Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202110574604922 Date of Approval: 13/10/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title SUPraclavicular Regional Anaesthesia affecting Bispectral Index™️ as Level Of Consciousness monitor (SUPRABLOC): a Pilot Randomised Controlled trial
Official scientific title The Effect of Supraclavicular Brachial Plexus Blockade on Bispectral Index (BIS) in Adults Undergoing Forearm Surgery: a Pilot Randomised Controlled trial
Brief summary describing the background and objectives of the trial Recent renewed interest in regional anaesthesia during COVID-19 has inspired application of neuraxial anaesthesia for previously unconventional indications, such as awake abdominal surgeries. These patients needed little sedation, since studies demonstrate that neuraxial anaesthesia causes sedation as measured by Bispectral Index (BIS). In contrast, no studies have investigated the possible sedative effects of non-neuraxial regional anaesthesia. This pilot Randomised Controlled Trial (RCT) was designed as template for, and to test the feasibility of performing a definitive RCT to establish if non-neuraxial regional anaesthesia has any sedative effect.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SUPRABLOC
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Effect of non-neuraxial regional anaesthesia, in the form of supraclavicular block, on level of consciousness as measured by Bispectral Index
Anticipated trial start date 01/10/2019
Actual trial start date 03/12/2019
Anticipated date of last follow up 29/02/2020
Actual Last follow-up date 30/07/2020
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Supraclavicular brachial plexus block with 0.5 percent Bupivacaine 2mg/kg of ideal body weight up to maximum of 100mg. Dose administered once pre-operatively. Single dose Forty patients presenting for forearm surgery were randomly allocated to two treatment arms (supraclavicular block and control) after screening and consent. Total of 20 patients received supraclavicular blockade (sterile, ultrasound guided). Their level of sedation was quantitatively monitored prior to surgery for 60 minutes (in induction room) using Bispectral Index monitoring. 20
Control Group Supraclavicular blockade not administered No bupivacaine given N/A Forty patients presenting for forearm surgery were randomly allocated to two treatment arms (supraclavicular block and control) after screening and consent. Total of 20 patients did not receive supraclavicular blockade. Their level of sedation was quantitatively monitored prior to surgery for 60 minutes (in induction room) using Bispectral Index monitoring. 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients presenting for elective and emergency surgery in orthopaedic theatres. Forearm, wrist and hand surgery. American Society of Anesthesiologists (ASA) class 3 or more. Not fasted for 6 hours or more pre-operatively. Known allergies to the local anaesthetics used. Signs of peripheral neuropathy or other neurological disorder affecting the limb to be blocked. Failed block or block complications. Contraindication to peripheral nerve block (including bleeding tendencies). Sedation required in the induction room due to anxiousness or any other reason. Known systemic neurological or psychiatric illnesses or receiving neuroleptic medication. Those who received narcotics, anxiolytics or analgesics is the preceding 8 hours. Baseline oxygen saturation on room air less than 94%. Patients less than 18 or more than 65 years of age. Patients whose oxygen saturation decreased to below 94% or whose blood pressure deviated more than 20% from baseline values after receiving the block Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/10/2019 HREC2 of Stellenbosch University
Ethics Committee Address
Street address City Postal code Country
Stellenbosch University Faculty of Medicine and Health Sciences Francie van Zijl Drive Tygerberg 7505 Cape Town South Africa Cape Town 7505 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 23/06/2021 HREC2 of Stellenbosch University
Ethics Committee Address
Street address City Postal code Country
Stellenbosch University Faculty of Medicine and Health Sciences Francie van Zijl Drive Tygerberg 7505 Cape Town South Africa Cape Town 7505 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary objectives were formulated to test feasibility of performing a larger trial and included assessment of recruitment, acceptance and completion rates, equipment performance, ease of data collection and simplicity of data collection forms and block success rate. Due to the fact that emphasis should not be placed on the statistical significance of intervention effects in pilot trials, the estimated differences between treatment arms and sample size estimates for formal RCT are included in secondary objectives. Primary objectives included a)Assessment of the proportion of patients that can be included after exclusion criteria, b)Assessment of the rate of patient acceptance or refusal to partake in the study, c)Assessment of the proportion of patients who complete the study, d)Investigating the amount of BIS electrodes that need replacing during the study, e)Assessing the quality of BIS recordings by investigating the proportion of inadequate contact of the adhesive causing non-reading BIS values, f)To assess the ease of completing the data form and ease of data collection as determined by the opinion of the person completing this form and g)To assess the rate of supraclavicular block success. A Priori cut-off values for progression to formal RCT were established as follows, a)The proportion of patients that can be asked to participate in the study after initial screening should ideally be = 50% of patients screened, b)Rate of acceptance to participate in the study should be = 50% of patients approached, c)Study should be completed by = 80% of patients, d)Amount of BIS electrodes that need replacing should be = 15% of total number used, e)Less than 10% total inadequate contact as shown by individual BIS contact drop = 15, f)Opinion of ease of completing the data form = 3 on a scale of 1 to 5 (1= Very difficult, 2= Slightly difficult, 3=Normal difficulty, 4=Relatively easy, 5=Easy), g)Block success rate, as judged by inability to completely flex elbow = 90%. All primary outcomes were assess after completion of data collection, that is after July 2020
