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

Effects of; Anesthesia, Spinal and Epidural, in Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03606525
• Other study ID #: 201843-6195
• Status: Recruiting
• Start date: August 21, 2018
• Est. completion date: May 2019

Study information

• Verified date: August 2018
• Source: University of Malaya
• Contact: Suet Ker Soo
• Phone: +60122132070
• Email: suetker[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Effects of; Anesthesia, Spinal and Epidural, in Pregnancy

Intervention

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

Locations

Country	Name	City	State
Malaysia	University Malaya Medical Centre	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & 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):203-6. doi: 10.1213/ANE.0000000000000199. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	blood pressure post subarachnoid block	Both systolic and diastolic blood pressure will be taken every 5 minutes until Caesarean section is completed	2 hours
Secondary	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

External Links

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