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Superior Cervical Ganglion Block, Transcranial Doppler

Primary Purpose

Brain Aneurysm, Aneurysm, Ruptured

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Superior Cervical Ganglion Block
Sponsored by
Fatma Ibrahim El Sayed Salman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Brain Aneurysm focused on measuring middle cerebral artery

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged from 18 to 70 years.
  • Genders eligible for study: both sexes.
  • ASA I-II.
  • GCS (13-15)

Exclusion Criteria:

  • 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.

Sites / Locations

  • kasr Al Ainy hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

control study.

superior cervical block.

Arm Description

No intervention

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
Change from baseline heart rate
Heart rate will be measured
Change from baseline mean arterial blood pressure
Mean arterial blood pressure will be measured
Change from baseline oxygen saturation (Sao2)
Oxygen saturation (Sao2) will be measured
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
Glasgow coma scale
Glasgow coma scale will be calculated

Full Information

First Posted
June 13, 2020
Last Updated
July 25, 2022
Sponsor
Fatma Ibrahim El Sayed Salman
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1. Study Identification

Unique Protocol Identification Number
NCT04439760
Brief Title
Superior Cervical Ganglion Block, Transcranial Doppler
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Fatma Ibrahim El Sayed Salman

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Aneurysm, Aneurysm, Ruptured
Keywords
middle cerebral artery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control study.
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
superior cervical block.
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Superior Cervical Ganglion Block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline Blood flow velocity in middle cerebral artery measured by transcranial doppler (TCD)
Description
Change in Blood flow velocity in patients with ruptured aneurysmal subarachnoid hemorrhage undergoing MCA aneurysmal surgeries measured by transcranial doppler
Time Frame
The day before surgery (TCD0), Postoperative at day 3 and day 7 (TCD3 & TCD7)
Secondary Outcome Measure Information:
Title
Incidence or severity of MCA postoperative spasm over 14 days.
Description
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).
Time Frame
within 14 days
Title
Change from baseline heart rate
Description
Heart rate will be measured
Time Frame
Baseline (Before surgery) ,after induction the block and at the end of surgery
Title
Change from baseline mean arterial blood pressure
Description
Mean arterial blood pressure will be measured
Time Frame
Baseline (Before surgery) ,after induction the block and at the end of surgery
Title
Change from baseline oxygen saturation (Sao2)
Description
Oxygen saturation (Sao2) will be measured
Time Frame
Baseline (Before surgery) ,after induction the block and at the end of surgery
Title
Incidence of complications (Nerve injury, Hematoma formation, LA toxicity, Sensory or motor deficit, respiratory depression).
Description
Incidence of complications (Nerve injury, Hematoma formation, LA toxicity, Sensory or motor deficit, respiratory depression) will be assisted
Time Frame
within 14 days
Title
Glasgow coma scale
Description
Glasgow coma scale will be calculated
Time Frame
Baseline (Preopetative), at day 3 and day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged from 18 to 70 years. Genders eligible for study: both sexes. ASA I-II. GCS (13-15) Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma Salman, Master
Organizational Affiliation
Kasr El Aini Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
kasr Al Ainy hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
23438374
Citation
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.
Results Reference
background
PubMed Identifier
2282493
Citation
Tuor 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.
Results Reference
background
PubMed Identifier
3137827
Citation
Kurth 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.
Results Reference
background
PubMed Identifier
26311111
Citation
Koning 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.
Results Reference
background
PubMed Identifier
29107164
Citation
Rumalla 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.
Results Reference
background
PubMed Identifier
27011639
Citation
Sharma 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.
Results Reference
background

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Superior Cervical Ganglion Block, Transcranial Doppler

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