Brain AneurysmNCT04439760
Superior Cervical Ganglion Block, Transcranial Doppler
A study testing Superior Cervical Ganglion Block in people with Brain Aneurysm and Aneurysm, Ruptured, run by Fatma Ibrahim El Sayed Salman at 1 site in Egypt.
Trial summary
The aim of this study is to assess blood flow velocity in middle cerebral artery measured by transcranial doppler to determine the efficacy of SCG block in decreasing incidence or severity of vasospasm after MCA aneurysm surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Brain Aneurysm, Aneurysm, Ruptured
- What is being tested?
- Superior Cervical Ganglion Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 1 Jul 2022
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged from 18 to 70 years.
- Genders eligible for study: both sexes.
- ASA I-II.
- GCS (13-15)
Who cannot join
- Patient refusal
- Contraindications to regional anesthesia (Bleeding disorders, Use of any anti-coagulants, local infection).
- Known allergy to local anesthetics.
- ASA III-IV.
- Patients aged less than 18 or more than 70.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Superior Cervical Ganglion (SCG) Block on the Incidence and Severity of Vasospasm After Middle Cerebral Artery (MCA)Aneurysmal Surgery Using Transcranial Doppler(TCD). A Randomized Controlled Trial.
The aim of this study is to assess blood flow velocity in middle cerebral artery measured by transcranial doppler to determine the efficacy of SCG block in decreasing incidence or severity of vasospasm after MCA aneurysm surgery.
Read the detailed description
Sympathetic innervation to the face and head is by superior cervical ganglion(SCG), which is the most cranial part of the sympathetic chain. It is suited in a plication of the prevertebral fascia anterior to the longuscapitis muscle and dorsal to the internal carotid artery, posteromedial to the vagus nerve at c3 level. It's mainly located at the level of the transverse processes of the second and third cervical vertebrae. However, it may reach caudally to the upper border of the fourth cervical vertebra.
Noradrenergic sympathetic nerve fibers mainly originating in the superior cervical ganglion, accompanying the carotid artery supply cerebral vasculature particularly the pial vessels.
Superior cervical ganglion block was previously tried in managing neuropathic pain, neuropathic pain in head and face region was investigated in patients using ganglionic local opioid analgesia (GLOA) at the superior cervical ganglion (SCG) ,The short-term analgesic effect of the first blockade by GLOA was significant with a mean pain reduction of 52% (p < 0.001).
Superior cervical ganglion block also used as an alternative treatment to tinnitus not responding to conventional therapy, it increases cholear blood flow and this can explain the efficacy of block.
Superior cervical ganglion block was used to improve cerebral perfusion in patients with cerebral vasospasm after aSAH.
Aneurysmal subarachnoid hemorrhage (aSAH) may develop vasospasm in 70% of patients. Morphological changes occur in the cerebral vessels after SAH, and the inflammatory response and local chemical agents are responsible for the induction of vasospasm.
Vasospasm is rare in the first 3 days after SAH, it reaches peak incidence at 7 to10 days and usually resolves by 10 to14 days after SAH.
The sympathetic system also has a role in the pathogenesis of this process, cervical sympathetic stimulation leads to constriction in intracerebral vessels and dilation occurs when these fibers are interrupted. Efflux and reuptake of the neurotransmitter may be prevented by sympathectomy.
Common treatments to reduce vasospasm include ;triple H therapy (hypertension ,hypervolemia and hemodilution), intraarterial infusion of Smooth muscle relaxants (papaverine, Verapamil) and endovascular balloon angioplasty . Also (nimodipine) calcium channel blocker administration is used as a prophylactic measures.
Transcranial doppler (TCD) is a non-invasive technique which can be used to observe velocity, direction and properties of blood flow in the cerebral arteries by means of a pulsed ultrasonic beam, based on the Doppler effect of ultrasounds concerning frequency variations in sound waves as a result of relative motion between source and signal receiver. It was previously used in traumatic brain injury(TBI),stroke, anesthesia and intensive care.
- Conditions
- Brain Aneurysm, Aneurysm, Ruptured
- Being tested
- Superior Cervical Ganglion Block
- Keywords
- middle cerebral artery
- Medical subject headings
- Intracranial Aneurysm, Aneurysm, Ruptured
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superior Cervical Ganglion BlockProcedure or surgery
Under X-ray guidance, a 23-gauge radiofrequency top-pole needle with an active tip of 5 mm is inserted for test blockade. The needle is directed at the facet joint of the 3rd and 4th cervical vertebrae.The needle is introduced parallel to the radiographic projection and is projected as a dot approximately 1 cm anterior to the spine. The radiographic projection is then changed to lateral, and the needle is slowly advanced until the tip was situated at the anterior border of the third cervical vertebra. On the anteroposterior projection, the tip of the needle is projected over the lateral part of the facetal column. When the tip of the needle is in position, 0.3 mL of Omnipaque is injected. On the transverse projection, the contrast is distinctly anterior to anterior border of the vertebral bodies, and in the anteroposterior projection, the contrast is seen spreading in a space overlying the facetal column in a cranial as well as caudal direction.
