Effect of Different Left Lateral Table Tilt for Elective Cesarean Delivery Under Spinal Anesthesia

NCT04083768 | Completed

• 1 other identifier: XYFY2019-KL126-02
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The recommended position of the mother under caesarean section after spinal anesthesia is 15 degrees left. However, recent research has challenged the basic principles and practicality of the left-turn 15 degree position. Higuchi et al used nuclear magnetic imaging to directly prove that in the supine position, the position of the full-left 30 degrees of the full-term pregnancy of the full-term pregnancy relieved the inferior vena cava compression and the left-angle of 15 degrees did not. Therefore, there are more and more controversies about the choice of cesarean section position. This experiment aims to explore effects of different positions (15 degrees left, 30 degrees left and supine) for elective cesarean section on lumbar anesthesia for fetal acid-base balance and maternal Hemodynamic.

Conditions

Elective Cesarean Section; Spinal Anesthesia

Keywords

Position

Outcome Measures

Primary Outcomes (1)

• Umbilical artery blood pH

  Use a blood gas analyzer to measure

  Immediately after delivery

Secondary Outcomes (12)

• Other UA and UV blood gas analysis values（pH, base excess, lactate , Umbilical artery blood PaCO2

  Immediately after delivery

• Fetal Apgar score (1 minute after birth) And 5 minutes

  One minute and five minutes after the baby is delivered

• The incidence of nausea in pregnant women

  Intraoperative

• The incidence of vomiting in pregnant women

  Intraoperative

• The incidence of hypotension in pregnant women

  Intraoperative

Study Arms (3)

Supine group

PLACEBO COMPARATOR

After the patient completes the spinal anesthesia, the cesarean section is completed in the supine position.

Device: 15° and 30° wedge sponges

15° group

ACTIVE COMPARATOR

After the patient completed the spinal anesthesia, the preoperative preparation (about 10 minutes) was completed with a left tilt of 15°, and the cesarean section was completed using the supine position after the skin was cut.

Device: 15° and 30° wedge sponges

30° group

ACTIVE COMPARATOR

After the patient completed the spinal anesthesia, the preoperative preparation (about 10 minutes) was completed with a left tilt of 30°, and the cesarean section was completed using the supine position after the skin was cut.

Device: 15° and 30° wedge sponges

Interventions

15° and 30° wedge sponges DEVICE

After the spinal anesthesia is completed, the wedge sponge is placed between the patient's pelvis and ribs and the wedge is removed before the skin is cut.

15° group; 30° group; Supine group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton pregnancy at term via elective cesarean section
• Height from 150 cm to 180 cm
• American Society of Anesthesiologists (ASA) grade from I to II grade
• BMI（Body Mass Index，mearsured weight divided by height squared）less than 35 kg/m2.

You may not qualify if:

• Transverse lie
• Fetal macrosomia
• Uterine abnormalities (e.g., large fibroids, bicornuate uterus)
• Polyhydramnios
• Ruptured membranes
• Oligohydramnios
• Intrauterine growth restriction
• Gestational or nongestational hypertension, diabetes, eclampsia
• Hypertensive disorder or any condition associated with autonomic neuropathy (e.g., diabetes mellitus for more than 10 yr), with renal failure
• Have contraindications for spinal anesthesia（Such as low back infection, spinal deformity, etc.）
• Participants refused to sign informed consent.

Sponsors & Collaborators

• Xuzhou Medical University: lead

Study Sites (1)

Liu Tian yu

Xuzhou, Jiangsu, 221000, China

Location

Related Publications (5)

• Fujita N, Higuchi H, Sakuma S, Takagi S, Latif MAHM, Ozaki M. Effect of Right-Lateral Versus Left-Lateral Tilt Position on Compression of the Inferior Vena Cava in Pregnant Women Determined by Magnetic Resonance Imaging. Anesth Analg. 2019 Jun;128(6):1217-1222. doi: 10.1213/ANE.0000000000004166.

  PMID: 31094791 BACKGROUND

• Shayegan B, Khorasani A, Knezevic NN. Left Lateral Table Tilt for Elective Cesarean Delivery under Spinal Anesthesia Should Not Be Abandoned. Anesthesiology. 2018 Apr;128(4):860-861. doi: 10.1097/ALN.0000000000002095. No abstract available.

  PMID: 29533301 BACKGROUND

• Abengochea A, Morales-Rosello J, Del Rio-Vellosillo M, Argente P, Barbera M. Effect of lateral tilt angle on the volume of the abdominal aorta and inferior vena cava in pregnant and nonpregnant women determined by magnetic resonance imaging. Anesthesiology. 2015 Sep;123(3):733-4. doi: 10.1097/ALN.0000000000000791. No abstract available.

  PMID: 26284869 BACKGROUND

• Crawford JS, Burton M, Davies P. Time and lateral tilt at Caesarean section. Br J Anaesth. 1972 May;44(5):477-84. doi: 10.1093/bja/44.5.477. No abstract available.

  PMID: 5044078 RESULT

• Liu T, Zou S, Guo L, Niu Z, Wang M, Xu C, Gao X, Shi Z, Guo X, Xiao H, Qi D. Effect of Different Positions During Surgical Preparation With Combined Spinal-Epidural Anesthesia for Elective Cesarean Delivery: A Randomized Controlled Trial. Anesth Analg. 2021 Nov 1;133(5):1235-1243. doi: 10.1213/ANE.0000000000005320.

  PMID: 33350619 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: September 10, 2019
• Study Start: October 1, 2019
• Primary Completion: January 31, 2020
• Study Completion: February 10, 2020
• Last Updated: June 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)