Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001192976
Ethics application status
Approved
Date submitted
13/09/2020
Date registered
10/11/2020
Date last updated
10/11/2020
Date data sharing statement initially provided
10/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Paravertebral vs. Erector Spinae Blocks for lung function in those with rib fractures
Scientific title
Pulmonary function measured by spirometry in patients with acute rib fractures treated with either paravertebral blockade or erector spinae plane block: A pilot study
Secondary ID [1] 302256 0
None
Universal Trial Number (UTN)
U1111-1250-6060
Trial acronym
PESO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
rib fractures 319035 0
Lung Function 319036 0
pain 319037 0
Condition category
Condition code
Injuries and Accidents 316989 316989 0 0
Fractures
Anaesthesiology 316990 316990 0 0
Pain management
Respiratory 316991 316991 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In patients with 3 or more acute rib fractures, patients will be randomised into either the paravertebral block catheter arm, or the erector spinae block catheter arm.

For Erector spinae block, patients will be given the patient information sheet describing the reasons for the trial; and the procedures involved. They will be given this in person by a member of the research team (doctor or nurse) who will be immediately available to answer any questions.

The equipment used will be a 16g Tuohy needle and portex catheter set. This follows local recommendations for Erector Spinae blocks and catheter insertions.

The procedure will follow standard ANZCA protocol for regional anaesthesia (PS 03) with respect to monitoring and performance of regional anaesthesia. Intravenous access will be established prior to the commencement of the block.

The block and catheter insertion will take place in the operating theatre complex, either in an operating theatre, or in the Post-Anaesthesia Care Unit (PACU), with appropriate monitoring and assistance from an anaesthetic technician or nurse.

The practitioner will be a qualified anaesthetist who is skilled and confident in performing this technique (usually minimum 20 blocks completed).

The Erector Spinae block and catheter insertion will be performed in the following manner:
The patient will be positioned in the sitting position, with the side of catheter insertion marked. If this is not possible due to significant pain, sedation or other injuries, then the patient should be positioned with assistance with the side opposite the block dependent.

The point of needle entry will be defined by both anatomical and ultrasound landmarks and should consider the number of rib fractures and the patient’s site of maximal pain. Catheter insertion should occur one to two spinal levels below the point of maximal tenderness or the mid-point of the fractured segments. Following application of 0.5% chlorhexidine paint, 1% lignocaine will be infiltrated subcutaneously and to deeper structures at the point of the anticipated needle entry.

Under ultrasound guidance the Erector Spinae complex and the transverse processes / proximal ribs should be defined. A 16 gauge needle will be introduced to the plane between the Erector Spinae complex and the transverse process. Saline will be injected down the needle to hydro-dissect the space, following which a catheter is inserted with up to 5cm of residual catheter inserted to the Erector Spinae plane. The catheter should be secured with both tissue glue and adhesive dressing to ensure the chance of inadvertent removal is reduced.

Local anaesthesia will be injected incrementally down the catheter following negative aspiration to both blood and air. This should consist of boluses of 5ml of ropivacaine 0.375% up to 20ml. An improvement in a vital capacity breath of >10% from pre-block insertion would be considered a successful block, along with decreased pain. Should the patient still fail to have an improvement in vital capacity of >10%, complain of pain or a block is not demonstrable to cold sensation at thirty minutes post catheter insertion, the procedure should be repeated.

If the patient fails to have an adequate block (as defined above) after 3 attempts (whether it's from one or multiple operators) on initial insertion, then the patient will be unblinded and offered an alternative block; and/or may be offered alternative therapy, such as a patient controlled analgesia device, with the medication and dosage at the discretion of the prescriber. This will be documented in the study results.

Post-insertion:
Nursing staff on the hospital ward will follow hospital protocols for patients receiving continuous regional analgesia which prescribes the frequency of observations and situations in which consultation with the Acute Pain Service is required. As patients will be followed by both the Acute Pain Service and study investigators due to their enrolment in a research study, patients are likely to receive closer monitoring for side-effects.

Follow up:
After catheter insertion and injection of local anaesthesia, standardised programmed intermittent bolus (PIB) infusions should be charted and established by the nursing staff in the post-anaesthesia care unit. This should consist of twenty millilitres of ropivacaine 0.2% every 2 hours. If they are >75 years old, or <60kg this will be adjusted to fifteen millilitres of ropivacaine 0.2% every 2 hours.

