Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05846100
Status:
RECRUITING
Last Update Posted:
2023-05-06
First Post:
2023-04-26
Brief Title:
Conventional Palpation Versus Ultrasound Assisted Spinal Anesthesia in Obstetrics
Sponsor:
Mongi Slim Hospital
Organization:
Mongi Slim Hospital
Study Overview
Official Title:
Conventional Palpation Versus Ultrasound Assisted Spinal Anesthesia in Obstetrics A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
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:
Spinal anesthesia in obese parturients is commonly difficult yet there are no guidelines to direct best practice The failure leads to suboptimal patient outcomes
Ultrasonography is now considered standard care for central venous access and regional anesthesia and it can be used to visualize the anatomy of the spine for this procedure
Goal of the study
Evaluate the benefits of preprocedural ultrasound scanning to facilitate neuraxial anesthesia and improve the first-attempt success rate in obese parturients
Ultrasonography is now considered standard care for central venous access and regional anesthesia and it can be used to visualize the anatomy of the spine for this procedure
Goal of the study
Evaluate the benefits of preprocedural ultrasound scanning to facilitate neuraxial anesthesia and improve the first-attempt success rate in obese parturients
Detailed Description:
This was a prospective randomized controlled trial conducted between Nov 2022 and December 2022 in the gynecological operating room of Mongi Slim hospital
Ethical approval was provided by our Institutional Hospital Ethics Committee
Written informed consent was obtained from all the participants
Study population
1 Inclusion criteria
Age 18 years old
Normal singleton pregnancy
Gestational age 37 weeks
BMI 30 Kg m2 weight measured on the day before delivery
Planned cesarean section
ASA 2-3
2 Non-inclusion criteria
Patient refusal to participate or unable to provide consent
Emergency cesarean section
patient pregnant with twins
Contraindications to spinal anesthesia
Localized sepsis infection at the puncture site
allergy to any of the drugs planned fo administration
raised intracranial pressure
spine surgery
aortic stenosis
Coagulopathy
hypovolemia
3 Exclusion criteria
Spinal anesthesia failure
Poorly Tolerated spinal anesthesia
Methods
All eligible participants scheduled for cesarean delivery were prospectively randomized to 2 groups using computer-generated random numbers
A standard manual palpation group standard group n45 and a pre-puncture ultrasound-guided neuraxial anesthesia group ultrasound group n45
The sample size calculation was based on a previous study 1 the first-attempt success rate was 52 in the conventional approach and 87 in the ultrasound group
With an α error of 5 and a ß error of 20 80 power a sample size of 43 patients per group was required We increased the number to 45 per group to allow dropouts
The weight height and BMI of the parturients were measured one day before the delivery
The degree of obesity was determined according to the classification of body mass index of the world health organization
In the operating room patients were monitored with pulse oximetry non invasive blood pressure and 3-lead electrocardiogram Intravenous access was established Randomization was revealed at this time
Eligible operators for the study were anesthesia fellows and residents in their third and fourth year of training anesthesia Fellows and residents received didactic teaching in the form of reading material and educational video on spinal sonography before patient recruitment and were instructed on how to perform a standardized spinal ultrasound assessment for neuraxial procedures The training proceeded with a demonstration on a live model with typical sonoanatomy at all lumbar spaces and were required to perform the following tasks
1 identification of the sacrum and five lumbar intervertebral spaces in the paramedian sagittal oblique plane
2 determination of the midline and the interspace at different lumbar interspaces the optimal needle insertion point and the distance from the skin to the inner aspect of the ligamentum flavum and dura mater unit in the transverse median plane
A portable ultrasound system sonosite equipped with a curved array probe was utilized
In the standard group with the parturient in a sitting position the anaesthesiologist identified the L4-L5 space using the standard palpation method the imaginary line connecting both upper iliac crests crossing the spine identified the L4-L5 interspace The duration required to identify the point of puncture is noted
In the ultrasound group a preprocedural spinal ultrasound was performed in a non sterile manner with a sitting position Ultrasound visualization in both paramedian and
transverse planes was performed The convex transducer was first placed on the sacral region on a longitudinal paramedian presentation 2-3cm from the midline angled to the spinal canal which leads to the identification of the sacrum as a continuous hyperechoic line Then the transducer was moved in a cephalad direction to identify the intervertebral spaces as acoustic windows and spinous processes as acoustic shadows We draw a transverse line with a disposable skin marker at either the L3-4 or L4-5 interspace Then we rotate the probe 90 degrees and place transversely to determine the midline which was marked by a longitudinal line The intersection of the longitudinal and transverse lines is the point of needle insertion We tilt the probe slightly up and down to ensure a sufficient echogenic window at the selected intervertebral level The distance from the skin to the dura mater is noted
The time required to identify the insertion site is noted
In both groups we record the procedure time which is time from the handle of the spinal needle to observe free flow of cerebrospinal fluid
After a full aseptic painting spinal anesthesia was administered using a 25-gauge 90-mm pencil-point needle inserted through a 20-gauge introducer needle with hyperbaric bupivacaine 25 μg sufentanil and preservative-free morphine 100μg
The dose of bupivacaine will be selected based on the height of the parturient as shown in the table below table1
The patient was positioned supine with left uterine displacement then surgery was allowed to proceed once bilateral sensory block to cold spray to T4 was achieved
Outcome measures
primary outcome
-First pass success rate without needle redirection or reinsertion
Secondary outcomes
1 Number of puncture attempts new skin puncture at the same or different interspace
2 Number of intervertebral interspaces attempted
