CIA: Consent in Anaesthesia, Prospective Randomised-controlled Trial
Phase: NA
Conditions: Regional Anesthesia, Patient Satisfaction
Sponsor: Imperial College Healthcare NHS Trust

 
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CIA 
 
 
 
 
CIA: Consent in Anaesthesia 
 
 
 
 
V6. 01.10.2023 
 
 
 
 
MAIN SPONSOR: Imperial College Healthcare NHS Trust  
FUNDERS: Imperial Health Charity 
STUDY COORDINATION CENTRE: St Mary’s Hospital 
 
IRAS Project ID: 305199 
REC reference: North West London 
 
 
 
Protocol authorised by: 
 
Name & Role 
Date 
Signature 
Dr Boyne Bellew 
Chief Investigator 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Study Management Group 
 
Chief Investigator: Dr Boyne Bellew 
Co-investigators: Dr Chris Mullington, Prof William Harrop-Griffiths 
 
Statistician: Mr Roger A’Hern 
 
Study Management: Dr Boyne Bellew 
 
Study Coordination Centre  
 
For general queries, supply of study documentation, and collection of data, please 
contact: 
 
Study Coordinator: Boyne Bellew 
Address: Department of Anaesthesia & Critical Care, 
               St Mary’s Hospital, Paddington 
               Anaesthesia / Critical Care / Theatres, Specialist Services - CPG 3 
               4th Floor, QEQM Building, St Mary’s Hospital, Praed Street,  
               London W2 1NY 
 
 
 
 
 
 
Registration: GMC 700811 
Tel: 07710787321   
 
 
E-mail:  boyne.bellew@nhs.net  
 
 
 
 
 
 
Clinical Queries 
 
Clinical queries should be directed to Dr Boyne Bellew who will direct the query to 
the appropriate person 
 
Sponsor 
 
Imperial College Healthcare NHS Trust is the main research Sponsor for this study.  
For further information regarding the sponsorship conditions, please contact the 
Head of Regulatory Compliance at: 
 
 
 
Research Governance and Integrity Team 
Imperial College London and Imperial College Healthcare NHS Trust 
Room 215, Level 2, Medical School Building 
Norfolk Place 
London, W2 1PG 
Tel: 0207 594 9459/ 0207 594 1862 
http://www3.imperial.ac.uk/clinicalresearchgovernanceoffice  
 
Funder 
 
Imperial Health Charity 
 

 
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This protocol describes the CIA study and provides information about procedures for entering 
participants.  Every care was taken in its drafting, but corrections or amendments may be necessary. 
These will be circulated to investigators in the study.  Problems relating to this study should be referred, 
in the first instance, to the Chief Investigator.  
 
This study will adhere to the principles outlined in the UK Policy Frame Work for Health and Social Care 
Research. It will be conducted in compliance with the protocol, the Data Protection Act and other 
regulatory requirements as appropriate.  
 
Table of Contents                                                                      Page No 
1. 
INTRODUCTION 
6 
2. 
STUDY OBJECTIVES 
7 
3. 
RESEARCH PLAN AND METHODOLOGY 
8 
3.1. 
STUDY POPULATION 
8 
3.2. 
STUDY DESIGN 
8 
3.3. 
RECRUITMENT 
9 
3.4. 
PROTOCOL 
10 
3.5. 
MEASUREMENTS 
10 
3.6. 
WITHDRAWAL CRITERIA 
11 
4. 
ADVERSE EVENTS 
11 
4.1. 
DEFINITIONS 
11 
4.2. 
REPORTING PROCEDURES 
12 
5. 
ASSESSMENT AND FOLLOW-UP 
12 
6. 
STATISTICS AND DATA ANALYSIS 
13 
7. 
REGULATORY ISSUES 
13 
7.1. 
ETHICS APPROVAL 
13 
7.2. 
CONSENT 
14 
7.3. 
CONFIDENTIALITY 
14 
7.4. 
INDEMNITY 
14 
7.5. 
SPONSOR 
14 
7.6. 
FUNDING 
14 
7.7. 
AUDITS 
14 
8. 
STUDY MANAGEMENT 
14 
9. 
PUBLICATION POLICY 
14 
10. 
REFERENCES 
15 
11. 
APPENDICES 
17 
11.1. 
Client Satisfaction Questionnaire (CSQ-8) 
17 
11.2. 
Health literacy assessment 
17 
11.3. 
Knowledge and Perception Questionnaire 
18 
 
 
 
 
 
