Anesthesia, Spinal, Cesarean Section, Spinal Ultrasound
Conditions
Brief summary
The study will compare between preprocedural ultrasonography and the conventional palpation technique for spinal anesthesia in obese parturients undergoing elective cesarean delivery
Detailed description
This randomized, controlled, double-blind study will be conducted on ASA physical status II-III obese parturients with full-term singleton pregnancy undergoing elective cesarean delivery under spinal anesthesia. The study subjects will be assigned to 2 equal groups. In the ultrasonography group, lumbar spinal ultrasonography will be performed before administration of spinal anesthesia. In the palpation group, conventional palpation of the anatomical landmarks will be performed.
Interventions
RADIATIONLumbar Spinal Ultrasonography
Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the intervertebral space with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 intervertebral spaces.
RADIATIONSham Ultrasound Procedure
Moving the ultrasound probe on the patient's back with the machine in the freeze position.
PROCEDUREConventional Landmark Palpation
Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) is assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest intervertebral space. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 intervertebral spaces.
PROCEDURESpinal Anesthesia
Spinal anesthesia using a 25- or 22-gauge spinal needle
Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space
Fentanyl 15 μg will be administered in the subarachnoid space
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists physical status II-III parturients * Full term singleton pregnancy * Body mass index ≥ 35 Kg/m2
Exclusion criteria
* Age \< 19 years * Women presenting in labor * Contraindications to neuraxial anesthesia (Coagulopathy, increased intracranial pressure, or local skin infection) * Significant spinal deformities or previous spinal surgery * Preeclampsia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Needle Passes Required to Obtain Free Cerebrospinal Fluid Flow | Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes | Needle pass is any forward introduction of the spinal needle after its complete or incomplete withdrawal, including the first attempt. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Needle Pass | Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes | Needle pass is any forward introduction of the spinal needle after its complete or incomplete withdrawal, including the first attempt. |
| Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Skin Puncture | Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes | Skin puncture is any separate skin puncture by the spinal needle after its complete withdrawal, including the first attempt. |
| Duration of the Spinal Procedure | Assessed from enrollment in the study until completion of cesarean delivery | The duration from starting the first skin puncture by the spinal needle to obtaining free CSF flow |
| Patient Satisfaction | Assessed at 1 minute after intrathecal injection | Patient satisfaction from the procedure assessed immediately after intrathecal injection using a 5-point scale (1 = very unsatisfied; 2 = unsatisfied; 3 = fair; 4 = satisfied; and 5 = very satisfied). |
| Number of Skin Punctures Required to Obtain Free Cerebrospinal Fluid Flow | Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes | Skin puncture is any separate skin puncture by the spinal needle after its complete withdrawal, including the first attempt. |
| Number of Participants With Paresthesia | Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes | Number of participants with paresthesia reported by the subjects during performing the spinal procedure |
| Number of Participants With Failure to Obtain Free Cerebrospinal Fluid Flow | Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes | Number of participants with failure to obtain free cerebrospinal fluid flow after adequate needle passes at 6 separate skin punctures. |
| Number of Participants With Failed Spinal Block | Assessed up to 20 minutes after intrathecal injection | Number of participants with failed spinal block defined as an upper sensory level below T6 assessed by pinprick. |
| Number of Participants With Vascular Puncture | Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes | Number of participants with unintentional vascular puncture by the needle during performing the spinal procedure |
Countries
Egypt
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ultrasonography Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.
Lumbar Spinal Ultrasonography: Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the interspace with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.
Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle
Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space
Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space | 140 |
| Palpation Sham ultrasound procedure. Conventional landmark palpation and skin marking. Spinal anesthesia was administered with injection of intrathecal bupivacaine and intrathecal fentanyl.
Sham Ultrasound Procedure: Sliding the ultrasound probe on the patient's back with the machine in the freeze position.
Conventional Landmark Palpation: Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) was assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest interspace. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 interspaces.
Spinal Anesthesia: Spinal anesthesia using a 25- or 22-gauge spinal needle
Intrathecal Bupivacaine: Bupivacaine 12.5 mg (2.5 mL 0.5%) was administered in the subarachnoid space
Intrathecal Fentanyl: Fentanyl 15 μg was administered in the subarachnoid space | 140 |
| Total | 280 |
Baseline characteristics
| Characteristic | Ultrasonography | Palpation | Total |
|---|---|---|---|
| Age, Continuous | 30.2 years STANDARD_DEVIATION 5.9 | 30.3 years STANDARD_DEVIATION 5.5 | 30.3 years STANDARD_DEVIATION 5.7 |
| Body mass index | 40.2 kg/m^2 | 39.2 kg/m^2 | 39.8 kg/m^2 |
| Ease of landmark palpation 1 | 11 Participants | 17 Participants | 28 Participants |
| Ease of landmark palpation 2 | 57 Participants | 62 Participants | 119 Participants |
| Ease of landmark palpation 3 | 63 Participants | 54 Participants | 117 Participants |
| Ease of landmark palpation 4 | 9 Participants | 7 Participants | 16 Participants |
| Gestational age (weeks) | 38 weeks | 38 weeks | 38 weeks |
| Height | 159.5 cm STANDARD_DEVIATION 6.1 | 160 cm STANDARD_DEVIATION 6.1 | 159.7 cm STANDARD_DEVIATION 6.1 |
| Nulliparous | 21 Participants | 19 Participants | 40 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Egypt | 140 participants | 140 participants | 280 participants |
| Sex: Female, Male Female | 140 Participants | 140 Participants | 280 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Weight | 102 kg | 103 kg | 102 kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 140 | 0 / 140 |
| other Total, other adverse events | 0 / 140 | 0 / 140 |
| serious Total, serious adverse events | 0 / 140 | 0 / 140 |
Outcome results
Primary
Number of Needle Passes Required to Obtain Free Cerebrospinal Fluid Flow
Needle pass is any forward introduction of the spinal needle after its complete or incomplete withdrawal, including the first attempt.
