Conscious sedation vs Axillary or Brachial plexus block in Interventional Radiology (SABIR) for endovascular fistula treatment in adults.

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.