NCT01983618

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:

  1. 1.Interscalene nerve block will increase CBF
  2. 2.Interscalene nerve block will not decrease contralateral CBF
  3. 3.Cerebral autoregulation will be preserved under general anesthesia in conjunction with an interscalene nerve block in this setting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 14, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

October 16, 2015

Status Verified

October 1, 2015

Enrollment Period

1 year

First QC Date

November 7, 2013

Last Update Submit

October 14, 2015

Conditions

Cerebral Ischemia

Keywords

Cerebral ischemiaBeachchair positionInterscalene nerve block

Outcome Measures

Primary Outcomes (1)

  • 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.

    From arrival in the operating theatre until the end of surgery. Patients will be followed for an average of 3 hours.

Secondary Outcomes (4)

  • Arterial blood pressure

    From arrival in the operating theatre until the end of surgery. Patients will be followed for an average of 3 hours.

  • Body temperature

    From induction of anesthesia until the end of surgery. Patients will be followed for an average of 2 hours.

  • End-tidal carbon dioxide

    From induction of anesthesia until the end of surgery. Patients will be followed for an average of 2 hours.

  • Minimum alveolar concentration (MAC) of Desflurane

    From induction of anesthesia until the end of surgery. Patients will be followed for an average of 2 hours.

Study Arms (2)

Interscalene catheter

PLACEBO COMPARATOR

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.

Procedure: Interscalene catheter

Interscalene nerve block and catheter

EXPERIMENTAL

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.

Procedure: Interscalene nerve block and catheter

Interventions

Interscalene nerve block and catheterPROCEDURE
Interscalene nerve block and catheter
Interscalene catheterPROCEDURE
Interscalene catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Conditions

Brain Ischemia

Interventions

Catheters

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Sébastien Garneau, MD, FRCPC

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2013

First Posted

November 14, 2013

Study Start

February 1, 2014

Primary Completion

February 1, 2015

Study Completion

September 1, 2015

Last Updated

October 16, 2015

Record last verified: 2015-10

Locations

CA(1)