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CompletedNCT04439760Updated Jul 26, 2022

Superior Cervical Ganglion Block, Transcranial Doppler

An interventional study of Superior Cervical Ganglion Block in Brain Aneurysm and Aneurysm, Ruptured, sponsored by Fatma Ibrahim El Sayed Salman. Completed at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-07-26.

Sponsored by Fatma Ibrahim El Sayed Salman · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Brain Aneurysm
  • Aneurysm, Ruptured

Keywords

  • middle cerebral artery
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • No intervention
    control study.

    No intervention

  • Active comparator
    superior cervical 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.

    Procedure: Superior Cervical Ganglion Block

Interventions

  • ProcedureSuperior 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.

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: The day before surgery (TCD0), Postoperative at day 3 and day 7 (TCD3 & TCD7)

Secondary outcomes

  1. 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).

    Time frame: within 14 days

  2. Change from baseline heart rate

    Heart rate will be measured

    Time frame: Baseline (Before surgery) ,after induction the block and at the end of surgery

  3. Change from baseline mean arterial blood pressure

    Mean arterial blood pressure will be measured

    Time frame: Baseline (Before surgery) ,after induction the block and at the end of surgery

  4. Change from baseline oxygen saturation (Sao2)

    Oxygen saturation (Sao2) will be measured

    Time frame: Baseline (Before surgery) ,after induction the block and at the end of surgery

  5. 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

    Time frame: within 14 days

  6. Glasgow coma scale

    Glasgow coma scale will be calculated

    Time frame: Baseline (Preopetative), at day 3 and day 7

06

Study locations

1 site
  • kasr Al Ainy hospital
    Cairo, Egypt
07

References and documents

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 23438374 ↗
  • 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. PubMed 2282493 ↗
  • 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. PubMed 3137827 ↗
  • 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. PubMed 26311111 ↗
  • 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. PubMed 29107164 ↗
  • 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. PubMed 27011639 ↗
08

Registry details

Key details

Study ID
NCT04439760
Lead sponsor
Fatma Ibrahim El Sayed Salman
Responsible party
Fatma Ibrahim El Sayed Salman (anesthesia assistant lecturer, Kasr El Aini Hospital) — Sponsor-investigator
First posted
Jun 19, 2020
Start date
Oct 1, 2020
Primary completion
May 1, 2022
Completion
Jul 1, 2022
Last update
Jul 26, 2022

Study contacts

Fatma Salman, Master
principal investigator · Kasr El Aini Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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