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Trial registered on ANZCTR


Registration number
ACTRN12623000994684
Ethics application status
Approved
Date submitted
19/08/2023
Date registered
12/09/2023
Date last updated
12/09/2023
Date data sharing statement initially provided
12/09/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Conscious sedation vs Axillary or Brachial plexus block in Interventional Radiology (SABIR) for endovascular fistula treatment in adults.
Scientific title
Conscious sedation vs Axillary or Brachial plexus block in Interventional Radiology (SABIR) for endovascular fistuloplasty treatment in adults.
Secondary ID [1] 310422 0
nil
Universal Trial Number (UTN)
Trial acronym
SABIR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adult patients requiring fistoloplasty 331182 0
Procedural sedation 331183 0
Condition category
Condition code
Anaesthesiology 327958 327958 0 0
Pain management

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
SABIR is a prospective observational cohort study. Regardless of study enrollment, participants will receive either conscious intravenous sedation or regional anaesthesia (axillary or brachial plexus block) based on proceduralist expertise, staffing availability and patient factors; these considerations are not contingent on study participation.

Prospective observational (non-randomised) study comparing the efficacy and safety of regional anaesthesia (axillary or brachial plexus block) and conscious intravenous sedation for fistuloplasty procedures in interventional radiology.

Some proceduralists only perform fistuloplasty under sedation while others only perform with regional block. This provides 2 inherent inbuilt treatment arms based on current practice that we aim to compare (observational). In the vast majority of cases, the decision for sedation vs block is made automatically based on proceduralist expertise, staffing availability and patient factors which removes the potential bias in choosing for each case.

Following filtration through the inclusion and exclusion criteria and informed consent, patients will be enrolled into the study. Levels of pain will be recorded and compared between the two groups. Patient and proceduralist satisfaction will also be assessed.

The primary outcome is to assess the efficacy and safety of regional anaesthesia for fistuloplasty in interventional radiology compared to conscious intravenous sedation.
Secondary: to assess proceduralist and patient satisfaction with regional anaesthesia compared to conscious intravenous sedation.

Patients will be anaesthetised with regional (axillary nerve or brachial plexus) block or conscious intravenous sedation (midazolam + fentanyl). They will be closely monitored during the procedure (just prior to and during each intervention) as well as surveyed pre and post procedure to determine levels of pain and satisfaction. Procedure time, adverse symptoms, complications and perception of overall experience will also be recorded for correlation and analysis.

Participants’ enrollment data will include; age, sex, date of birth, medical record number (MRN).
ASA (American Society of Anesthesiologists) anaesthetic risk score, ECOG (Eastern Cooperative Oncology Group) score performance status assessment and cause of end-stage renal failure.

Participants will be assessed through standardised questionnaires pre and post procedure in addition to monitoring levels of analgesia at defined points during the procedure; using a 0-10 scale. A proceduralist questionnaire will also be conducted. The questionnaires/data collection sheets have been attached as appendix 2. The procedure time, any adverse events or complications will also be recorded for correlation and analysis.

If the patient withdraws consent, their data will be removed and excluded from the study, and this will be clearly communicated at the time of consent and outlined in the participants information sheet. Duration of observation is only pertaining to the intervention; ie registration, pre & post-procedure questionnaire (performed one hour post procedure and the proceduralist questionnaire. Data collection will be carried out over 6 months.

Data analysis and retention: Hard copy information will be destroyed once stored electronically and all data will be disposed of at the end of the standard retention period (15 years for clinical trial as stipulated by NSW requirements). All information in publication will not be identified by individual cases.
Intervention code [1] 326817 0
Not applicable
Comparator / control treatment
Comparator group will receive conscious intravenous sedation (midazolam + fentanyl).
We aim to compare (observational). In the vast majority of cases, the decision for sedation vs block is made automatically based on proceduralist expertise, staffing availability and patient factors which removes the potential bias in choosing for each case.

Patients will be anaesthetised with regional (axillary nerve or brachial plexus) block or conscious intravenous sedation (midazolam + fentanyl). They will be closely monitored during the procedure (just prior to and during each intervention) as well as surveyed pre and post procedure to determine levels of pain and satisfaction. Procedure time, adverse symptoms, complications and perception of overall experience will also be recorded for correlation and analysis.
Control group
Active

Outcomes
Primary outcome [1] 335813 0
Patient levels on a scale of 1-10
Timepoint [1] 335813 0
Pain score will be collected before the proccedure (at time of consent), just before commensing the procedure and a various times throught the proccedure guided by interventions completed but the doctor; these will vary between patients.

Additionally, pain scores will be collected at the end of the proccedure and before patient is discharged from the department
Primary outcome [2] 335897 0
Patient satisfaction with care will be assessed by ask patient about their level of satisfaction with care using questionaire specific to this trial. the questions below will be answered useing a scale from 0-10. The questions are as follows; 'based on your experience today, how willing would you be to undergo the procedure again with this form of analgesia or sedation' , 'overall satisfaction with care', 'what is your satisfaction with the procedure and 'satisfaction with pain relief.'
Timepoint [2] 335897 0
Post procedure questionnaires will include assessment of patient experience, willingness to undergo the procedure again with this form of analgesia or sedation, and satisfaction with care. This will be done in roughly 30-60mins after the procedure.
Secondary outcome [1] 425775 0
Procedure duration is recored using medical recores as per the standard of care for all proccedures performed; this will be used to complete data collection.
Timepoint [1] 425775 0
Shortly after the procedure 5-10mins
Secondary outcome [2] 426065 0
Adverse symptoms will be collected from clinical examination, participant self-reported symptoms, and medical records, patient questionnaire including 'did you experience any other unexpected symptoms or side-effects?'
Timepoint [2] 426065 0
Before patient is discharged from the department
Secondary outcome [3] 426342 0
Information regarding complications will be collected prior to patient discharge from the department, additional data will be collected from the patient's electronic medical records. All patients in the study will be closely monitored by appropriately trained proceduralists and nursing staff. Inservices will be conducted where necessary to ensure adequate training for safe monitoring of procedural sedation and education provided on the research project.