GLOSSARY OF ABBREVIATIONS 

 
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AE 
Adverse Event 
ANOVA 
Analysis of Variance 
CSQ 
Client Satisfaction Questionnaire 
DMSC 
Data Monitoring and Safety Committee 
GA 
General Anaesthesia 
ICH GCP 
International Conference for Harmonisation of Good Clinical 
Practice 
ITT 
Intention To Treat 
NVS 
Newest Vital Sign 
PI 
Principal Investigator 
PIS 
Patient Information Sheet 
RA 
Regional Anaesthesia 
REC 
Research Ethics Committee 
SAE 
Serious Adverse Event 
SSA 
Site Specific Assessment 
SVC  
Standard Verbal Consent 
TMG 
Trial Management Group 
VAC 
Video Assisted Consent 
 
 
 
 
 
 
 
 
 
KEYWORDS 
Consent 
Video 
Anaesthesia 
Regional 
Satisfaction 
Knowledge 
 
 
 
 
 
 
 
 

 
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STUDY SUMMARY 
 
 
TITLE CIA: Consent in Anaesthesia 
DESIGN Prospective randomised-controlled trial 
AIM To determine whether presenting both techniques of general 
anaesthesia and regional anaesthesia in an unbiased manner, with 
video media, aids the anaesthetic consent process, compared to 
standard verbal consent alone. 
OUTCOME 
 MEASURES 
Primary outcome:  
- 
Participants’ satisfaction regarding the anaesthetic consent 
process  
Secondary outcomes:  
- 
Knowledge, attitudes and practices towards anaesthesia 
- 
Participants’ choice of anaesthetic technique 
POPULATION General adult population (>18yrs), males and females 
ELIGIBILITY Adult participants (>18yrs) who give written, informed consent. 
Exclusion criteria: 
- 
Patients <18 years or vulnerable groups 
- 
Inability to communicate in English or language difficulty that 
requires an interpreter 
- 
Severe vision or hearing loss if lack of other communication 
channels 
- 
Private patients 
- 
Prisoners 
- 
Patients who reside outside the United Kingdom (home 
address) 
- 
Opt-out patients on GP register 
DURATION 2 years 
 
 
 
 
 
 
 
 
 
 
 

 
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1. INTRODUCTION  
 
Anaesthetists deliver just under 3 million anaesthetics in the United Kingdom every year1,2. 
General anaesthesia (GA) and regional anaesthesia (RA) are both routinely used for 
intraoperative anaesthesia. The estimated annual numbers (with percentage of all cases) of 
GA, sedation and awake cases were 2 766 600 (76.9%), 308 800 (8.6%), and 523 100 
(14.5%), respectively2.  
 
Regional anaesthesia with central neuraxial or peripheral nerve plexus blockade has a 
proven track record for success in surgery and several potential benefits. It may be 
undertaken with or without sedation. General anaesthesia is associated with greater 
immediate post-operative pain and opiate use3, whereas brachial plexus blockade may be 
associated with delayed rebound pain4. However, rebound pain may be modulated by an 
understanding of the dissipation of single-injection regional anaesthesia and attenuated by 
longer duration analgesia as well as multi-modal therapy5,6. When regional anaesthesia has 
been used instead of general anaesthesia, the median time to hospital discharge is 
shortened and the in-hospital mortality is also decreased.  
 
There are a number of surgical procedures which may be undertaken under either general 
anaesthesia or regional anaesthesia. The Association of Anaesthetists of Great Britain and 
Ireland guidelines on consent state that for a decision by an individual to be valid, it must 
have been undertaken voluntarily, without coercion8,9,10. Although it may be good practice for 
the clinician seeking consent to indicate a preference for a therapeutic option, they should be 
aware that a vulnerable patient may feel coerced by the doctor’s preference due to the 
imbalance of power and influence in the doctor-patient relationship. The anaesthetist 
seeking consent should be aware of this and not allow their preferences to override the 
patients autonomy8,11. When these principles are applied to the type of anaesthesia (GA vs 
RA) offered, it stands to reason that both options of GA and RA should be offered to 
patients, if both are feasible options for the surgery to be undertaken. Barriers to this are 
multifactorial and the time pressures of a busy anaesthetic list should not be underestimated.  
 
Video assisted consent (VAC) offers a potential way to improve doctor-patient 
communication and to improve the consent process when compared to standard verbal 
consent (SVC)12. Hand-held, mobile media devices are becoming ever more prevalent and 
lend themselves to easy use within a busy hospital environment. The role of video-based 
education in the process of consent has shown promise in studies of surgical consent. 
Several studies have shown that video-based patient education have led to better patient 
comprehension and satisfaction as well as reduced patient anxiety during the consent 
process12-15. The acceptance of multimedia technology in preoperative surgical consent has 
been demonstrated across a spread of surgical disciplines, including ophthalmic surgery16-17, 
urological surgery12, orthopaedic surgery15,18-19, bariatric surgery20 and vascular surgery21.  
The use of video-assisted consent for invasive procedures on the intensive care unit has 
also had positive results22. 
 