On subsequent review if the patient remains in significant pain, the prescription will be changed to twenty millilitres of bupivacaine 0.25% every 2 hours (or fifteen millilitres if >75 years old, or <60kg). If this is inadequate, a standard opioid patient-controlled analgesia (PCA) pump with either morphine or oxycodone can be charted. Should the patient continue to experience significant pain, and after discussion with the Acute Pain Service consultant, a ketamine infusion could be considered; or the catheter re-sited in the same treatment arm, with only the proceduralist being unblinded to perform the re-insertion.

Should a catheter at this point fail again after re-insertion, at the discretion of the acute pain service, they may be unblinded and offered an alternative block/treatment. Their data will still be used in the study, and the failure of catheter blocks will be recorded.

All patients will receive a standard oral multimodal analgesic regimen. The nature of this will be tailored to their co-morbidities, injuries (e.g. head injuries), current blood parameters (including renal function), patient allergies/adverse reactions, and other contraindications. This may include:
- Paracetamol 1g orally or intravenous, regularly every 6 hours
- Celecoxib 100mg orally, regularly every 12 hours
- Tramadol sustained release 100mg orally, regularly every 12 hours
- Morphine or oxycodone immediate release - 5-10mg orally, as required every hour
- Tramadol immediate release – 50mg orally or intravenous, as required every four hours

The continuous regional analgesic catheters will be removed or re-sited at the discretion of the Acute Pain Service when:
- they are no longer required or;
- are inadequate in providing analgesia or;
- after a maximum of 4 days post-insertion to minimise risk of infection of the regional catheter.

All patients will receive monitoring on the ward or critical care unit in keeping with the guidelines and protocols at Counties Manukau Health for patients receiving continuous regional analgesia. Adherence to the intervention will be monitored by reviewing nursing notes by the research team nurses, as well as the daily pain team review. Data will be collected daily on:
- whether block appears to still be effective (yes or no)
- dose of extra immediate-release opioid required ON TOP OF the regular simple analgesia medication prescribed above
- if the patient develops pain and the spirometry values fall below 10% change in vital capacity from pre-block readings. This will be deemed a failed block, and alternative interventions as described above will be undertaken.
Intervention code [1] 318574 0
Treatment: Other
Intervention code [2] 318800 0
Treatment: Devices
Comparator / control treatment
The Paravertebral block and catheter insertion will be the control/comparator.

As above, patients will be given the patient information sheet describing the reasons for the trial; and the procedures involved. They will be given this in person by a member of the research team (doctor or nurse) who will be immediately available to answer any questions.

The equipment used will be a 16g Tuohy needle and portex catheter set. This follows local recommendations for Erector Spinae blocks and catheter insertions.

The procedure will follow standard ANZCA protocol for regional anaesthesia (PS 03) with respect to monitoring and performance of regional anaesthesia. Intravenous access will be established prior to the commencement of the block.

The block and catheter insertion will take place in the operating theatre complex, either in an operating theatre, or in the Post-Anaesthesia Care Unit (PACU), with appropriate monitoring and assistance from an anaesthetic technician or nurse.

The practitioner will be a qualified anaesthetist who is skilled and confident in performing this technique (usually minimum 20 blocks completed).

The Paravertebral block and catheter insertion will be performed in the following manner:
The patient will be positioned in the sitting position, with the side of catheter insertion marked. If this is not possible due to significant pain, sedation or other injuries, then the patient should be positioned with assistance with the side opposite the block dependent.

The point of needle entry will be defined by both anatomical and ultrasound landmarks and should consider the number of rib fractures and the patient’s site of maximal pain. Catheter insertion should occur one to two spinal levels below the point of maximal tenderness or the mid-point of the fractured segments. Following application of 0.5% chlorhexidine paint, 1% lignocaine will be infiltrated subcutaneously and to deeper structures at the point of the anticipated needle entry.

A 16 gauge needle will be introduced under ultrasound guidance towards the paravertebral space. After final needle placement, a hanging drop technique will be used to assess for interpleural placement while the patient inhales and exhales deeply. The paravertebral catheter is then inserted, with up to 5cm of residual catheter inserted to the paravertebral space. The catheter should be secured with both tissue glue and adhesive dressing to ensure the chance of inadvertent removal is reduced.

