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

• ClinicalTrials.gov Identifier: NCT03606525
• Recruitment Status: Unknown
• First Posted: July 31, 2018
• Last Update Posted: August 29, 2018
• Sponsor: University of Malaya
• Information provided by (Responsible Party): Dr Soo Suet Ker, University of Malaya

Study Description

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.

Condition or disease	Intervention/treatment
Effects of; Anesthesia, Spinal and Epidural, in Pregnancy	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 Design

• Study Type: Observational
• Estimated Enrollment: 130 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Correlation Between Vertebral Column Length (VCL), Abdominal Circumference (AC) and Spread of Intrathecal Hyperbaric Bupivacaine in the Term Parturient
• Actual Study Start Date: August 21, 2018
• Estimated Primary Completion Date: May 2019
• Estimated Study Completion Date: May 2019

Groups and Cohorts

Intervention Details:

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

Outcome Measures

Primary Outcome Measures :

1. sensory block level [ Time Frame: 15 minutes after subarachnoid injection ]
   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.

Secondary Outcome Measures :

1. blood pressure post subarachnoid block [ Time Frame: 2 hours ]
   Both systolic and diastolic blood pressure will be taken every 5 minutes until Caesarean section is completed
2. regression of subarachnoid block [ Time Frame: 1day ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: all term parturients going for elective Caesarean section
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

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

Criteria

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

Contacts and Locations

Contacts

Contact: Suet Ker Soo; +60122132070; suetker@gmail.com

Locations

Malaysia

University Malaya Medical Centre; Recruiting

Kuala Lumpur, Malaysia, 59100

Contact: Suet Ker Soo +60122132070 suetker@gmail.com

Contact: Yoo Kuen Chan +60379492052 yookuen@gmail.com

Sponsors and Collaborators

University of Malaya

Investigators

• Principal Investigator: Suet Ker Soo; University of Malaya

More Information

Additional Information:

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

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.

• Responsible Party: Dr Soo Suet Ker, Medical officer, Department of Anaesthesiology, Principal investigator, University of Malaya
• ClinicalTrials.gov Identifier: NCT03606525
• Other Study ID Numbers: 201843-6195
• First Posted: July 31, 2018
• Last Update Posted: August 29, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No