The choice of general vs regional anaesthesia by a patient undergoing orthopaedic surgery 
has been demonstrated to change with patient education. In a randomised controlled trial in 
Cardiff, the use of informational internet web pages led to patients awaiting hip or knee 
arthroplasty altering their preferences from general anaesthesia to a neuroaxial technique23. 
Preoperative patient education of the advantages of neuroaxial anaesthesia was also shown 
to be associated with a higher number of patients choosing a regional anaesthetic in the 
setting of total knee arthroplasty24.  

 
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A tertiary centre trial in the UK demonstrated that patient recall of consent for regional 
anaesthesia was poorer than that for surgical consent25. Video-assisted patient education 
during a preanaesthetic visit has been shown to lead to a better understanding of the 
procedure and risks of anaesthesia with no increase in patient anxiety26. This suggests that 
more effective strategies for patient education with regards to regional anaesthesia and 
consent for regional anaesthesia are required and video-assisted methods are likely to be 
beneficial. 
 
Patient and Public Involvement and Engagement (PPIE) work consisted of consulting 40 
members of the multidisciplinary theatre team, including consultants, trainees, operating 
department practitioners and nurses. Although 92% of those surveyed had not used a video- 
assisted consent process before, 95% felt that a video-assisted consent process would be a 
useful tool. 88% of those surveyed had not used or seen any type of online consent tool but 
92% voted that an anaesthetic online consent process would be useful. The team has also 
spoken to patients and lay public who have also felt that a video-assisted consent process 
would help with their understanding and satisfaction of the consent process should they 
need to have an anaesthetic for surgery.  
 
The COVID pandemic has brought about changes in pre-operative assessment and 
anaesthetic consent27. The need for social distancing has meant that family and friends are 
often no longer able to be present when the patient meets the anaesthetist on the day of 
surgery to discuss the anaesthetic process and options; as well as to obtain anaesthetic 
consent. The videos created specifically for video-assisted anaesthetic consent could not 
only be used to allow the patient to review the anaesthetic process in advance of the 
anaesthetic consent to allow time for informed consent, they could also be reviewed with 
family and friends that the patient may depend on for support and advice 
 
 
 
 
2. STUDY OBJECTIVES 
 
• 
The aim of this study is to determine if the use of video assisted consent during the 
anaesthetic consent process, for both GA and RA, affects the participants’ 
satisfaction, knowledge of, and attitudes towards, anaesthesia. 
 
• 
We hypothesise that using video media will improve participant knowledge, 
understanding and satisfaction of the anaesthetic consent process, thereby resulting 
in better quality informed consent. 
 
 
 
 
 
 
 
 
 
 
 

 
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3. RESEARCH PLAN AND METHODOLOGY 
 
 
3.1. 
STUDY POPULATION 
 
Study centre(s) 
 
• 
Imperial College Healthcare NHS Trust 
 
Study sample 
 
• 
206 participants 
 
Inclusion criteria 
 
• 
≥ 18 years 
• 
Presenting to pre-operative orthopaedic surgical clinic 
• 
Informed consent 
 
Exclusion criteria 
 
• 
Patients <18 years or vulnerable groups 
• 
Inability to communicate in English or language difficulty that requires an interpreter 
• 
Severe vision or hearing loss if lack of other communication channels 
• 
Private patients 
• 
Prisoners 
• 
Patients who reside outside the United Kingdom (home address) 
• 
Opt-out patients on GP register 
 
 
3.2. 
STUDY DESIGN 
 
• 
Single centre prospective randomised-controlled trial 
• 
Duration: 2 years 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Figure 1 – Study Design Flow Chart 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
This is a prospective, randomised-controlled trial investigating the effects of using video 
media to aid the anaesthetic consent process.  
 
3.3. 
RECRUITMENT 
Potential trial participants will be recruited from the general adult population (i.e. males and 
females aged over 18yrs) presenting to pre-operative orthopaedic surgical clinic within 
Imperial College Healthcare NHS Trust at St Mary's and Charing Cross Hospitals. Potential 
participants will be approached by members of the study team that may or may not be part 
of the primary care team.  All potential participants will be invited to take part with the use of 
a participant information sheet (PIS), approved by a Research Ethics Committee, that 
describes the study. The participant will have time to read the PIS and to discuss their 
participation with others outside the research team (e.g. relatives or friends) if they wish. A 
Recruitment at Study Sites 
Study Enrolment 
 
•
Collection of baseline demographic data 
(age, gender, ethnicity, education level) 
•
Health literacy questionnaire 
Excluded based on 
inclusion/exclusion 
criteria 
Randomisation 
Intervention Group 
Video assisted consent process 
Control Group 
Standard video verbal consent 
Assessment 
 
•
Patient satisfaction using CSQ-8 
questionnaire 
•
Knowledge, Attitude and Practice 
Questionnaire 
•
Stated preference for anaesthetic 
technique (GA or RA) 

 
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member of the research team will then answer any questions, confirm the participant’s 
eligibility and take written informed consent if the participant decides to proceed. Details of 
all participants approached for the trial and reason(s) for non-participation (e.g. reason for 
being ineligible or patient refusal) will be documented.  Also the non-participant does not 
need to give a reans for non-participation and if so will be documented as non-participation 
in the reason(s) for refusal. 
All data will be anonymised. 
 
