Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06134583
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-11-11
Brief Title:
Superior Cervical Sympathetic Block Versus Stellate Ganglion Block in Post-traumatic Subarachnoid Hemorrhage
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Effect of Superior Cervical Sympathetic Block Versus Stellate Ganglion Block to Treat Cerebral Vasospasm in Patients With Refractory Post-traumatic Subarachnoid Hemorrhage
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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:
Posttraumatic Subarachnoid hemorrhage SAH is a life-threatening neurological problem with a high mortality rate Delayed cerebral ischemia DCI is the second-leading cause of death and disability in patients suffering from SAH DCI is strongly associated with cerebral arterial vasospasm CAV which reduces cerebral blood flow CBF and causes cerebral infarction
Various treatment modalities have been tried for the prevention and treatment of vasospasm including oral nimodipine and isovolumic hypertension as well as endovascular treatments such as intra-arterial drug infusion and balloon angioplasty A few studies have demonstrated the role of stellate ganglion block SGB in the management of this dreaded complication
Cervical sympathetic block CSB may be an effective therapy but is not routinely performed to treat vasospasmDCI CSB is a local minimally invasive low cost and safe technique that can be performed at the bedside and may offer significant advantages as complementary treatment in combination with more conventional neurointerventional surgery interventions
Aim of study is evaluating the effect of superior sympathetic ganglion block versus stellate ganglion block in treating cerebral vasospasm and prevention of delayed cerebral ischemia in refractory post-traumatic subarachnoid hemorrhage
Various treatment modalities have been tried for the prevention and treatment of vasospasm including oral nimodipine and isovolumic hypertension as well as endovascular treatments such as intra-arterial drug infusion and balloon angioplasty A few studies have demonstrated the role of stellate ganglion block SGB in the management of this dreaded complication
Cervical sympathetic block CSB may be an effective therapy but is not routinely performed to treat vasospasmDCI CSB is a local minimally invasive low cost and safe technique that can be performed at the bedside and may offer significant advantages as complementary treatment in combination with more conventional neurointerventional surgery interventions
Aim of study is evaluating the effect of superior sympathetic ganglion block versus stellate ganglion block in treating cerebral vasospasm and prevention of delayed cerebral ischemia in refractory post-traumatic subarachnoid hemorrhage
Detailed Description:
Trauma patients with CT evidence of post-traumatic SAH will be enrolled in the study and randomly assigned into two groups 30 patients each
1 Group A Superior cervical ganglion block group CSB 5 ml bupivacaine 05 will be injected around the internal carotid artery at the level of carotid bifurcation on the side of spasm and on each side if bilateral spasm using USG
2 Group B Stellate ganglion block group SGB 5 ml bupivacaine 05 will be injected between the common carotid artery and longus capitis muscle at the level of C7 vertebra on the side of spasm and on each side if bilateral spasm using USG
All patients will be treated with a standardized protocol that included immediate intensive care monitoring hypertension MABP 90 mmHg and avoidance of hypotensive events fluid resuscitation to maintain hypervolemia defined as a positive fluid balance 500 mLd and spontaneous hemodilution at 03 hematocrit All patients will receive oral nimodipine for 3 weeks Analgesia as needed and sedation will be avoided if possible
Intervention Technique
1 Superior cervical ganglion block technique
Patients will be placed in the supine position with the head turned to the opposite side of injection
Procedure will be done under complete aseptic technique mastoid process hairline and neck will be disinfected
The common carotid artery will be identified by a high resolution linear ultrasound probe
The probe gradually moved in the cranial direction to the position of the carotid bifurcation
The C2- vertebral transverse process vertebral artery longus capitis muscle LCM and sternocleidomastoid muscle have been located to determine the puncture route