Possible complications include:
Over-analgesia:
The patient will be continuously monitored by the proceduralist and nursing staff, in addition to assessment of pain and sedation just prior to and during fistula intervention. If over-analgesia, sedation or other adverse side effects are encountered the study will be aborted to ensure the safety of the patient. Previously, patients have been escalated to procedural sedation which involves opioid and other sedative agents which carry a higher risk of over-sedation and respiratory depression.

Under-analgesia
Patients' pain levels will be monitored regularly throughout the procedure. If at any stage of the study patient reports under-analgesia, more analgesia may be considered within safe therapeutic limits or the procedure may be terminated or another form of analgesia administered immediately where necessary.

Inadvertent nerve or arterial injury
Inadvertent nerve or arterial injury with needle can occur during the administration of analgesia during axillary nerve block. This is mitigated by the use of ultrasound for image guidance when performing axillary block to ensure it is delivered safely and effectively. Furthermore, the needle used is a small 22-gauge needle, minimising the likelihood of serious harm.

Prolonged numbness post procedure
The duration of numbness post regional block depends on the agents with a maximum effect seen as late as 8 hours after the procedure; if this is the case they will be monitored until symptoms resolve. Otherwise patients will be monitored post-procedurally for 1 hour to ensure return of function, and if for discharge home, will be discharged with care.
Timepoint [3] 426342 0
Before patient is discharged from the department
Secondary outcome [4] 426343 0
Proceduralist satisfaction with procedural sedation or regional anesthesia.
Procedural complication or adverse event will be assessd using the Clavien Dindo classification and the following questions 'was the procedure completed in the expected time frame?', 'Was the patient comfortable throughout the procedure?', and 'Was the analgesia effective for the procedure?'
Timepoint [4] 426343 0
Shortly after the procedure 5-10mins.

Eligibility
Key inclusion criteria
Patients undergoing endovascular fistula intervention in interventional radiology at Liverpool Hospital who are over 18 years of age and able to provide valid consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with documented allergy or anaphylaxis to contrast, pregnancy or patients who opt out or refuse enrolment.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Responses will be recorded according to a likert scale (0 to 10) for pain and anxiety prior to the procedure, intra procedurally and post procedure and compared between the two study groups. Mean, median and standard deviations will be calculated from these responses. The 2 sample T-test with 95% confidence interval will be employed from the data collected. The expected variation between the two study groups would be greater than 1.5 to in order to infer a significant difference.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
20/03/2023
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
50
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25410 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 41152 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 314630 0
Self funded/Unfunded
Name [1] 314630 0
Dr Ross Copping
Country [1] 314630 0
Australia
Funding source category [2] 314683 0
Self funded/Unfunded
Name [2] 314683 0
Dr Paul Balamon
Country [2] 314683 0
Australia
Primary sponsor type
Hospital
Name
South Western Sydney Local Health District Human Research Ethics Committee
Address
Liverpool Hospital , Elizabeth Drive, Goulburn St, Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 316653 0
None
Name [1] 316653 0
Address [1] 316653 0
Country [1] 316653 0
Other collaborator category [1] 282801 0
Individual
Name [1] 282801 0
Dr Shady Osman
Address [1] 282801 0
Interventional Radiology Deparment,Liverpool Hospital , Elizabeth Drive, Goulburn St, Liverpool NSW 2170
Country [1] 282801 0
Australia
Other collaborator category [2] 282802 0
Individual
Name [2] 282802 0
Dr Chandra Annabattula
Address [2] 282802 0
Interventional Radiology Deparment,Liverpool Hospital , Elizabeth Drive, Goulburn St, Liverpool NSW 2170
Country [2] 282802 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313652 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 313652 0
Ethics committee country [1] 313652 0
Australia
Date submitted for ethics approval [1] 313652 0
Approval date [1] 313652 0
20/03/2023
Ethics approval number [1] 313652 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128886 0
Dr Ross Copping
Address 128886 0
Interventional Radiology department, Liverpool Hospital. Elizabeth Drive, Goulburn St, Liverpool NSW 2170
Country 128886 0
Australia
Phone 128886 0
+6128738 7056
Fax 128886 0
+61287387062
Email 128886 0
ross.copping@health.nsw.gov.au
Contact person for public queries
Name 128887 0
Ross Copping
Address 128887 0
Interventional Radiology department, Liverpool Hospital. Elizabeth Drive, Goulburn St, Liverpool NSW 2170
Country 128887 0
Australia
Phone 128887 0
+6128738 7056
Fax 128887 0
+61287387062
Email 128887 0
ross.copping@health.nsw.gov.au
Contact person for scientific queries
Name 128888 0
Ross Copping
Address 128888 0
Interventional Radiology department, Liverpool Hospital. Elizabeth Drive, Goulburn St, Liverpool NSW 2170
Country 128888 0
Australia
Phone 128888 0
+6128738 7056
Fax 128888 0
+61287387062
Email 128888 0
ross.copping@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.