search
Back to results

Impact of Interscalene Nerve Block on Cerebral Perfusion During Surgery in the Beachchair Position

Primary Purpose

Cerebral Ischemia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Interscalene nerve block and catheter
Interscalene catheter
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cerebral Ischemia focused on measuring Cerebral ischemia, Beachchair position, Interscalene nerve block

Eligibility Criteria

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

Inclusion Criteria:

  • Scheduled for shoulder surgery in the sitting position
  • Surgery of the shoulder and clavicular area, eligible to an interscalene nerve block
  • American Society of Anesthesiologists (ASA) physical status 1-3

Exclusion Criteria:

  • Carotid artery stenosis
  • History of stroke or other significant central nervous system lesion
  • Inadequate temporal window to perform transcranial Doppler
  • Contraindication to interscalene nerve block
  • Patient refusal

Sites / Locations

  • Centre Hospitalier de l'Université de Montréal (CHUM)

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Interscalene catheter

Interscalene nerve block and catheter

Arm Description

No block will be performed prior to surgery. An interscalene catheter will be inserted under ultrasound guidance by the anesthesiologist before the induction of anesthesia. Local anesthetics will only be administered once all TCD assessments are completed but prior to the end of surgery.

The anesthesiologist will perform the interscalene nerve block and insert an interscalene catheter under ultrasound guidance before induction of anesthesia. A standardized mixture of bupivacaine, lidocaine and epinephrine will be administered prior to surgery.

Outcomes

Primary Outcome Measures

Cerebral blood flow in the median cerebral artery
Cerebral blood flow will be assessed using the transcranial Doppler. Because the bones of the skull block the transmission of ultrasound, region with thinner walls must be used for analyzing. For this reason, recording will be performed in the temporal region above the zygomatic arch.

Secondary Outcome Measures

Arterial blood pressure
Arterial blood pressure will be measured during each TCD.
Body temperature
Body temperature will be recorded at every TCD performed following induction of general anesthesia.
End-tidal carbon dioxide
End-tidal carbon dioxide will be recorded at every TCD performed following induction of general anesthesia.
Minimum alveolar concentration (MAC) of Desflurane
Minimum alveolar concentration of Desflurane will be recorded at every TCD performed following induction of general anesthesia.

Full Information

First Posted
November 7, 2013
Last Updated
October 14, 2015
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
search

1. Study Identification

Unique Protocol Identification Number
NCT01983618
Brief Title
Impact of Interscalene Nerve Block on Cerebral Perfusion During Surgery in the Beachchair Position
Official Title
Impact of Interscalene Nerve Block on Cerebral Perfusion During Surgery in the Beachchair Position Under General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Beachchair position is used by many orthopaedic surgeons for shoulder surgery. Most patients undergoing surgery in this position have no complications. However, reported cases of postoperative neurological deficits have highlighted the risk of cerebral and spinal cord ischemia. The etiology of such complications remains unclear. The most plausible explanation for these events would be intraoperative hypotension followed by cerebral hypoperfusion. General anesthesia is commonly used for shoulder surgery in conjunction with interscalene brachial plexus blockade. During the block, local anesthetic's spread is frequently observed leading to a block of sympathetic fibres. Since all nerves located in the head and neck area go through the stellate ganglion, its block will cause a sympathetic denervation and a decrease of the peripheral vascular resistance, thus increasing the circulation in cerebral blood vessels. In normal situations, there is a vasoconstriction of the cerebral blood vessels in response to a sympathetic stimulation and a vasodilation if sympathetic fibres are blocked. Transcranial Doppler (TCD) is a non-invasive examination that provides a reliable evaluation of intracranial blood flow in real-time. It can help to detect sudden changes in perfusion and identify potential embolic events. Some studies using TCD have shown an increased ipsilateral cerebral blood flow (CBF) secondary to a reduced vascular tone associated with a stellate ganglion block. Others have shown a reduction of contralateral CBF that could theoretically increase the risk of ischemia in the affected area. This study will assess the role of interscalene nerve blockade in the protection of cerebral ischemia and preservation of cerebral autoregulation. This study will also aim to identify changes in contralateral CBF. The investigators hypothesize that: Interscalene nerve block will increase CBF Interscalene nerve block will not decrease contralateral CBF Cerebral autoregulation will be preserved under general anesthesia in conjunction with an interscalene nerve block in this setting.
Detailed Description
Prior to surgery, each patient will undergo a baseline bilateral TCD examination in supine position. If the Doppler's results are satisfactory, the patient will then be randomized and proceed to the next step. In case of inadequate results, the patient's participation to the study will be terminated. The interscalene nerve block and the insertion of the interscalene catheter will be performed according to randomization. In the interscalene nerve block and catheter group, the attending anaesthesiologist will assess the success of the block and record the presence or absence of Horner's syndrome. The transcranial Doppler operator will be blinded to these observations. Following the insertion of the interscalene catheter, the patient will undergo a second bilateral TCD in supine position before induction of anesthesia. The anesthetic technique and monitoring will be standardized. After the induction of anesthesia, a bilateral TCD will be performed with the patient in supine position. Another examination will be performed under general anesthesia immediately after and 30 minutes following the installation of the patient in the beachchair position. A last TCD will be performed after a reduction of end-tidal carbon dioxide at 30 mm Hg. For each examination, the arterial blood pressure must be stabilized for at least 5 minutes before the Doppler can be initiated. Arterial blood pressure will be measured during each examination. Type, duration of surgery and beachchair position will be recorded. Vasopressor therapy will be noted. Body temperature, end-tidal carbon dioxide and minimum alveolar concentration of desflurane will be collected during each examination performed under general anesthesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Ischemia
Keywords
Cerebral ischemia, Beachchair position, Interscalene nerve block

