Ignite Creation Date:
2024-05-06 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03606525
Status:
UNKNOWN
Last Update Posted:
2018-08-29
First Post:
2018-07-02
Brief Title:
Correlation Between VCL AC and Spread of Intrathecal Hyperbaric Bupivacaine in the Term Parturient
Sponsor:
University of Malaya
Organization:
University of Malaya
Study Overview
Official Title:
Correlation Between Vertebral Column Length VCL Abdominal Circumference AC and Spread of Intrathecal Hyperbaric Bupivacaine in the Term Parturient
Status:
UNKNOWN
Status Verified Date:
2018-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 babys 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
Detailed Description:
The rising rate of caesarean section is a global phenomenon Rate of caesarean section in Malaysia were 2341 in 2011 and 2508 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 blockAnd 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 investigators local multiracial population characteristics Previous studies also did not investigate the outcome of baby related to maternal hypotension which is known complication
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 blockAnd 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 investigators local multiracial population characteristics Previous studies also did not investigate the outcome of baby related to maternal hypotension which is known complication
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None