Comparison of Successful Spinal Needle Insertion Between Obese and Non-obese Pregnant Women

Caesarian Section Clinical Trial

Official title:

Comparison of Successful Spinal Needle Insertion Between Obese and Non-obese Pregnant Women in Crossed Leg Sitting Position Undergoing Caesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03054233
• Other study ID #: IndonesiaUAnes010
• Status: Completed
• Phase: N/A
• First received: February 13, 2017
• Last updated: February 15, 2017
• Start date: July 2016
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aimed to compare successful spinal needle insertion between obese and non-obese pregnant women in crossed leg sitting position undergoing cesarean section

Description:

Approval from Ethical Committee of Faculty of Medicine University of Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study.Subjects sat in cross leg sitting position: patients sit with both thighs abducted, knees flexed medially, each feet soles were under their contralateral thighs. The back was flexed maximally, subjects' chin approaching the sternum, and subjects hugged a pillow. Lumbal puncture was done using Quincke needle 25G/27G at L4-5 intervertebral gap until the it reached subarachnoid space (confirmed by free flow cerebrospinal fluid). Data recorded were the number of attempt for the successful spinal puncture, the number of spinal needle-bone contact and blood vessel puncture incidence. Data was analyzed by using Statistical Package for Social Scientist (SPSS), for numerical data using unpaired T-test or Mann-Whitney-U test, for categorical data using Chi-square test or Fischer Exact's Test. Data normality was tested by Kolmogorov-Smirnov test. Significant value is p<0.05.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Subjects aged 18-45 years old, with American Society of Anesthesiologists (ASA) physical status I-III who were planned to undergo caesarian section with spinal anesthesia in crossed leg sitting position.

• Subjects have been explained about the study, have agreed to enroll and have signed the informed consent form

Exclusion Criteria:

• Subjects with contraindications for spinal anesthesia

• Subjects with fetal's head trapped, umbilical prolapse, and foot presentation

• Subjects with pre-eclampsia

• Subjects with cardiovascular diseases

• Subjects with scoliosis

• Subjects with recent lumbal surgery history

• Subjects who cannot sit in crossed leg sitting position.

Drop out criteria:

• Subjects with worsening conditions before spinal anesthesia

• Subjects with failed spinal needle insertion and thus received general anesthesia

• Subjects with twin pregnancy

• Subjects drop out the study.

Related Conditions & MeSH terms

• Caesarian Section

Intervention

Procedure:
• Crossed leg sitting position
Spinal anesthesia done in crossed leg sitting position

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Central National Hospital	Central Jakarta	DKI Jakarta
Indonesia	Cipto Mangunkusumo Cental National Hospital	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (16)

American College of Obstetricians and Gynecologists.. ACOG Committee opinion no. 549: obesity in pregnancy. Obstet Gynecol. 2013 Jan;121(1):213-7. doi: http://10.1097/01.AOG.0000425667.10377.60. — View Citation

Anuurad E, Shiwaku K, Nogi A, Kitajima K, Enkhmaa B, Shimono K, Yamane Y. The new BMI criteria for asians by the regional office for the western pacific region of WHO are suitable for screening of overweight to prevent metabolic syndrome in elder Japanese workers. J Occup Health. 2003 Nov;45(6):335-43. — View Citation

Broadbent CR, Maxwell WB, Ferrie R, Wilson DJ, Gawne-Cain M, Russell R. Ability of anaesthetists to identify a marked lumbar interspace. Anaesthesia. 2000 Nov;55(11):1122-6. — View Citation

Cadi P, Guenoun T, Journois D, Chevallier JM, Diehl JL, Safran D. Pressure-controlled ventilation improves oxygenation during laparoscopic obesity surgery compared with volume-controlled ventilation. Br J Anaesth. 2008 May;100(5):709-16. doi: 10.1093/bja/aen067. — View Citation

Collins JS, Lemmens HJ, Brodsky JB, Brock-Utne JG, Levitan RM. Laryngoscopy and morbid obesity: a comparison of the "sniff" and "ramped" positions. Obes Surg. 2004 Oct;14(9):1171-5. — View Citation