After injection of a local anesthetic to the skin a needle 25-G injection needle will be introduced using the in-plane approach and 5 mL solution of bupivacaine 05 will be injected just behind the internal carotid artery
Monitoring during procedure vital signs blood pressure ECG and SPO2 every 10 minutes up to 30 min after block
Endpoints for procedure success are signs of Horners syndrome will be examined up to 30 min after block
Patients with failed SGB will be excluded
2 Stellate ganglion block technique
Patients will be placed in the supine position with the head turned to the opposite side of injection
Procedure will be done under complete aseptic technique mastoid process hairline and neck will be disinfected
The posterior tubercle of C7 vertebrae vertebral artery will be identified by a high resolution linear ultrasound probe
The probe is moved medially opposite to the level of C7 identifying the common carotid artery 5 ml solution of bupivacaine 05 will be injected between the common carotid and longus colli muscle
The endpoint criterion of SGB success is Horners syndrome which is characterized by miosis ptosis enophthalmos conjunctival hyperemia and facial redness without sweating The patient will be monitored for at least 30 min to rule out any related complications after SGB
Patients with failed SGB will be excluded
3 Basic Transcranial Doppler Exam A low-frequency ultrasound probe is required 2-3 MHz due to improved penetration of ultrasound waves through the cranial temporal bones Both the power M-mode and Doppler mode will be utilized transtemporal window will be used to assess circle of wills arteries
Transtemporal window
1 MCA Depth of 45-65mm with direction toward the probe
2 MCAACA bifurcation Depth of 60-65mm with bidirectional flow
3 ACA Depth of 60-75mm with direction away from the probe
4 PCA P1 Depth of 60-75mm with direction toward the probe
5 PCA P2 Depth of 60-75mm with direction away from the probe
6 Terminal ICA Depth of 60-65mm with direction toward the probe
Parameters extracted from TCD
1 Mean cerebral blood flow velocity Calculated using peak systolic velocity PSV and end-diastolic velocity EDV based on the following formula PSV EDV x 231
2 Resistive index Measure of resistance to blood flow RI PSV - EDVPSV8
3 Lindegaard ratio LR The LR is a calculated value that normalizes the MCA velocity to the ICA This is calculated by the mean velocity of the MCA divided by the mean velocity of the ICA This ratio is important for differentiating hyperemia from true vasospasm on TCD study If the MCA is increased at a higher proportion than the ICA it indicates vasospasm as the source of the elevated velocity A normal LR is considered 3 mild vasospasm 30-45 moderate vasospasm 45-60 and severe vasospasm 60
Pre-interventional Parameters evaluation -
Standard monitoring includes
Hemodynamics ECG Spo2 SBP DBP and MBP every 10 minutes during procedure upto 30 minutes after block
Arterial oxygen saturation
Continuous invasive arterial blood pressure monitoring IABP systolic arterial blood pressures SABP diastolic arterial blood pressure DABP mean arterial blood pressure MABP
Temperature
Preintervention assessment of GCS CBF by TCD assessment of MCA ACA and LR ratio and cerebral blood vessels diameter by MRA whenever possible
Post-interventional data collection -
Duration of study 24 hours after intervention
Hemodynamics HR and MBP every 10 minutes up to 2h after block and then every hour
Postintervention reassessment of CBF by TCD assessment of MCA ACA and LR ratio by the same observer 30 minutes 6 hours 24 hours after block
Cerebral blood vessels diameter by MRA within the first 4 hours after block whenever possible
Any change in GCS within 24h after block
1 Group A Superior cervical ganglion block group CSB 5 ml bupivacaine 05 will be injected around the internal carotid artery at the level of carotid bifurcation on the side of spasm and on each side if bilateral spasm using USG
2 Group B Stellate ganglion block group SGB 5 ml bupivacaine 05 will be injected between the common carotid artery and longus capitis muscle at the level of C7 vertebra on the side of spasm and on each side if bilateral spasm using USG
All patients will be treated with a standardized protocol that included immediate intensive care monitoring hypertension MABP 90 mmHg and avoidance of hypotensive events fluid resuscitation to maintain hypervolemia defined as a positive fluid balance 500 mLd and spontaneous hemodilution at 03 hematocrit All patients will receive oral nimodipine for 3 weeks Analgesia as needed and sedation will be avoided if possible
