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

NCT04801277 | Unknown DMC

• 1 other identifier: NMRR-19-3279-51524
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Nausea and Vomiting

Keywords

Electroacupuncture; Nausea vomiting; Caesarean Delivery

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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.

Procedure: Electroacupuncture on acupoints vs sham points

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)

Procedure: Electroacupuncture on acupoints vs sham points

Interventions

Electroacupuncture on acupoints vs sham points PROCEDURE

Randomized double blinded clinical trial

Acupuncture on PC6 and LI4; Acupuncture on Sham acupoints

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinical Research Centre, Malaysia: lead

Study Sites (1)

Hospital Raja Permaisuri Bainun Ipoh

Ipoh, Perak, 30450, Malaysia

RECRUITING

Related Publications (5)

• 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.

  PMID: 10320175 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.

  PMID: 28860857 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 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.

  PMID: 18043058 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.

  PMID: 11861340 RESULT

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Officials

• See Yun Chan

  Hospital Raja Permaisuri Bainun Ipoh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

See Yun Chan

CONTACT

+60125700148; seeyunchan@yahoo.com

Chek Ning Lee

CONTACT

+60125342845; chekning0606@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Obstetric Anaesthesiologist and acupuncturist

Model Details: Randomized double blinded

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: March 16, 2021
• Study Start: September 1, 2020
• Primary Completion: March 31, 2021
• Study Completion: April 30, 2021
• Last Updated: March 16, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)