Time frame: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ultrasonography | Number of Needle Passes Required to Obtain Free Cerebrospinal Fluid Flow | 3 needle passes |
| Palpation | Number of Needle Passes Required to Obtain Free Cerebrospinal Fluid Flow | 3 needle passes |
p-value: 0.6295% CI: [-0.00005, 1]Wilcoxon (Mann-Whitney)
Secondary
Duration of the Spinal Procedure
The duration from starting the first skin puncture by the spinal needle to obtaining free CSF flow
Time frame: Assessed from enrollment in the study until completion of cesarean delivery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ultrasonography | Duration of the Spinal Procedure | 76 seconds |
| Palpation | Duration of the Spinal Procedure | 59 seconds |
p-value: 0.07795% CI: [-1, 20]Wilcoxon (Mann-Whitney)
Secondary
Number of Participants With Failed Spinal Block
Number of participants with failed spinal block defined as an upper sensory level below T6 assessed by pinprick.
Time frame: Assessed up to 20 minutes after intrathecal injection
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ultrasonography | Number of Participants With Failed Spinal Block | 3 Participants |
| Palpation | Number of Participants With Failed Spinal Block | 4 Participants |
p-value: >0.99Fisher Exact
Secondary
Number of Participants With Failure to Obtain Free Cerebrospinal Fluid Flow
Number of participants with failure to obtain free cerebrospinal fluid flow after adequate needle passes at 6 separate skin punctures.
Time frame: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ultrasonography | Number of Participants With Failure to Obtain Free Cerebrospinal Fluid Flow | 0 Participants |
| Palpation | Number of Participants With Failure to Obtain Free Cerebrospinal Fluid Flow | 0 Participants |
Secondary
Number of Participants With Paresthesia
Number of participants with paresthesia reported by the subjects during performing the spinal procedure
Time frame: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ultrasonography | Number of Participants With Paresthesia | 16 Participants |
| Palpation | Number of Participants With Paresthesia | 17 Participants |
p-value: >0.99Chi-squared, Corrected
Secondary
Number of Participants With Vascular Puncture
Number of participants with unintentional vascular puncture by the needle during performing the spinal procedure
Time frame: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ultrasonography | Number of Participants With Vascular Puncture | 9 Participants |
| Palpation | Number of Participants With Vascular Puncture | 9 Participants |
p-value: >0.99Chi-squared, Corrected
Secondary
Number of Skin Punctures Required to Obtain Free Cerebrospinal Fluid Flow
Skin puncture is any separate skin puncture by the spinal needle after its complete withdrawal, including the first attempt.
Time frame: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ultrasonography | Number of Skin Punctures Required to Obtain Free Cerebrospinal Fluid Flow | 1 skin punctures |
| Palpation | Number of Skin Punctures Required to Obtain Free Cerebrospinal Fluid Flow | 1 skin punctures |
p-value: 0.58Wilcoxon (Mann-Whitney)
Secondary
Patient Satisfaction
Patient satisfaction from the procedure assessed immediately after intrathecal injection using a 5-point scale (1 = very unsatisfied; 2 = unsatisfied; 3 = fair; 4 = satisfied; and 5 = very satisfied).
Time frame: Assessed at 1 minute after intrathecal injection
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ultrasonography | Patient Satisfaction | 5 units on a scale |
| Palpation | Patient Satisfaction | 4 units on a scale |
p-value: 0.195% CI: [-0.00001, 0.00003]Wilcoxon (Mann-Whitney)
Secondary
Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Needle Pass
Needle pass is any forward introduction of the spinal needle after its complete or incomplete withdrawal, including the first attempt.
Time frame: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ultrasonography | Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Needle Pass | 40 Participants |
| Palpation | Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Needle Pass | 45 Participants |
p-value: 0.695% CI: [-0.15, 0.079]Chi-squared, Corrected
Secondary
Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Skin Puncture
Skin puncture is any separate skin puncture by the spinal needle after its complete withdrawal, including the first attempt.
Time frame: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ultrasonography | Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Skin Puncture | 108 Participants |
| Palpation | Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Skin Puncture | 111 Participants |
p-value: 0.7795% CI: [-0.125, 0.082]Chi-squared, Corrected