Davies GA, Maxwell C, McLeod L, Gagnon R, Basso M, Bos H, Delisle MF, Farine D, Hudon L, Menticoglou S, Mundle W, Murphy-Kaulbeck L, Ouellet A, Pressey T, Roggensack A, Leduc D, Ballerman C, Biringer A, Duperron L, Jones D, Lee LS, Shepherd D, Wilson K; Society of Obstetricians and Gynaecologists of Canada.. SOGC Clinical Practice Guidelines: Obesity in pregnancy. No. 239, February 2010. Int J Gynaecol Obstet. 2010 Aug;110(2):167-73. — View Citation

Gulay U, Meltem T, Nadir SS, Aysin A. Ultrasound-guided evaluation of the lumbar subarachnoid space in lateral and sitting positions in pregnant patients to receive elective cesarean operation. Pak J Med Sci. 2015 Jan-Feb;31(1):76-81. doi: 10.12669/pjms.311.5647. — View Citation

Kim SH, Kim DY, Han JI, Baik HJ, Park HS, Lee GY, Kim JH. Vertebral level of Tuffier's line measured by ultrasonography in parturients in the lateral decubitus position. Korean J Anesthesiol. 2014 Sep;67(3):181-5. doi: 10.4097/kjae.2014.67.3.181. — View Citation

McKay RE, Malhotra A, Cakmakkaya OS, Hall KT, McKay WR, Apfel CC. Effect of increased body mass index and anaesthetic duration on recovery of protective airway reflexes after sevoflurane vs desflurane. Br J Anaesth. 2010 Feb;104(2):175-82. doi: 10.1093/bja/aep374. — View Citation

Mhyre JM. Anesthetic management for the morbidly obese pregnant woman. Int Anesthesiol Clin. 2007 Winter;45(1):51-70. Review. — View Citation

Reinius H, Jonsson L, Gustafsson S, Sundbom M, Duvernoy O, Pelosi P, Hedenstierna G, Fredén F. Prevention of atelectasis in morbidly obese patients during general anesthesia and paralysis: a computerized tomography study. Anesthesiology. 2009 Nov;111(5):979-87. doi: 10.1097/ALN.0b013e3181b87edb. — View Citation

Rodrigues FR, Brandão MJ. Regional anesthesia for cesarean section in obese pregnant women: a retrospective study. Rev Bras Anestesiol. 2011 Jan-Feb;61(1):13-20. doi: 10.1016/S0034-7094(11)70002-2. — View Citation

Sebire NJ, Jolly M, Harris JP, Wadsworth J, Joffe M, Beard RW, Regan L, Robinson S. Maternal obesity and pregnancy outcome: a study of 287,213 pregnancies in London. Int J Obes Relat Metab Disord. 2001 Aug;25(8):1175-82. — View Citation

Soltani Mohammadi S, Hassani M, Marashi SM. Comparing the squatting position and traditional sitting position for ease of spinal needle placement: a randomized clinical trial. Anesth Pain Med. 2014 Apr 5;4(2):e13969. doi: 10.5812/aapm.13969. — View Citation

Vricella LK, Louis JM, Mercer BM, Bolden N. Anesthesia complications during scheduled cesarean delivery for morbidly obese women. Am J Obstet Gynecol. 2010 Sep;203(3):276.e1-5. doi: 10.1016/j.ajog.2010.06.022. — View Citation

Watanabe S, Kobara K, Ishida H, Eguchi A. Influence of trunk muscle co-contraction on spinal curvature during sitting cross-legged. Electromyogr Clin Neurophysiol. 2010 Apr-Jun;50(3-4):187-92. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of successful spinal needle placement in the first attempt	The number of successful spinal needle placement in the first attempt was recorded in yes/no method.	2 months
Primary	The number of needle-bone contact	The number of spinal needle-bone contact	2 months
Secondary	The number of blood vessel puncture incidence.	The number of blood vessel puncture incidence by the spinal needle during insertion.	2 months