| Study group | Role | What they receive |
|---|---|---|
| control study. | No intervention | No intervention |
| superior cervical block. | Active comparator | Under X-ray guidance, a 23-gauge radiofrequency top-pole needle with an active tip of 5 mm is inserted for test blockade. The needle is directed at the facet joint of the 3rd and 4th cervical vertebrae.The needle is introduced parallel to the radiographic projection and is projected as a dot approximately 1 cm anterior to the spine. The radiographic projection is then changed to lateral, and the needle is slowly advanced until the tip was situated at the anterior border of the third cervical vertebra. On the anteroposterior projection, the tip of the needle is projected over the lateral part of the facetal column. When the tip of the needle is in position, 0.3 mL of Omnipaque is injected. On the transverse projection, the contrast is distinctly anterior to anterior border of the vertebral bodies, and in the anteroposterior projection, the contrast is seen spreading in a space overlying the facetal column in a cranial as well as caudal direction. Receives: Procedure: Superior Cervical Ganglion Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Blood flow velocity in middle cerebral artery measured by transcranial doppler (TCD)
Change in Blood flow velocity in patients with ruptured aneurysmal subarachnoid hemorrhage undergoing MCA aneurysmal surgeries measured by transcranial doppler
Measured: The day before surgery (TCD0), Postoperative at day 3 and day 7 (TCD3 & TCD7)
Secondary outcomes (6)
Incidence or severity of MCA postoperative spasm over 14 days.
TCD MCA vasospasm diagnostic criteria :
Proximal MCA vasospasm can be diagnosed by any of the following:
MCA Mean flow velocities of > 200 cm/s, Rapid rise in flow velocities (> 65 cm/s in one day), or Lindegaard ratio (VMCA/VICA >6).
Measured: within 14 days
Change from baseline heart rate
Heart rate will be measured
Measured: Baseline (Before surgery) ,after induction the block and at the end of surgery
Change from baseline mean arterial blood pressure
Mean arterial blood pressure will be measured
Measured: Baseline (Before surgery) ,after induction the block and at the end of surgery
Change from baseline oxygen saturation (Sao2)
Oxygen saturation (Sao2) will be measured
Measured: Baseline (Before surgery) ,after induction the block and at the end of surgery
Incidence of complications (Nerve injury, Hematoma formation, LA toxicity, Sensory or motor deficit, respiratory depression).
Incidence of complications (Nerve injury, Hematoma formation, LA toxicity, Sensory or motor deficit, respiratory depression) will be assisted
Measured: within 14 days
Glasgow coma scale
Glasgow coma scale will be calculated
Measured: Baseline (Preopetative), at day 3 and day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start1 Oct 2020
- Primary completion1 May 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Brain AneurysmStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatma Ibrahim El Sayed Salman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fatma Ibrahim El Sayed Salman, Kasr El Aini Hospital
- Investigators
- Fatma Salman, Master, Principal investigator, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04439760
- Sponsor's protocol ID
- transcranial Doppler
- Status last verified
- Jul 2022
- First submitted
- 13 Jun 2020
- Last updated
- 26 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Siegenthaler A, Haug M, Eichenberger U, Suter MR, Moriggl B. Block of the superior cervical ganglion, description of a novel ultrasound-guided technique in human cadavers. Pain Med. 2013 May;14(5):646-9. doi: 10.1111/pme.12061. Epub 2013 Feb 25.
PubMed 23438374Tuor UI. Local distribution of the effects of sympathetic stimulation on cerebral blood flow in the rat. Brain Res. 1990 Oct 8;529(1-2):224-31. doi: 10.1016/0006-8993(90)90831-u.
PubMed 2282493Kurth CD, Wagerle LC, Delivoria-Papadopoulos M. Sympathetic regulation of cerebral blood flow during seizures in newborn lambs. Am J Physiol. 1988 Sep;255(3 Pt 2):H563-8. doi: 10.1152/ajpheart.1988.255.3.H563.
PubMed 3137827Koning HM, Dyrbye BA, van Hemert FJ. Percutaneous Radiofrequency Lesion of the Superior Cervical Sympathetic Ganglion in Patients with Tinnitus. Pain Pract. 2016 Nov;16(8):994-1000. doi: 10.1111/papr.12348. Epub 2015 Aug 27.
PubMed 26311111Rumalla K, Smith KA, Arnold PM, Mittal MK. Subarachnoid Hemorrhage and Readmissions: National Rates, Causes, Risk Factors, and Outcomes in 16,001 Hospitalized Patients. World Neurosurg. 2018 Feb;110:e100-e111. doi: 10.1016/j.wneu.2017.10.089. Epub 2017 Oct 26.
