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

Correlation Between Vertebral Column Length (VCL), Abdominal Circumference (AC) and Spread of Intrathecal Hyperbaric Bupivacaine in the Term Parturient

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.

Study Overview

• Status: Unknown
• Conditions: Effects of; Anesthesia, Spinal and Epidural, in Pregnancy
• Intervention / Treatment: Procedure: subarachnoid block

Detailed Description

The rising rate of caesarean section is a global phenomenon. Rate of caesarean section in Malaysia were 23.41% in 2011 and 25.08% in 2012. Subarachnoid block is the preferred anaesthetic technique for most lower segment caesarean section as compared to general anaesthesia. This is because general anaesthesia is associated with higher risk of failed endotracheal intubation and aspiration of gastric contents in parturients. Moreover, usage of pencil-point spinal needle had reduced the risk of postdural puncture headache frequency and severity.

Effective surgical anaesthesia is the main objective of subarachnoid block. Therefore, adequate sensory blockade with minimal maternal and neonate side effects are warranted. The suitable level of sensory blockade post subarachnoid block for lower segment caesarean section is bilateral block up to T6 dermatome level to pinprick. This will block the somatic sensation and eliminate the visceral pain from peritoneal manipulation during caesarean section.

However, the spread of subarachnoid block may be variable. Various patient variables such as age, height, weight, body mass index, vertebral column length and abdominal girth influence the spread of subarachnoid block. Inadequate sensory blockade will cause parturient suffer from pain while excessive blockade will lead to unwanted sympathetic inhibition causing hypotension and bradycardia. Ability of an anaesthetist to determine optimal dose to achieve adequate level of sensory blockade yet with minimal unwanted side effects is crucial.

Incidence of maternal hypotension is related to the level of sensory blockade after subarachnoid block.And maternal hypotension is associated with maternal discomfort during caesarean section and poorer fetal outcomes. Therefore, this study is carried out to investigate whether vertebral column length and abdominal circumference affecting the spread of intrathecal hyperbaric bupivacaine in term parturient.

Previous studies showed conflicting results on the factors that influence the effect of spinal anaesthesia. One of the studies was carried out in China which might not reflect the investigator's local multiracial population characteristics. Previous studies also did not investigate the outcome of baby related to maternal hypotension which is known complication.

• Study Type: Observational
• Enrollment (Anticipated): 130

Contacts and Locations

• Study Contact: Name: Suet Ker Soo; Phone Number: +60122132070; Email: suetker@gmail.com

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • Recruiting
    • University Malaya Medical Centre
    • Contact: Suet Ker Soo; Phone Number: +60122132070; Email: suetker@gmail.com
    • Contact: Yoo Kuen Chan; Phone Number: +60379492052; Email: yookuen@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood pressure post subarachnoid block	Both systolic and diastolic blood pressure will be taken every 5 minutes until Caesarean section is completed	2 hours
regression of subarachnoid block	Motor block will be assessed every hour until complete motor recovery or 6 hours after subarachnoid block, according to modified Bromage scale (Breen et al) as follows: 1= complete block (unable to move feet or knees); 2= almost complete block (able to move feet only); 3= partial block (just able to move knees); 4= detectable weakness of hip flexion while supine (full flexion of knees); 5= no detectable weakness of hip flexion while supine; 6= able to perform partial knee bend while assume standing position.	1day

Collaborators and Investigators

• Sponsor: University of Malaya
• Investigators: Principal Investigator: Suet Ker Soo, University of Malaya

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Correlation between spinal column length and the spread of subarachnoid hyperbaric bupivacaine in the term parturient

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 21, 2018
• Primary Completion (ANTICIPATED): May 1, 2019
• Study Completion (ANTICIPATED): May 1, 2019

Study Registration Dates

• First Submitted: July 2, 2018
• First Submitted That Met QC Criteria: July 30, 2018
• First Posted (ACTUAL): July 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 201843-6195

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No