DAH -30 Days at home at 30 Days
Proposed sample size The established minimum clinically important difference in
QoR-15 is 8.0 and the SD of QoR-15 scores after major surgery is in the order of 10
[range of QoR score is 1-150]. Therefore, assuming Type I error = 0.05 and Type II
error = 0.2 (80% power to detect this difference), then n=25 patients needed in
each group.
Study Design A prospective, randomised, double-blind controlled trial with
participants masked to study arm (blocks will be performed under General
Anaesthesia) and those involved in data collection also masked to the intervention.
Patients will be asked to complete a questionnaire in the post operative period
(QoR 15) which is a global assessment of the patients post operative recovery
status. The QoR 15 scale is a validated means of assessing a patients quality of
recovery. The questionnaire contains 15 questions and the mean+SD duration of time
taken for patients to complete the questionnaire is 2.4+0.8 min.
Treatment of study subjects Patients scheduled for Spinal Surgery will be screened
for eligibility according to the criteria listed and eligible patients noted. These
patients are admitted the day prior to surgery or morning of surgery when scheduled
for an afternoon list. Eligible patients will be approached by an investigator and
invited to give their consent to the study. They will be offered the Patient
Information Leaflet (PIL) and the investigator will leave the patient for a minimum
of ten minutes to consider. Patients who give written consent will be randomised to
receive either ESB or No Block (control) after induction of general anaesthesia.
Randomisation will be by table of random numbers, even numbers assigned ESB, odd
numbers control. The designated group will then be written on a blank page and
placed in a sealed envelope, which will be sequentially numbered, e.g. Patient
Study Number 1 etc.
Patients will be unconscious under GA when receiving either ESB , so will be masked
to group allocation. Investigators collecting QoR-15 data will also be unaware of
group allocation.
All participants will have standard analgesia (Paracetamol, NSAIDS, Opiates) at the
discretion of the treating Consultant Anaesthetist. 20mls 0.25% Levobupivicaine
plus 2mg Dexamethasone will be used on each side in the ESP block.
Patient characteristics and data will be prospectively recorded for 24 hr
postoperatively. Intraoperative haemodynamic recordings and the use of rescue
analgesia during the operation and in the recovery room will be taken from the
Centricity Anaesthesia Information Management System an electronic recording system
that has been in use in the Mater Anaesthesia department since 2016. Patients will
complete QoR questionnaires manually on paper which will then be transferred into
an electronic format. The questionnaires will be administered by Doctors or Nurses
involved with the study. Patients will be asked to complete the questionnaire while
they are in the recovery area after the operation and once they are fully awake.
Inclusion Criteria Male and Female participants providing written informed consent,
ASA grade 1- 4, age group 18 and over undergoing Posterior approach Spinal surgery
involving 2 or more levels of decompression in the lumbar or thoracic regions.
Exclusion Criteria Absence of informed written consent, pre existing infection at
block site, severe coagulopathy, allergy to local anaesthesia, , previous history
of opiate abuse, pre existing chronic pain condition, pre-existing dementia
[because of need to co-operate in completing QoR-15 score day after surgery],
decompression involving cervical levels of vertebrae
Anticipated study start date
1st August 2019 Anticipated study duration 6 months
Safety Reporting Patients' routine medical care will continue during this clinical
trial as per current practice. Both regional blocks are routinely used in our
institution and therefore the health of participants will be monitored as it would
be for all patients regardless of their participation in the trial. Adverse events
will be recorded and managed along already existing local policies and guidelines.
Statistics QoR and other variables will be compared between the groups using
independent samples (unpaired) t-test for normally distributed continuous data and
Mann-Whitney U test for non-parametric data
Data Handling and record keeping Only the investigators will have access to the
collated data. Data will be recorded initially on paper and then transcribed to
electronic spreadsheet format, in coded format.
Patients' names will not be recorded, study numbers assigned by randomisation will
be recorded. This will allow follow up at 24 hours to assess block performance. The
investigators will retain the "key" to identification. Data will be stored securely
in the Department of Anaesthesia at the Mater Hospital, on a password-protected
desktop computer stored in a locked office, such that only the investigators will
have access.
Electronically-recorded data will be secured by means of password
protection/encryption. Data recorded on paper will be secured by lock and key
Retention of essential documents The collated data collected by the investigators
will be retained for 5 yr after analysis has completed. The original data in the
patients' paper and electronic medical records will be unaffected.
Quality Control and Quality assurance procedures ESP blocks are in routine use in
our department currently. All Blocks will be performed by Anaesthesiologists with
expertise in regional anaesthesia and who are familiar with the study. We will be
following our local and international guidelines in terms of safe block
performance. This would include appropriate monitoring of the patient as set out in
the RA - UK guidelines, availability of resuscitation and airway equipment
including the ready availability of Intra - lipid. All blocks will be performed by
or supervised by experienced Anaesthesiologists using a validated in plane
Ultrasound technique.
Ethics There are no ethical issues regarding this study. Financing and
Insurance/Indemnity All investigators will be MMUH staff covered by the clinical
indemnity scheme [CIS]
Clinical Study Report and publication policy Conclusions from the clinical trial,
once complete, will be prepared for presentation at an academic meeting and for
submission to an appropriate international, peer-reviewed journal