3.4. 
PROTOCOL 
Recruited participants will be randomised into two groups. The control group will undergo the 
standard video verbal consent process for both GA and RA for orthopaedic surgery. This will 
be delivered using a standardised video script that will be generated from existing certified 
material, as well as being reviewed by an experienced body of anaesthetists, in order to 
ensure that the length and content of information given is appropriate, unbiased, accurate 
and consistent. In order to account for adaptations to services in light of the coronavirus 
pandemic, and to further ensure standardisation, this verbal communication will be pre-
recorded and shown to the participant. The intervention group will also be shown the same 
pre-recorded standard verbal consent, but following this will additionally be shown a 
specifically recorded video of the anaesthetic process for both GA and RA. This video will 
aim to communicate the same information as that found in the traditional verbal consent, 
using an actor undergoing an anaesthetic to provide context. 
 
Following the consent process, participants from both groups will be asked to complete two 
questionnaires to enable assessment of participant satisfaction, retained knowledge and 
perceptions regarding anaesthesia from the consent process, and a stated preference for 
anaesthetic technique (i.e. GA or RA).  
 
3.5. 
MEASUREMENTS 
Following recruitment, baseline demographic data will be collected on each participant, 
including age, gender, ethnicity and education level. 
 
Health literacy is the degree to which individuals have the capacity to obtain, process, and 
understand basic health information and services needed to make appropriate health 
decisions28. Health literacy may be an important confounding factor within this study; 
therefore, assessing health literacy will be a useful screening tool prior to conducting the 
study. Prior to randomisation, participants will be asked to complete the Newest Vital Sign-
UK questionnaire (see appendix 11.2) to assess health literacy. 
 
For measuring the primary outcome, participant satisfaction, the Client Satisfaction 
Questionnaire (CSQ-8) will be utilised, which measures the most salient items for the 
satisfaction with services (see appendix 11.1). This will be administered for the control group 
after receiving standard verbal consent, and the intervention group after receiving video 
assisted consent. 
 
For measuring the secondary outcomes, a knowledge, attitudes and practices (KAP) 
questionnaire will be utilised (see appendix 11.3). As part of the questionnaire, the 
participant will be offered the choice of anaesthetic technique between GA and RA. This is to 
evaluate whether the proportions choosing GA or RA differ between control and intervention 
groups. 
 
 
 

 
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3.5.1. Summary of pre-randomisation actions 
 
Event 
Measurement/Action 
Means 
Timing 
Time 
Recruit 
participants 
Inform participants 
Participant 
Information Sheet 
At 
time 
of 
recruitment 
5-10 
minutes 
Consent 
participants 
Informed written consent 
Online 
consent 
form 
At 
time 
of 
consent 
5 minutes 
Demographic 
data collection 
Age, 
gender, 
ethnicity, 
education level 
Online 
questionnaire 
Once 
consented 
2-3 
minutes 
Health Literacy 
Assessment 
Newest Vital Sign-UK 
Online 
questionnaire 
Once 
consented 
3-5 
minutes 
 
 
3.5.2. Summary of Study Outcome Measurement 
 
Outcome 
Data 
Measurement Tool 
Timing 
Time 
Primary 
Outcome 
Participant satisfaction 
Client Satisfaction 
questionnaire (CSQ-8) 
Following 
intervention 
3 minutes 
Secondary 
Outcomes 
Knowledge, attitudes and 
practices towards general 
and regional anaesthesia 
KAP questionnaire 
Following 
intervention 
 
 
 
 
5-10 
minutes 
Stated 
preference 
of 
anaesthetic technique 
KAP questionnaire 
Following 
intervention 
<1 minute 
 
3.6. 
WITHDRAWAL CRITERIA  
Each participant has the right to withdraw at any time. If a participant withdraws, we will 
continue to analyse any data already collected, unless the participant expresses a wish for 
any associated data to be destroyed. 
 
