Superior Cervical Ganglion Block, Transcranial Doppler

Brain Aneurysm Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04439760
• Other study ID #: transcranial Doppler
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: July 2022
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Ruptured
• Brain Aneurysm
• Intracranial Aneurysm

Intervention

Procedure:
• Superior Cervical Ganglion Block
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.

Locations

Country	Name	City	State
Egypt	kasr Al Ainy hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Fatma Ibrahim El Sayed Salman

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The day before surgery (TCD0), Postoperative at day 3 and day 7 (TCD3 & TCD7)
Secondary	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).	within 14 days
Secondary	Change from baseline heart rate	Heart rate will be measured	Baseline (Before surgery) ,after induction the block and at the end of surgery
Secondary	Change from baseline mean arterial blood pressure	Mean arterial blood pressure will be measured	Baseline (Before surgery) ,after induction the block and at the end of surgery
Secondary	Change from baseline oxygen saturation (Sao2)	Oxygen saturation (Sao2) will be measured	Baseline (Before surgery) ,after induction the block and at the end of surgery
Secondary	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	within 14 days
Secondary	Glasgow coma scale	Glasgow coma scale will be calculated	Baseline (Preopetative), at day 3 and day 7