3 Requirement of needle redirection any withdrawal and re-advancement of the spinal needle andor introducer within an intervertebral space
4 Procedure Time total time required for the identification time from first placement of the introducer until free flow of cerebrospinal fluid
5 Patient satisfaction score
6 Possible complications
Traumatic procedure
Postdural puncture headache
Development of back pain post spinal anesthesia
paresthesia
Ethical Considerations
All patients were included after obtaining their informed consent Appendix
Participation was voluntary and anonymous
We explained to the participants
The usefulness of this study
Absence of significant adverse effects at this dose low dose
The possibility of accepting or refusing participation
The possibility of leaving the study at any time
Ethical approval was provided by our Institutional Hospital Ethics Committee
Written informed consent was obtained from all the participants
Study population
1 Inclusion criteria
Age 18 years old
Normal singleton pregnancy
Gestational age 37 weeks
BMI 30 Kg m2 weight measured on the day before delivery
Planned cesarean section
ASA 2-3
2 Non-inclusion criteria
Patient refusal to participate or unable to provide consent
Emergency cesarean section
patient pregnant with twins
Contraindications to spinal anesthesia
Localized sepsis infection at the puncture site
allergy to any of the drugs planned fo administration
raised intracranial pressure
spine surgery
aortic stenosis
Coagulopathy
hypovolemia
3 Exclusion criteria
Spinal anesthesia failure
Poorly Tolerated spinal anesthesia
Methods
All eligible participants scheduled for cesarean delivery were prospectively randomized to 2 groups using computer-generated random numbers
A standard manual palpation group standard group n45 and a pre-puncture ultrasound-guided neuraxial anesthesia group ultrasound group n45
The sample size calculation was based on a previous study 1 the first-attempt success rate was 52 in the conventional approach and 87 in the ultrasound group
With an α error of 5 and a ß error of 20 80 power a sample size of 43 patients per group was required We increased the number to 45 per group to allow dropouts
The weight height and BMI of the parturients were measured one day before the delivery
The degree of obesity was determined according to the classification of body mass index of the world health organization
In the operating room patients were monitored with pulse oximetry non invasive blood pressure and 3-lead electrocardiogram Intravenous access was established Randomization was revealed at this time
Eligible operators for the study were anesthesia fellows and residents in their third and fourth year of training anesthesia Fellows and residents received didactic teaching in the form of reading material and educational video on spinal sonography before patient recruitment and were instructed on how to perform a standardized spinal ultrasound assessment for neuraxial procedures The training proceeded with a demonstration on a live model with typical sonoanatomy at all lumbar spaces and were required to perform the following tasks
1 identification of the sacrum and five lumbar intervertebral spaces in the paramedian sagittal oblique plane
2 determination of the midline and the interspace at different lumbar interspaces the optimal needle insertion point and the distance from the skin to the inner aspect of the ligamentum flavum and dura mater unit in the transverse median plane
A portable ultrasound system sonosite equipped with a curved array probe was utilized
In the standard group with the parturient in a sitting position the anaesthesiologist identified the L4-L5 space using the standard palpation method the imaginary line connecting both upper iliac crests crossing the spine identified the L4-L5 interspace The duration required to identify the point of puncture is noted
In the ultrasound group a preprocedural spinal ultrasound was performed in a non sterile manner with a sitting position Ultrasound visualization in both paramedian and
transverse planes was performed The convex transducer was first placed on the sacral region on a longitudinal paramedian presentation 2-3cm from the midline angled to the spinal canal which leads to the identification of the sacrum as a continuous hyperechoic line Then the transducer was moved in a cephalad direction to identify the intervertebral spaces as acoustic windows and spinous processes as acoustic shadows We draw a transverse line with a disposable skin marker at either the L3-4 or L4-5 interspace Then we rotate the probe 90 degrees and place transversely to determine the midline which was marked by a longitudinal line The intersection of the longitudinal and transverse lines is the point of needle insertion We tilt the probe slightly up and down to ensure a sufficient echogenic window at the selected intervertebral level The distance from the skin to the dura mater is noted
The time required to identify the insertion site is noted
In both groups we record the procedure time which is time from the handle of the spinal needle to observe free flow of cerebrospinal fluid
After a full aseptic painting spinal anesthesia was administered using a 25-gauge 90-mm pencil-point needle inserted through a 20-gauge introducer needle with hyperbaric bupivacaine 25 μg sufentanil and preservative-free morphine 100μg
The dose of bupivacaine will be selected based on the height of the parturient as shown in the table below table1
The patient was positioned supine with left uterine displacement then surgery was allowed to proceed once bilateral sensory block to cold spray to T4 was achieved
Outcome measures
primary outcome
-First pass success rate without needle redirection or reinsertion
Secondary outcomes
1 Number of puncture attempts new skin puncture at the same or different interspace
2 Number of intervertebral interspaces attempted
3 Requirement of needle redirection any withdrawal and re-advancement of the spinal needle andor introducer within an intervertebral space
4 Procedure Time total time required for the identification time from first placement of the introducer until free flow of cerebrospinal fluid
5 Patient satisfaction score
6 Possible complications
Traumatic procedure
Postdural puncture headache
Development of back pain post spinal anesthesia
paresthesia
Ethical Considerations
All patients were included after obtaining their informed consent Appendix
Participation was voluntary and anonymous
We explained to the participants
The usefulness of this study
Absence of significant adverse effects at this dose low dose
The possibility of accepting or refusing participation
The possibility of leaving the study at any time
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