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Completed

NCT Number: NCT04439760

Superior Cervical Ganglion Block, Transcranial Doppler

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

kasr Al Ainy hospital

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Superior Cervical Ganglion Block

Procedure

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 outcomes

  1. 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

Secondary outcomes

  1. Incidence or severity of MCA postoperative spasm over 14 days.

    Time frame: within 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).

  2. Change from baseline heart rate

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

    Heart rate will be measured

  3. Change from baseline mean arterial blood pressure

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

    Mean arterial blood pressure will be measured

  4. Change from baseline oxygen saturation (Sao2)

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

    Oxygen saturation (Sao2) will be measured

  5. Incidence of complications (Nerve injury, Hematoma formation, LA toxicity, Sensory or motor deficit, respiratory depression).

    Time frame: within 14 days

    Incidence of complications (Nerve injury, Hematoma formation, LA toxicity, Sensory or motor deficit, respiratory depression) will be assisted

  6. Glasgow coma scale

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

    Glasgow coma scale will be calculated

Sponsors and collaborators

Lead sponsor

Fatma Ibrahim El Sayed Salman

Other

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 19, 2020
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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