, e.g. foetal distress, foetal bradycardia, chorioamnionitis, cord prolapse, severe preeclampsia Patients with documented or known history of allergy to granisetron Morbid obesity (BMI>40) as morbid obesity patient will be not be given intrathecal morphine due to increase risk of post operative respiratory depression. Patients using any antiemetic drug including dexamethasone for 24 hours prior to Caesarean section (CS) Patient who had an implanted pacemaker or defibrillator device. (safety of the use of electroacupuncture on these patient is questionable) Patient who received opioids prior to CS (opioid is known to have nausea and vomiting side effect) Patient refusal Severe preeclampsia, gestational diabetes mellitus on treatment, neurological or cardiac disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
See Yun Chan
Phone
+60125700148
Email
seeyunchan@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chek Ning Lee
Phone
+60125342845
Email
chekning0606@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
See Yun Chan
Organizational Affiliation
Hospital Raja Permaisuri Bainun Ipoh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Raja Permaisuri Bainun Ipoh
City
Ipoh
State/Province
Perak
ZIP/Postal Code
30450
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
See Yun Chan
Phone
+60125700148
Email
seeyunchan@yahoo.com
First Name & Middle Initial & Last Name & Degree
See Yun Chan
First Name & Middle Initial & Last Name & Degree
Chek Ning Lee

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Study Methodology
Citations:
PubMed Identifier
10320175
Citation
Macario A, Weinger M, Truong P, Lee M. Which clinical anesthesia outcomes are both common and important to avoid? The perspective of a panel of expert anesthesiologists. Anesth Analg. 1999 May;88(5):1085-91. doi: 10.1097/00000539-199905000-00023.
Results Reference
background
PubMed Identifier
28860857
Citation
Jelting Y, Klein C, Harlander T, Eberhart L, Roewer N, Kranke P. Preventing nausea and vomiting in women undergoing regional anesthesia for cesarean section: challenges and solutions. Local Reg Anesth. 2017 Aug 9;10:83-90. doi: 10.2147/LRA.S111459. eCollection 2017.
Results Reference
background
PubMed Identifier
15935649
Citation
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.
Results Reference
result
PubMed Identifier
18043058
Citation
Arnberger M, Stadelmann K, Alischer P, Ponert R, Melber A, Greif R. Monitoring of neuromuscular blockade at the P6 acupuncture point reduces the incidence of postoperative nausea and vomiting. Anesthesiology. 2007 Dec;107(6):903-8. doi: 10.1097/01.anes.0000290617.98058.d9.
Results Reference
result
PubMed Identifier
11861340
Citation
Pierre S, Benais H, Pouymayou J. Apfel's simplified score may favourably predict the risk of postoperative nausea and vomiting. Can J Anaesth. 2002 Mar;49(3):237-42. doi: 10.1007/BF03020521.
Results Reference
result

Learn more about this trial

Efficacy of PC6 Electroacupuncture in the Prevention of Nausea Vomiting in Caesarean Patient Under Spinal Anaesthesia

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