Intervention Technique
1 Superior cervical ganglion block technique
Patients will be placed in the supine position with the head turned to the opposite side of injection
Procedure will be done under complete aseptic technique mastoid process hairline and neck will be disinfected
The common carotid artery will be identified by a high resolution linear ultrasound probe
The probe gradually moved in the cranial direction to the position of the carotid bifurcation
The C2- vertebral transverse process vertebral artery longus capitis muscle LCM and sternocleidomastoid muscle have been located to determine the puncture route
After injection of a local anesthetic to the skin a needle 25-G injection needle will be introduced using the in-plane approach and 5 mL solution of bupivacaine 05 will be injected just behind the internal carotid artery
Monitoring during procedure vital signs blood pressure ECG and SPO2 every 10 minutes up to 30 min after block
Endpoints for procedure success are signs of Horners syndrome will be examined up to 30 min after block
Patients with failed SGB will be excluded
2 Stellate ganglion block technique
Patients will be placed in the supine position with the head turned to the opposite side of injection
Procedure will be done under complete aseptic technique mastoid process hairline and neck will be disinfected
The posterior tubercle of C7 vertebrae vertebral artery will be identified by a high resolution linear ultrasound probe
The probe is moved medially opposite to the level of C7 identifying the common carotid artery 5 ml solution of bupivacaine 05 will be injected between the common carotid and longus colli muscle
The endpoint criterion of SGB success is Horners syndrome which is characterized by miosis ptosis enophthalmos conjunctival hyperemia and facial redness without sweating The patient will be monitored for at least 30 min to rule out any related complications after SGB
Patients with failed SGB will be excluded
3 Basic Transcranial Doppler Exam A low-frequency ultrasound probe is required 2-3 MHz due to improved penetration of ultrasound waves through the cranial temporal bones Both the power M-mode and Doppler mode will be utilized transtemporal window will be used to assess circle of wills arteries
Transtemporal window
1 MCA Depth of 45-65mm with direction toward the probe
2 MCAACA bifurcation Depth of 60-65mm with bidirectional flow
3 ACA Depth of 60-75mm with direction away from the probe
4 PCA P1 Depth of 60-75mm with direction toward the probe
5 PCA P2 Depth of 60-75mm with direction away from the probe
6 Terminal ICA Depth of 60-65mm with direction toward the probe
Parameters extracted from TCD
1 Mean cerebral blood flow velocity Calculated using peak systolic velocity PSV and end-diastolic velocity EDV based on the following formula PSV EDV x 231
2 Resistive index Measure of resistance to blood flow RI PSV - EDVPSV8
3 Lindegaard ratio LR The LR is a calculated value that normalizes the MCA velocity to the ICA This is calculated by the mean velocity of the MCA divided by the mean velocity of the ICA This ratio is important for differentiating hyperemia from true vasospasm on TCD study If the MCA is increased at a higher proportion than the ICA it indicates vasospasm as the source of the elevated velocity A normal LR is considered 3 mild vasospasm 30-45 moderate vasospasm 45-60 and severe vasospasm 60
Pre-interventional Parameters evaluation -
Standard monitoring includes
Hemodynamics ECG Spo2 SBP DBP and MBP every 10 minutes during procedure upto 30 minutes after block
Arterial oxygen saturation
Continuous invasive arterial blood pressure monitoring IABP systolic arterial blood pressures SABP diastolic arterial blood pressure DABP mean arterial blood pressure MABP
Temperature
Preintervention assessment of GCS CBF by TCD assessment of MCA ACA and LR ratio and cerebral blood vessels diameter by MRA whenever possible
Post-interventional data collection -
Duration of study 24 hours after intervention
Hemodynamics HR and MBP every 10 minutes up to 2h after block and then every hour
Postintervention reassessment of CBF by TCD assessment of MCA ACA and LR ratio by the same observer 30 minutes 6 hours 24 hours after block
Cerebral blood vessels diameter by MRA within the first 4 hours after block whenever possible
Any change in GCS within 24h after block
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