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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture on PC6 and LI4 | Active Comparator | 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. |
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| Acupuncture on Sham acupoints | Sham Comparator | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroacupuncture on acupoints vs sham points | Procedure | Randomized double blinded clinical trial |
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| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative nausea vomiting | Change in incidence | Intraoperative 2 hours |
| Postoperative nausea vomiting | Change in incidence | Immediate post operative |
| Postoperative nausea vomiting | Change in incidence | 12 hours post operative |
| Postoperative nausea vomiting | Change in incidence | 24 hours post operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| See Yun Chan | Contact | +60125700148 | seeyunchan@yahoo.com | |
| Chek Ning Lee | Contact | +60125342845 | chekning0606@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| See Yun Chan | Hospital Raja Permaisuri Bainun Ipoh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Raja Permaisuri Bainun Ipoh | Recruiting | Ipoh | Perak | 30450 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10320175 | Background | 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. | |
| 28860857 | Background | 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. |
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Study Methodology
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 4, 2020 | Mar 10, 2021 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 4, 2020 | Mar 10, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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Randomized double blinded
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| 15935649 | Result | 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. |
| 18043058 | Result | 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. |
| 11861340 | Result | 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. |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |