Effects of; Anesthesia, Spinal and Epidural, in PregnancyNCT03606525
Correlation Between VCL, AC and Spread of Intrathecal Hyperbaric Bupivacaine in the Term Parturient
An observational study of Effects of; Anesthesia, Spinal and Epidural, in Pregnancy, run by University of Malaya at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Effects of; Anesthesia, Spinal and Epidural, in Pregnancy
- What is being tested?
- subarachnoid block
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- 1 siteMalaysia
- Study dates
- 21 Aug 2018to May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: term parturients who are scheduled for elective Caesarean section under spinal anaesthesia in University Malaya Medical Centre
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
University Malaya Medical Centre
Kuala Lumpur, 59100
Suet Ker Soo, +60122132070, suetker@gmail.com
Yoo Kuen Chan, +60379492052, yookuen@gmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- subarachnoid block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subarachnoid blockProcedure or surgery
Vertebral column length and abdominal girth will be measured before routine subarachnoid block is given to recruited patients
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 minutes after subarachnoid injection
Secondary outcomes (2)
blood pressure post subarachnoid block
Both systolic and diastolic blood pressure will be taken every 5 minutes until Caesarean section is completed
Measured: 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.
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start21 Aug 2018
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Effects of; Anesthesia, Spinal and Epidural, in PregnancyStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Soo Suet Ker, University of Malaya
- Investigators
- Suet Ker Soo, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606525
- Sponsor's protocol ID
- 201843-6195
- Status last verified
- Aug 2018
- First submitted
- 2 Jul 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24806139Zhou 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.
PubMed 27009023
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Vertebral Column Length (VCL), Abdominal Circumference (AC) and Spread of Intrathecal Hyperbaric Bupivacaine in the Term Parturient
- ClinicalTrials.gov ID
- NCT03606525
- Acronym / sponsor ID
- 201843-6195
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 21 Aug 2018 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- term parturients who are scheduled for elective Caesarean section under spinal anaesthesia in University Malaya Medical Centre
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- patients with contraindication to subarachnoid block
- history of allergy to local anaesthetics
- contraindication to NSAIDS use
- failure of subarachnoid block
- any abnormality of spine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| subarachnoid blockVertebral column length and abdominal girth will be measured before routine subarachnoid block is given to recruited patients | Procedure or surgery | – |
Primary outcome
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.
2 secondary outcomes
blood pressure post subarachnoid block
Time frame: 2 hours
regression of subarachnoid block
Time frame: 1day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Background: PubMed 24806139Zhou 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.
- Background: PubMed 27009023Zhou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suet Ker Soo principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Effects of; Anesthesia, Spinal and Epidural, in Pregnancy, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suet Ker Soo (+60122132070, suetker@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensory block level (time frame: 15 minutes after subarachnoid injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03606525, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.