 
4. ADVERSE EVENTS  
 
4.1. 
DEFINITIONS  
Adverse Event (AE): any untoward medical occurrence in a patient or clinical study subject.   
 
Serious Adverse Event (SAE): any untoward and unexpected medical occurrence or effect 
that: 
• 
Results in death 
• 
Is life-threatening – refers to an event in which the subject was at risk of death at the 
time of the event; it does not refer to an event which hypothetically might have caused 
death if it were more severe 
• 
Requires hospitalisation, or prolongation of existing inpatients’ hospitalisation 
• 
Results in persistent or significant disability or incapacity 
• 
Is a congenital anomaly or birth defect 
 
Medical judgement should be exercised in deciding whether an AE is serious in other 
situations.  Important AEs that are not immediately life-threatening or do not result in death or 
hospitalisation but may jeopardise the subject or may require intervention to prevent one of 
the other outcomes listed in the definition above, should also be considered serious. 
 

 
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4.2. 
REPORTING PROCEDURES  
All adverse events should be reported.  Depending on the nature of the event the reporting 
procedures below should be followed.  Any questions concerning adverse event reporting 
should be directed to the Chief Investigator in the first instance.   
 
 
 
 
4.2.1 Non serious AEs 
All such events, whether expected or not, should be recorded- it should be specified if only 
some non-serious AEs will be recorded, any reporting should be consistent with the 
purpose of the trial end points.  
 
4.2.2 Serious AEs 
An SAE form should be completed and emailed to the Chief Investigator within 24 hours.  
 
All SAEs should be reported to the North West London REC where in the opinion of the 
Chief Investigator, the event was: 
• 
‘related’, ie resulted from the administration of any of the research procedures; and 
• 
‘unexpected’, ie an event that is not listed in the protocol as an expected occurrence 
 
Reports of related and unexpected SAEs should be submitted within 15 days of the Chief 
Investigator becoming aware of the event, using the NRES SAE form for non-IMP studies.  
The Chief Investigator must also notify the Sponsor of all related and unexpected SAEs. 
 
Local investigators should report any SAEs as required by their Local Research Ethics 
Committee, Sponsor and/or Research & Development Office. 
 
 
Contact details for reporting SAEs 
RGIT@imperial.ac.uk 
CI email (and contact details below) 
Please send SAE forms to: Boyne Bellew (boyne.bellew@nhs.net) 
Tel: 07710787321 (Mon to Fri 09.00 – 17.00) 
 
 
5. ASSESSMENT AND FOLLOW-UP  
 
Baseline demographic data will be collected for all study patients. These will include age, 
gender, ethnicity and educational level. 
 
Assessment will be carried out using the following tools: 
• 
CSQ-8 satisfaction questionnaire (appendix 12.1) 
• 
Newest Vital Sign (NVS)-UK (appendix 12.2)   
• 
Knowledge, Attitudes and Practice questionnaire (appendix 12.3), based on 
information contained in the consent process 
 
Each participant, with their consent, will be informed of the outcome of the trial and any 
subsequent publication. There is no requirement for follow-up after the investigative period. 

 
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There is unlikely to be any losses as the participant will undertake the 2 questionnaires and 
state their theoretical choice of anaesthesia immediately after undergoing either the 
traditional verbal consent process and/ or the video-assisted consent process. The only 
possible loss would be if the participants abruptly withdraws consent to participate if called 
away for clinical or personal reasons. 
 
The end of the trial will be when the trial database is complete and locked for analysis. 
 
6. STATISTICS AND DATA ANALYSIS 
Two hundred and six patients in total will be randomised using an online randomisation tool. 
https://www.graphpad.com/quickcalcs/randomize1.cfm 
Patient satisfaction, the primary endpoint measured by CSQ-8, is expected to be 
approximately 30 in both arms. VAC and SVC will be considered equivalent if the VAC 
satisfaction score is no more than 1.5 points lower than the SVC score. With 103 subjects in 
the Control Group (SVC) and 103 subjects in Experimental Group (VAC), there is an 85% 
chance that the observed difference (SVC-VAC) in satisfaction scores will be 
significantly less than 1.5 at the 5% level, if the true means are 30 in both groups. The 
standard deviation has been assumed to be 4. 
After the first 50 participants have been entered into the trial a feasibility analysis will be 
undertaken. Three outcomes of particular interest will be the accrual rate, the proportion 
accepting their randomisation and the proportion evaluable (completing all questionnaires). 
With 50 participants it will be possible to estimate the proportions in the latter two groups 
with 95% confidence intervals of at most ±15%. A record will be kept of the number of 
participants approached and their reasons for declining to enter the study. With 50 
participants it should be possible to identify and remedy any minor issues that are 
impediments to recruitment. It may be necessary to plan to increase accrual if withdrawals or 
the number of non-evaluable participants is greater than expected. 
The primary analysis will be by intention to treat (ITT). It is planned to make comparisons 
between groups for normally distributed variables with independent samples t-test or 
ANOVA, variables that are not normally distributed will be analysed with Mann–Whitney U-
tests. The Chi-squared or Fisher’s exact test will be used to compare proportions and 
Pearson Product or Spearman Rank statistics will be used to assess correlation. Multiple 
regression exploratory analyses may be employed to estimate multiple effects 
simultaneously. 
 
