Comparison Of The Effects Of Regional Anesthesia On Brain And Carotid Artery Oxygenation In Shoulder Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSanliurfa Mehmet Akif Inan Education and Research Hospital

About this trial

The aim of our study was to compare the effects of interscalene block alone and the combination of interscalene block and superficial cervical block on cerebral oxygenation, carotid artery diameter, intraoperative hemodynamics, laboratory parameters, clinical course and postoperative pain in patients undergoing shoulder surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-65 years patient

American Society of Anesthesiologists (ASA) I-II patient

Disqualifiers

Age < 18 years or > 65 years

History of carotid endarterectomy

History of cerebrovascular accident(CVA)

Body Mass index (BMI)>35 kg/m²

Trial design

Design model

Parallel

Treatments tested in this trial

  • Interscalene brachial plexus block

    Procedure/Surgery

    After sedating the patient with 2 mg midazolam, baseline values will be obtained, and an interscalene block will be performed under ultrasound guidance. Before the block, rSO2 values of both hemispheres of the brain and carotid artery diameter (at T1 and T5 times) will be measured and recorded using a NIRS probe at T2: 5 minute(min), T3: 10 min, T4: 15 min, and T5: 20 min. To assess the quality of the block, the sensory block will be evaluated at 20 minutes. The patient will be placed in a supine position, and after the first rSO2 value is obtained at T6, rSO2 values will be recorded at T7: 10 min, T8: 30 min, T9: 60 min, T10: surgical completion, and T11: 5 min postoperatively in the supine position. Bilateral carotid diameter(mm) will be measured at T6, T10, and T11. Before any postoperative analgesia is administered, the time of the patient's first pain and their need for analgesic will be recorded.

  • Interscalene brachial plexus block and superficial cervical plexus block

    Procedure/Surgery

    After sedating the patient with 2 mg midazolam, baseline values will be obtained, and a combined interscalene and superficial cervical block will be performed under ultrasound guidance. Before the block, rSO2 values of both hemispheres of the brain and carotid artery diameter(mm) (at T1 and T5 times) will be measured and recorded using a NIRS probe at T2: 5 minute, T3: 10 minute, T4: 15 minute, and T5: 20 minute. To assess the quality of the block, the sensory block will be evaluated at 20 minutes. The patient will be placed in a supine position, and after the first rSO2 value is obtained at T6, rSO2 values will be recorded at T7: 10 minute, T8: 30 minute, T9: 60 minute, T10: surgical completion, and T11: 5 minute postoperatively in the supine position. Bilateral carotid diameter(mm) will be measured at T6, T10, and T11. Before any postoperative analgesia is administered, the time of the patient's first pain, and their need for analgesic will be recorded.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: interscalene brachial plexus blockActive comparator 1 intervention
Group B: Combination of superficial cervical plexus block and interscalene brachial plexus block.Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The effect of regional anesthesia on cerebral oxygenation

We plan to investigate the effect of interscalene block or a combination of interscalene and superficial cervical block on oxygenation of both hemispheres of the brain using a NIRS probe.

Time frame
Before block; T1 After block; T2: 5. minute, T3: 10. minute, T4: 15 minute, T5: 20 minute / In the beach chair position; T6: 1. minute, T7: 10. minute, T8: 30. minute, T9: 60. minute, T10: surgical end, Postoperative supine; T11: 5. minute

Secondary outcomes

1

The effect of regional anesthesia on carotid artery diameter

The diameter of the common carotid artery will be measured longitudinally in millimeters(mm) with the transverse probe of the ultrasound at specified times.

Time frame
Before block; T1 After block; T2: 5. minute, T3: 10. minute, T4: 15 minute, T5: 20 minute / In the beach chair position; T6: 1. minute, T7: 10. minute, T8: 30. minute, T9: 60. minute, T10: surgical end, Postoperative supine; T11: 5. minute
2

The effect of the two-block method on the duration of first postoperative analgesia requirement and opioid consumption

The patient will not receive routine analgesia postoperatively. The time(hour) of the first request for analgesia and the amount of opioid consumption within the first 24 postoperative hours will be evaluated.

Time frame
From the end of surgery until the first request for postoperative analgesia and the amount of opioid comsumption, assessed up to 24 hours postoperatively

Other outcomes

1

Effect of block type on saturation

Peripheral oxygen saturation will be measured noninvasively from the finger using pulse oximetry.

Time frame
Before block; T1 After block; T2: 5. minute, T3: 10. minute, T4: 15 minute, T5: 20 minute / In the beach chair position; T6: 1. minute, T7: 10. minute, T8: 30. minute, T9: 60. minute, T10: surgical end, Postoperative supine; T11: 5. minute
2

Effect of block type on blood pressure

Blood pressure will be measured noninvasively from the arm

Time frame
Before block; T1 After block; T2: 5. minute, T3: 10. minute, T4: 15 minute, T5: 20 minute / In the beach chair position; T6: 1. minute, T7: 10. minute, T8: 30. minute, T9: 60. minute, T10: surgical end, Postoperative supine; T11: 5. minute
3

Effect of block type on heart rate

Heart rate will be measured continuously using electrocardiography

Time frame
Before block; T1 After block; T2: 5. minute, T3: 10. minute, T4: 15 minute, T5: 20 minute / In the beach chair position; T6: 1. minute, T7: 10. minute, T8: 30. minute, T9: 60. minute, T10: surgical end, Postoperative supine; T11: 5. minute

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