An interventional study of Electroacupuncture on acupoints vs sham points in Postoperative Nausea and Vomiting, sponsored by Clinical Research Centre, Malaysia. Status unknown at 1 site in Malaysia. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-16.
Sponsored by Clinical Research Centre, Malaysia · Not applicable, Interventional, and Treatment
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
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.
822 studies on the registry are indexed under Nausea; 104 are open to participants now.
This study's planned enrollment of 100 is below the median of 115 across 703 interventional studies indexed under Nausea.
Browse Nausea studies →Clinical Research Centre, Malaysia is the lead sponsor of 28 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Procedure: Electroacupuncture on acupoints vs sham points
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)
Procedure: Electroacupuncture on acupoints vs sham points
Randomized double blinded clinical trial
Intraoperative nausea vomiting
Change in incidence
Time frame: Intraoperative 2 hours
Postoperative nausea vomiting
Change in incidence
Time frame: Immediate post operative
Postoperative nausea vomiting
Change in incidence
Time frame: 12 hours post operative
Postoperative nausea vomiting
Change in incidence
Time frame: 24 hours post operative
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Plan to share: No — Study Methodology
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Clinical Research Centre, Malaysia