Data and all appropriate documentation will be stored for a minimum of 5 years after the 
completion of the study, including the follow-up period.   
 
 
7. REGULATORY ISSUES  
 
7.1. 
ETHICS APPROVAL  
The Study Coordination Centre has obtained approval from the North West London Research 
Ethics Committee (REC) and Health Regulator Authority (HRA). The study must also receive 
confirmation of capacity and capability from each participating NHS Trust before accepting 

 
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participants into the study or any research activity is carried out. The study will be conducted 
in accordance with the recommendations for physicians involved in research on human 
subjects adopted by the 18th World Medical Assembly, Helsinki 1964 and later revisions. 
 
7.2. 
CONSENT   
Consent to enter the study must be sought from each participant only after a full explanation 
has been given, an information leaflet offered and time allowed for consideration.  Signed 
participant consent should be obtained.  The right of the participant to refuse to participate 
without giving reasons must be respected.  After the participant has entered the study the 
clinician remains free to give alternative treatment to that specified in the protocol at any stage 
if he/she feels it is in the participant’s best interest, but the reasons for doing so should be 
recorded.  In these cases the participants remain within the study for the purposes of follow-
up and data analysis.  All participants are free to withdraw at any time from the protocol 
treatment without giving reasons and without prejudicing further treatment. 
 
7.3. 
CONFIDENTIALITY  
The Chief Investigator will preserve the confidentiality of participants taking part in the study 
and is registered under the Data Protection Act. 
 
Data will be pseudonymised. 
 
7.4. 
INDEMNITY 
Imperial College Healthcare NHS Trust holds standard NHS Hospital Indemnity and insurance 
cover with NHS Resolution for NHS Trusts in England, which apply to this study. 
 
7.5. 
SPONSOR  
Imperial College Healthcare NHS Trust will act as the main Sponsor for this study.  Delegated 
responsibilities will be assigned to the NHS trusts taking part in this study.   
 
7.6. 
FUNDING  
Imperial Health Charity are funding this study (via the Innovate Grant) 
 
7.7. 
AUDITS   
The study may be subject to audit by Imperial College London/ Imperial College Healthcare 
NHS Trust under their remit as sponsor and other regulatory bodies to ensure adherence to 
GCP and the UK Policy Frame Work for Health and Social Care Research.  
 
 
8. STUDY MANAGEMENT  
 
The day-to-day management of the study will be co-ordinated through a Trial Management 
Group. This will be chaired by the Chief Investigator and will include all members of the named 
research team  
 
 
9. PUBLICATION POLICY  
 
Results will be published in a peer-reviewed journal and presented at relevant national and 
international conferences. 
 

 
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10.  REFERENCES  
1. Woodall NM, Cook TM. National census of airway management techniques used for 
anaesthesia in the UK: first phase of the Fourth National Audit Project at the Royal 
College of Anaesthetists. Br J Anaesth 2011; 106:266-271. 
2. Sury MRJ, Palmer JHMG, Cook TM et al. The State of UK Anaethesia: a survery of 
national Health Service activity in 2013. 
3. O’Donnell BD, Ryan H, O’Sullivan O, et al. Ultrasound-guided axillary plexus block 
with 20ml local anaesthetic mixture versus general anaesthesia for upper limb 
trauma surgery: An observer-blinded, prospective, randomized, controlled trial. Anes 
Analg 2009;109(1):279-83. 
4. Galos DK, Taormina DP, Crespo A, et al. Does brachial plexus blockade result in 
improved pain scores after distal radius fracture fixation? A randomized trial. Clin 
Orthop Relat Res 2016;474:1247-54. 
5. Mulroy MF, Larkin KL, Batra MS, et al. Femoral nerve block with 0.25% or 0.5% 
bupivacaine improves postoperative analgesia following outpatient arthroscopic 
anterior cruciate ligament repair. Reg Anesth Pain Med 2001;23(1):24-9. 
6. Williams BA, Bottegal MT, Kentor ML, et al. Rebound pain scores as a function of 
femoral nerve block duration after anterior cruciate ligament reconstruction: 
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7. Bulka CM, Shotwell MS, Gupta RK, et al. Regional anaesthesia, time to hospital 
discharge, and in hospital mortality- A propensity score matched analysis. Reg 
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8. Yentis SM, Hartle AJ, Barker IR, et al. AAGBI: Consent for Anaesthesia 2017. 
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9. General Medical Council. Consent: patients and doctors making decisions together. 
London: GMC, 2008. 
http://www.gmc.uk.org/guidance/ethical_guidance/consent_guidance_contents.asp 
10. Re T (Adult refusal of treatment) [1993] Fam 95. 
11. Department for health. Reference guide to consent for examination or treatment. 
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6/dh_103653__1_.pdf 
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15. Mawhinney G, Thakar C, Williamson V, et al. Oxford Video Informed Consent Tool 
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13:116 
 