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interscalene catheter
Arm Type
Placebo Comparator
Arm Description
No block will be performed prior to surgery. An interscalene catheter will be inserted under ultrasound guidance by the anesthesiologist before the induction of anesthesia. Local anesthetics will only be administered once all TCD assessments are completed but prior to the end of surgery.
Arm Title
Interscalene nerve block and catheter
Arm Type
Experimental
Arm Description
The anesthesiologist will perform the interscalene nerve block and insert an interscalene catheter under ultrasound guidance before induction of anesthesia. A standardized mixture of bupivacaine, lidocaine and epinephrine will be administered prior to surgery.
Intervention Type
Procedure
Intervention Name(s)
Interscalene nerve block and catheter
Intervention Type
Procedure
Intervention Name(s)
Interscalene catheter
Primary Outcome Measure Information:
Title
Cerebral blood flow in the median cerebral artery
Description
Cerebral blood flow will be assessed using the transcranial Doppler. Because the bones of the skull block the transmission of ultrasound, region with thinner walls must be used for analyzing. For this reason, recording will be performed in the temporal region above the zygomatic arch.
Time Frame
From arrival in the operating theatre until the end of surgery. Patients will be followed for an average of 3 hours.
Secondary Outcome Measure Information:
Title
Arterial blood pressure
Description
Arterial blood pressure will be measured during each TCD.
Time Frame
From arrival in the operating theatre until the end of surgery. Patients will be followed for an average of 3 hours.
Title
Body temperature
Description
Body temperature will be recorded at every TCD performed following induction of general anesthesia.
Time Frame
From induction of anesthesia until the end of surgery. Patients will be followed for an average of 2 hours.
Title
End-tidal carbon dioxide
Description
End-tidal carbon dioxide will be recorded at every TCD performed following induction of general anesthesia.
Time Frame
From induction of anesthesia until the end of surgery. Patients will be followed for an average of 2 hours.
Title
Minimum alveolar concentration (MAC) of Desflurane
Description
Minimum alveolar concentration of Desflurane will be recorded at every TCD performed following induction of general anesthesia.
Time Frame
From induction of anesthesia until the end of surgery. Patients will be followed for an average of 2 hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Scheduled for shoulder surgery in the sitting position Surgery of the shoulder and clavicular area, eligible to an interscalene nerve block American Society of Anesthesiologists (ASA) physical status 1-3 Exclusion Criteria: Carotid artery stenosis History of stroke or other significant central nervous system lesion Inadequate temporal window to perform transcranial Doppler Contraindication to interscalene nerve block Patient refusal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sébastien Garneau, MD, FRCPC
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de l'Université de Montréal (CHUM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Impact of Interscalene Nerve Block on Cerebral Perfusion During Surgery in the Beachchair Position

We'll reach out to this number within 24 hrs