PubMed 29107164Sharma AK, Bathala L, Batra A, Mehndiratta MM, Sharma VK. Transcranial Doppler: Techniques and advanced applications: Part 2. Ann Indian Acad Neurol. 2016 Jan-Mar;19(1):102-7. doi: 10.4103/0972-2327.173407.
PubMed 27011639
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Superior Cervical Ganglion (SCG) Block on the Incidence and Severity of Vasospasm After Middle Cerebral Artery (MCA)Aneurysmal Surgery Using Transcranial Doppler(TCD). A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04439760
- Acronym / sponsor ID
- transcranial Doppler
- Conditions
- Brain Aneurysm, Aneurysm, Ruptured
- Keywords
- middle cerebral artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Fatma Ibrahim El Sayed SalmanUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 19 Jun 2020 (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.
The aim of this study is to assess blood flow velocity in middle cerebral artery measured by transcranial doppler to determine the efficacy of SCG block in decreasing incidence or severity of vasospasm after MCA aneurysm surgery.
Detailed description
Sympathetic innervation to the face and head is by superior cervical ganglion(SCG), which is the most cranial part of the sympathetic chain. It is suited in a plication of the prevertebral fascia anterior to the longuscapitis muscle and dorsal to the internal carotid artery, posteromedial to the vagus nerve at c3 level. It's mainly located at the level of the transverse processes of the second and third cervical vertebrae. However, it may reach caudally to the upper border of the fourth cervical vertebra.
Noradrenergic sympathetic nerve fibers mainly originating in the superior cervical ganglion, accompanying the carotid artery supply cerebral vasculature particularly the pial vessels.
Superior cervical ganglion block was previously tried in managing neuropathic pain, neuropathic pain in head and face region was investigated in patients using ganglionic local opioid analgesia (GLOA) at the superior cervical ganglion (SCG) ,The short-term analgesic effect of the first blockade by GLOA was significant with a mean pain reduction of 52% (p < 0.001).
Superior cervical ganglion block also used as an alternative treatment to tinnitus not responding to conventional therapy, it increases cholear blood flow and this can explain the efficacy of block.
Superior cervical ganglion block was used to improve cerebral perfusion in patients with cerebral vasospasm after aSAH.
Aneurysmal subarachnoid hemorrhage (aSAH) may develop vasospasm in 70% of patients. Morphological changes occur in the cerebral vessels after SAH, and the inflammatory response and local chemical agents are responsible for the induction of vasospasm.
Vasospasm is rare in the first 3 days after SAH, it reaches peak incidence at 7 to10 days and usually resolves by 10 to14 days after SAH.
The sympathetic system also has a role in the pathogenesis of this process, cervical sympathetic stimulation leads to constriction in intracerebral vessels and dilation occurs when these fibers are interrupted. Efflux and reuptake of the neurotransmitter may be prevented by sympathectomy.
Common treatments to reduce vasospasm include ;triple H therapy (hypertension ,hypervolemia and hemodilution), intraarterial infusion of Smooth muscle relaxants (papaverine, Verapamil) and endovascular balloon angioplasty . Also (nimodipine) calcium channel blocker administration is used as a prophylactic measures.
Transcranial doppler (TCD) is a non-invasive technique which can be used to observe velocity, direction and properties of blood flow in the cerebral arteries by means of a pulsed ultrasonic beam, based on the Doppler effect of ultrasounds concerning frequency variations in sound waves as a result of relative motion between source and signal receiver. It was previously used in traumatic brain injury(TBI),stroke, anesthesia and intensive care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control study. | No intervention | –No intervention |
| superior cervical block. | Active comparator | Procedure: Superior Cervical Ganglion BlockUnder X-ray guidance, a 23-gauge radiofrequency top-pole needle with an active tip of 5 mm is inserted for test blockade. The needle is directed at the facet joint of the 3rd and 4th cervical vertebrae.The needle is introduced parallel to the radiographic projection and is projected as a dot approximately 1 cm anterior to the spine. The radiographic projection is then changed to lateral, and the needle is slowly advanced until the tip was situated at the anterior border of the third cervical vertebra. On the anteroposterior projection, the tip of the needle is projected over the lateral part of the facetal column. When the tip of the needle is in position, 0.3 mL of Omnipaque is injected. On the transverse projection, the contrast is distinctly anterior to anterior border of the vertebral bodies, and in the anteroposterior projection, the contrast is seen spreading in a space overlying the facetal column in a cranial as well as caudal direction. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged from 18 to 70 years.
- Genders eligible for study: both sexes.
- ASA I-II.