 
 
 

 
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11.  APPENDICES 
 
11.1. CLIENT SATISFACTION QUESTIONNAIRE (CSQ-8) 
 
The Client Satisfaction Questionnaire (CSQ) instruments are self-report questionnaires 
constructed to measure satisfaction with services received by individuals29.  
The CSQ-8 is an 8-item questionnaire that measures the most salient items for the 
measurement of satisfaction with services: 
 
Questionnaire Item 
Scoring 
4 
3 
2 
1 
How would you rate the quality of the 
service you received? 
Excellent 
Good 
Fair 
Poor 
Did you get the kind of service you 
wanted? 
Yes 
definitely 
Yes 
generally 
No not at 
all 
No 
definitely 
not 
To what extent has our service met 
your needs? 
Almost all 
met 
Most met 
Only a few 
met 
None met 
If a friend were in need of similar 
help would you recommend our 
service? 
Yes 
definitely 
Yes I 
think so 
No I do not 
think so 
Definitely 
not 
How satisfied are you with the 
amount of help you received? 
Very 
satisfied 
Mostly 
satisfied 
Indifferent 
Quite 
dissatisfied 
Have the services you received 
helped you to deal more effectively 
with your problems? 
Yes a 
great deal 
Yes 
somewhat 
No did not 
help 
No made it 
worse 
In an overall sense, how satisfied 
are you with the service you have 
received? 
Very 
satisfied 
Mostly 
satisfied 
Indifferent 
Quite 
dissatisfied 
If you were seeking help again, 
would you come back to our 
service? 
Yes 
definitely 
Yes I 
think so 
No I do not 
think so 
No 
definitely 
not 
 
 
11.2. HEALTH LITERACY ASSESSMENT 
 
Health literacy is defined as ‘the cognitive and social skills that determine the motivation and 
ability of individuals to gain access to, understand and use information in ways that promote 
and maintain good health’28. 
 

 
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Health literacy may be an important confounding factor within this study. The Newest Vital 
Sign (NVS)-UK is a simple, accurate and validated predictor of health literacy skills that has 
been shown to take on average 3 minutes to complete, and can be administered by both 
clinical and non-clinical personnel30. 
 
NVS consists of a food nutrition label with six associated questions giving scores from 0 to 6  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
11.3.  KNOWLEDGE AND PERCEPTION QUESTIONNAIRE 
 
SECTION1: PREVIOUS EXPERIENCE 
1.     Have you been anaesthetised before? Yes ___   No ___ 
         1.1  If so, what type (or types) of anaesthesia? 

 
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General anaesthesia ___ 
Spinal or epidural (lower half of the body) ___ 
Nerve block (for example only arm, hand or foot anaesthesia) ____ 
Local anaesthesia ____ 
     
2.     If you have been anaesthetised, have you experienced any complication 
related to anaesthesia? 
Yes ___ What? 
______________________________________________________________
___ 
No ___ 
I have never been anaesthetised ____ 
 
3.     Do you know anyone who has experienced complications related to 
regional anaesthesia? 
Yes ___ What? 
_____________________________________________________________
____ 
No ___ 
 
SECTION 2: KNOWLEDGE OF ANAESTHESIA 
4.     How many options do you have for your anaesthetic for your operation? 
 
 
0 ___  1 ___  2 ___  More than 2 ___  Don’t Know ___ 
 
5.    Having which type of anaesthetic will mean that you are awake for your 
surgery? 
 
 
General ___  Regional ___  Both ___  Don’t Know ___ 
 
6.   Which type of anaesthetic is associated with the following statements: 
 
A cannula is inserted into your hand  
General ___  Regional  ___  Both 
___  Don’t Know ___ 
 
Monitors are applied to your body  
General ___  Regional ___  Both ___  
Don’t Know ___ 
 
A tube is inserted into your throat    
General ___  Regional ___  Both ___  
Don’t Know ___ 
You can listen to your own music  General ___  Regional ___  Both ___  Don’t 
Know ___ 
 
You will have a heavy, numb arm  
General ___  Regional ___ Both ___ 
Don’t Know ___ 
 
7.   When having general anaesthesia, how common is it to experience each 
one of the following events? 
How common is it to: 
Very 
rare 
Rar
e 
Uncomm
on 
Commo
n 
Very 
Commo
n 
Experience nausea or vomiting 
1 
2 
3 
4 
5 
Have a sore throat 
1 
2 
3 
4 
5 

