Correlation Between VCL, AC and Spread of Intrathecal Hyperbaric Bupivacaine in the Term Parturient

NCT03606525 | Unknown

• 1 other identifier: 201843-6195
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Currently there is no guideline to decide on the most appropriate dose of spinal anaesthesia. This study is planned to find out factors that influence the effect of spinal anaesthesia in pregnant mother going for Caesarean section and both the mother and baby's outcomes. Investigators will recruit pregnant mothers who are planned for elective Caesarean section under spinal anaesthesia at University Malaya Medical Centre before operation and obtained their consent to participate in this study. Routine standard care will be provided for all the participants. Perioperative data including vertebral column length and abdominal girth measured by measuring tape will be collected and analysed. There is no new intervention performed on participants.

Conditions

Effects of; Anesthesia, Spinal and Epidural, in Pregnancy

Outcome Measures

Primary Outcomes (1)

• sensory block level

  Pin-prick test will be performed in both midclavicular lines to determine to level of sensory blockade every 3 minutes. Highest level of sensory blockade will record at 15 minutes after intrathecal injection.

  15 minutes after subarachnoid injection

Secondary Outcomes (2)

• blood pressure post subarachnoid block

  2 hours

• regression of subarachnoid block

  1day

Interventions

subarachnoid block PROCEDURE

Vertebral column length and abdominal girth will be measured before routine subarachnoid block is given to recruited patients

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: all term parturients going for elective Caesarean section
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

term parturients who are scheduled for elective Caesarean section under spinal anaesthesia in University Malaya Medical Centre

You may qualify if:

• patients aged more than 18 years old
• American Society of Anesthesiologists (ASA) physical status I-II
• singleton pregnancy
• gestational age 37 weeks or more
• height 150-175cm and weight 50-100kg

You may not qualify if:

• patients with contraindication to subarachnoid block
• history of allergy to local anaesthetics
• contraindication to NSAIDS use
• failure of subarachnoid block
• any abnormality of spine
• history of spinal surgery
• refusal to participate in this research

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

RECRUITING

Related Publications (2)

• Zhou QH, Xiao WP, Shen YY. Abdominal girth, vertebral column length, and spread of spinal anesthesia in 30 minutes after plain bupivacaine 5 mg/mL. Anesth Analg. 2014 Jul;119(1):203-206. doi: 10.1213/ANE.0000000000000199.

  PMID: 24806139 BACKGROUND

• Zhou QH, Zhu B, Wei CN, Yan M. Abdominal girth and vertebral column length can adjust spinal anesthesia for lower limb surgery, a prospective, observational study. BMC Anesthesiol. 2016 Mar 24;16:22. doi: 10.1186/s12871-016-0184-3.

  PMID: 27009023 BACKGROUND

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Suet Ker Soo

  University of Malaya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suet Ker Soo

CONTACT

+60122132070; suetker@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical officer, Department of Anaesthesiology, Principal investigator

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 31, 2018
• Study Start: August 21, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: August 29, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)