- GCS (13-15)
Key exclusion criteria (5 listed)
- Patient refusal
- Contraindications to regional anesthesia (Bleeding disorders, Use of any anti-coagulants, local infection).
- Known allergy to local anesthetics.
- ASA III-IV.
- Patients aged less than 18 or more than 70.
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 |
|---|---|---|
| Superior Cervical Ganglion BlockUnder X-ray guidance, a 23-gauge radiofrequency top-pole needle with an active tip of 5 mm is inserted for test blockade. The needle is directed at the facet joint of the 3rd and 4th cervical vertebrae.The needle is introduced parallel to the radiographic projection and is projected as a dot approximately 1 cm anterior to the spine. The radiographic projection is then changed to lateral, and the needle is slowly advanced until the tip was situated at the anterior border of the third cervical vertebra. On the anteroposterior projection, the tip of the needle is projected over the lateral part of the facetal column. When the tip of the needle is in position, 0.3 mL of Omnipaque is injected. On the transverse projection, the contrast is distinctly anterior to anterior border of the vertebral bodies, and in the anteroposterior projection, the contrast is seen spreading in a space overlying the facetal column in a cranial as well as caudal direction. | Procedure or surgery | superior cervical block. |
Primary outcome
Change from baseline Blood flow velocity in middle cerebral artery measured by transcranial doppler (TCD)
Time frame: The day before surgery (TCD0), Postoperative at day 3 and day 7 (TCD3 & TCD7)
Change in Blood flow velocity in patients with ruptured aneurysmal subarachnoid hemorrhage undergoing MCA aneurysmal surgeries measured by transcranial doppler
6 secondary outcomes
Incidence or severity of MCA postoperative spasm over 14 days.
Time frame: within 14 days
Change from baseline heart rate
Time frame: Baseline (Before surgery) ,after induction the block and at the end of surgery
Change from baseline mean arterial blood pressure
Time frame: Baseline (Before surgery) ,after induction the block and at the end of surgery
Change from baseline oxygen saturation (Sao2)
Time frame: Baseline (Before surgery) ,after induction the block and at the end of surgery
Incidence of complications (Nerve injury, Hematoma formation, LA toxicity, Sensory or motor deficit, respiratory depression).
Time frame: within 14 days
Glasgow coma scale
Time frame: Baseline (Preopetative), at day 3 and day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Background: PubMed 23438374Siegenthaler A, Haug M, Eichenberger U, Suter MR, Moriggl B. Block of the superior cervical ganglion, description of a novel ultrasound-guided technique in human cadavers. Pain Med. 2013 May;14(5):646-9. doi: 10.1111/pme.12061. Epub 2013 Feb 25.
- Background: PubMed 2282493Tuor UI. Local distribution of the effects of sympathetic stimulation on cerebral blood flow in the rat. Brain Res. 1990 Oct 8;529(1-2):224-31. doi: 10.1016/0006-8993(90)90831-u.
- Background: PubMed 3137827Kurth CD, Wagerle LC, Delivoria-Papadopoulos M. Sympathetic regulation of cerebral blood flow during seizures in newborn lambs. Am J Physiol. 1988 Sep;255(3 Pt 2):H563-8. doi: 10.1152/ajpheart.1988.255.3.H563.
- Background: PubMed 26311111Koning HM, Dyrbye BA, van Hemert FJ. Percutaneous Radiofrequency Lesion of the Superior Cervical Sympathetic Ganglion in Patients with Tinnitus. Pain Pract. 2016 Nov;16(8):994-1000. doi: 10.1111/papr.12348. Epub 2015 Aug 27.
- Background: PubMed 29107164Rumalla K, Smith KA, Arnold PM, Mittal MK. Subarachnoid Hemorrhage and Readmissions: National Rates, Causes, Risk Factors, and Outcomes in 16,001 Hospitalized Patients. World Neurosurg. 2018 Feb;110:e100-e111. doi: 10.1016/j.wneu.2017.10.089. Epub 2017 Oct 26.
- Background: PubMed 27011639Sharma AK, Bathala L, Batra A, Mehndiratta MM, Sharma VK. Transcranial Doppler: Techniques and advanced applications: Part 2. Ann Indian Acad Neurol. 2016 Jan-Mar;19(1):102-7. doi: 10.4103/0972-2327.173407.
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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.
Fatma Salman, Master principal investigator
Kasr El Aini Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Superior Cervical Ganglion Block in people with Brain Aneurysm and Aneurysm, Ruptured, run by Fatma Ibrahim El Sayed Salman at 1 site in Egypt.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 26 Jul 2022. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Blood flow velocity in middle cerebral artery measured by transcranial doppler (TCD) (time frame: The day before surgery (TCD0), Postoperative at day 3 and day 7 (TCD3 & TCD7)). 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 NCT04439760, which also lists 6 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 26 Jul 2022.