 
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Suffer confusion, disorientation or 
memory loss 
1 
2 
3 
4 
5 
Experience pain whilst having the 
anaesthetic  
1 
2 
3 
4 
5 
Feel anything during surgery 
1 
2 
3 
4 
5 
Have damage caused to your teeth 
1 
2 
3 
4 
5 
Have permanent nerve damage 
1 
2 
3 
4 
5 
Suffer a life-threatening event 
1 
2 
3 
4 
5 
Be aware of your surroundings during 
surgery 
1 
2 
3 
4 
5 
8.   When having regional anaesthesia (nerve block), how common is it to 
experience each one of the following events? 
How common is it to: 
Very 
rare 
Rar
e 
Uncomm
on 
Commo
n 
Very 
Commo
n 
Experience nausea or vomiting 
1 
2 
3 
4 
5 
Have a sore throat 
1 
2 
3 
4 
5 
Suffer confusion, disorientation or 
memory loss 
1 
2 
3 
4 
5 
Experience pain whilst having the 
anaesthetic  
1 
2 
3 
4 
5 
Feel anything during surgery 
1 
2 
3 
4 
5 
Have damage caused to your teeth 
1 
2 
3 
4 
5 
Have permanent nerve damage 
1 
2 
3 
4 
5 
Suffer a life-threatening event 
1 
2 
3 
4 
5 
Be aware of your surroundings during 
surgery 
1 
2 
3 
4 
5 
 
9.   For the following statements, choose general anaesthesia or regional 
anaesthesia as the best option: 
It is easier to manage postoperative pain.   
General ___ Regional  ___  Don’t 
Know ___ 
You will need less painkillers after your operation.   General ___ Regional ___  Don’t 
Know ___ 
You will be able to eat and drink straight away.   General ___ Regional ___  Don’t 
Know ___ 
You will be able to go home more quickly. General ___ Regional ___  Don’t Know 
____ 
You will feel like your normal self more quickly.   General ___  Regional ___ Don’t 
Know ____ 
 
SECTION 3: ATTITUDES TO ANAESTHESIA 
10.   How anxious do you feel about having an anaesthetic? 
Very calm ___  Calm ___  Slightly anxious ___  Anxious ___  Very anxious 
___ 
 

 
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11.   Do you consider general anaesthesia as a: 
Very safe procedure ___  Safe procedure ___  Risky procedure ___  Very 
risky procedure ___ 
 
12.   Do you consider regional anaesthesia (nerve block) as a: 
Very safe procedure ___  Safe procedure ___  Risky procedure ___  Very 
risky procedure ___ 
13.   How do you feel about the possibility of being awake during the surgery? 
Very calm ___ Calm ___  Slightly anxious ___  Anxious ___  Very anxious 
___ 
 
14.   Imagine that you are having a general anaesthetic. How afraid are you 
about each of the following events? 
How afraid are you of: 
Very 
unafrai
d 
Unafraid 
Neither 
afraid or 
unafraid 
Afraid 
Very 
Afraid 
Experiencing nausea or vomiting 
1 
2 
3 
4 
5 
Having a sore throat 
1 
2 
3 
4 
5 
Suffering confusion, disorientation 
or memory loss 
1 
2 
3 
4 
5 
Experiencing pain whilst having 
the anaesthetic  
1 
2 
3 
4 
5 
Feeling anything during surgery 
1 
2 
3 
4 
5 
Having damage caused to your 
teeth 
1 
2 
3 
4 
5 
Having permanent nerve damage 
1 
2 
3 
4 
5 
Suffering a life-threatening event 
1 
2 
3 
4 
5 
Being aware of your surroundings 
during surgery 
1 
2 
3 
4 
5 
 
15.   Imagine that you are having regional anaesthesia. How afraid are you 
about each of the following events? 
How afraid are you of: 
Very 
unafrai
d 
Unafraid 
Neither 
afraid or 
unafraid 
Afraid 
Very 
Afraid 
Experiencing nausea or vomiting 
1 
2 
3 
4 
5 
Having a sore throat 
1 
2 
3 
4 
5 
Suffering confusion, disorientation 
or memory loss 
1 
2 
3 
4 
5 
Experiencing pain whilst having 
the anaesthetic  
1 
2 
3 
4 
5 
Being in pain or feeling anything 
during surgery 
1 
2 
3 
4 
5 
Having damage caused to your 
teeth 
1 
2 
3 
4 
5 
Having permanent nerve damage 
1 
2 
3 
4 
5 

 
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Suffering a life-threatening event 
1 
2 
3 
4 
5 
Being aware of your surroundings 
during surgery 
1 
2 
3 
4 
5 
 
 
SECTION 4: PRACTICES TOWARDS ANAESTHESIA 
16.    Which option for anaesthesia would you choose for your surgery? 
General anaesthesia ___    Regional anaesthesia ___ 
16.1   Why? 
______________________________________________________________
______ 
 
17   If your anaesthetist advised you to have a regional anaesthetic technique, 
would you accept it? 
Yes ___ No ___