Secondary Outcome Due to the fact that emphasis should not be placed on the statistical significance of intervention effects in pilot trials, the estimated differences between treatment arms and sample size estimates for formal RCT are included in secondary objectives. Secondary objectives included a)To measure the proportion of patients with BIS values falling below 80 and the difference between treatment arm means in BIS values and b)To gather and generate data from which the sample size of a definitive RCT can be estimated. Criteria for progression to formal RCT were as follows, a)We suggest that the minimum clinically important difference (MCID) between treatment arms should be estimated as a difference in mean BIS value of = 10 and a difference of patients in whom BIS values drop below 80 that is = 20%, b)Sample size for a definitive RCT is to be calculated and judged whether feasible or not. We recommend that sample sizes up to 300 patients in total would be reasonable to execute as a formal RCT. After completion of data collection, that is after July 2020
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tygerberg Hospital Corner of Francie van Zijl avenue and Hospital drive, Parow, Cape Town, 7505 Cape Town 7505 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
The Jan Pretorius Research Fund provided by The South African Society of Anaesthesiologists The SASA National Secretary The Jan Pretorius Research Fund P O Box 1935 Durban 4000 Durban 4000 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Anaesthesiology and Critical Care Faculty of Medicine and Health Sciences Stellenbosch University Department of Anaesthesiology and Critical Care Clinical Building Room 2041, 2nd Floor Francie van Zijl Drive Tygerberg 7 Cape Town 7505 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr Rubendren Naidoo Rivonia Road, Suite 311, Mediclinic Morningside, Morningside, 2021 Johannesburg 2021 South Africa
Professor Sean Chetty Stellenbosch University Faculty of Medicine and Health Sciences Department of Anaesthesiology and Critical Care Clinical Building Room 2041, 2nd Floor Francie van Zijl Drive Tygerberg 7505 Cape Town South Africa Cape Town 7505 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Friederike Scannell rike.sittmann@gmail.com 0027828533093 Stellenbosch University Faculty of Medicine and Health Sciences Department of Anaesthesiology and Critical Care Clinical Building Room 2041, 2nd Floor Francie van Zijl Drive Tygerberg 7505 Cape Town
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Registrar Department of Anaesthesiology and Critical Care
Role Name Email Phone Street address
Public Enquiries Nadeema Williams nadeemaw@sun.ac.za 0027219389028 Stellenbosch University Faculty of Medicine and Health Sciences Department of Anaesthesiology and Critical Care Clinical Building Room 2041, 2nd Floor Francie van Zijl Drive Tygerberg 7505 Cape Town
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Administrative Officer
Role Name Email Phone Street address
Scientific Enquiries Hazel Dreyding hdryding@sun.ac.za 0027219389030 Stellenbosch University Faculty of Medicine and Health Sciences Department of Anaesthesiology and Critical Care Clinical Building Room 2041, 2nd Floor Francie van Zijl Drive Tygerberg 7505 Cape Town S
City Postal code Country Position/Affiliation
Cape Town 7505 South Africa Personal Assistant to Prof. Sean Chetty Head of Department of Anaesthesiology and Critical Care Stellenbosch University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data underlying the results reported in published article will, after deidentification, be made available (tables, figures, text and appendices upon request). Study protocol, data analysis plan, consent form and analytic code will also be made available. Data will be available 3 months after publication, then for 5 years. Researchers who wish to include data from this article in their own research can apply to Stellenbosch University for permission at www.sun.ac.za/permission. Analytic Code,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data available 3 months after publication, then for 5 years. Data access is controlled by Stellenbosch University. Individual participant data underlying the results reported in published article will, after deidentification, be made available (tables, figures, text and appendices upon request). Study protocol, data analysis plan, consent form and analytic code will also be made available. Data will be available 3 months after publication, then for 5 years. Researchers who wish to include data from this article in their own research can apply to Stellenbosch University for permission at www.sun.ac.za/permission.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
www.sun.ac.za/permission. No
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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