Local anaesthesia will be injected incrementally down the catheter following negative aspiration to both blood and air. This should consist of boluses of 5ml of ropivacaine 0.375% up to 20ml. An improvement in a vital capacity breath of >10% from pre-block insertion would be considered a successful block, along with decreased pain and/or a demonstration of block to cold sensation across dermatomes. Should the patient still fail to have an improvement in vital capacity of >10%, complain of pain or a block is not demonstrable to cold sensation at thirty minutes post catheter insertion, the procedure should be repeated

If the patient fails to have an adequate block (as defined above) after 3 attempts (whether it's from one or multiple operators) on initial insertion, then the patient will be unblinded and offered an alternative block; and/or may be offered alternative therapy, such as a patient controlled analgesia device, with the medication and dosage at the discretion of the prescriber. This will be documented in the study results.

Post-insertion:
Nursing staff on the hospital ward will follow hospital protocols for patients receiving continuous regional analgesia which prescribes the frequency of observations and situations in which consultation with the Acute Pain Service is required. As patients will be followed by both the Acute Pain Service and study investigators due to their enrolment in a research study, patients are likely to receive closer monitoring for side-effects.

Follow up:
After catheter insertion and injection of local anaesthesia, standardised programmed intermittent bolus (PIB) infusions should be charted and established by the nursing staff in the post-anaesthesia care unit. This should consist of twenty millilitres of ropivacaine 0.2% every 2 hours. If they are >75 years old, or <60kg this will be adjusted to fifteen millilitres of ropivacaine 0.2% every 2 hours.

On subsequent review if the patient remains in significant pain, the prescription will be changed to twenty millilitres of bupivacaine 0.25% every 2 hours (or fifteen millilitres if >75 years old, or <60kg). If this is inadequate, a standard opioid patient-controlled analgesia (PCA) pump with either morphine or oxycodone can be charted. Should the patient continue to experience significant pain, and after discussion with the Acute Pain Service consultant, a ketamine infusion could be considered, or the catheter re-sited in the same treatment arm, with only the proceduralist being unblinded to perform the re-insertion

Should a catheter fail again after re-insertion, at the discretion of the acute pain service, they may be unblinded and offered an alternative block/treatment. Their data will still be used in the study, and the failure of catheter blocks will be recorded.

All patients will receive a standard oral multimodal analgesic regimen. The nature of this will be tailored to their co-morbidities, injuries (e.g. head injuries), current blood parameters (including renal function), patient allergies/adverse reactions, and other contraindications. This may include:
- Paracetamol 1g orally or intravenously, regularly every 6 hours
- Celecoxib 100mg orally, regularly every 12 hours
- Tramadol sustained release 100mg orally, regularly every 12 hours
- Morphine or oxycodone immediate release - 5-10mg orally, as required every hour
- Tramadol immediate release – 50mg orally or intravenously, as required every four hours

The continuous regional analgesic catheters will be removed or re-sited at the discretion of the Acute Pain Service when
- they are no longer required or;
- are inadequate in providing analgesia or;
- after a maximum of 4 days post-insertion to minimise risk of infection of the regional catheter.

All patients will receive monitoring on the ward or critical care unit in keeping with the guidelines and protocols at Counties Manukau Health for patients receiving continuous regional analgesia. Adherence to the intervention will be monitored by reviewing nursing notes by the research team nurses, as well as the daily pain team review. Data will be collected daily on:
- whether block appears to still be effective (yes or no)
- dose of extra immediate-release opioid required ON TOP OF the regular simple analgesia medication prescribed above
- if the patient develops pain and the spirometry values fall below 10% change in vital capacity from pre-block readings. This will be deemed a failed block, and alternative interventions as described above will be undertaken.

Control group
Active

Outcomes
Primary outcome [1] 325100 0
Primary outcome:
- Pulmonary function measured by portable bedside spirometry, looking at Forced Expiratory Volume for 1 second (FEV1). Recordings will be completed by Respiratory Physiotherapy staff
Timepoint [1] 325100 0
- Pre-insertion of the continuous regional analgesic catheter
- Immediately post-insertion in the post-anaesthesia care unit
- Post-insertion Day 1 at midday
- Post-insertion Day 2 at midday
Primary outcome [2] 325378 0
Pulmonary function measured by portable bedside spirometry, looking at Peak Expiratory Flow Rate (PEFR). Recordings will be completed by Respiratory Physiotherapy staff
Timepoint [2] 325378 0
- Pre-insertion of the continuous regional analgesic catheter
- Immediately post-insertion in the post-anaesthesia care unit
- Post-insertion Day 1 at midday
- Post-insertion Day 2 at midday
Primary outcome [3] 325379 0
- Pulmonary function measured by portable bedside spirometry, looking at Forced Vital Capacity (FVC). Recordings will be completed by Respiratory Physiotherapy staff
Timepoint [3] 325379 0
- Pre-insertion of the continuous regional analgesic catheter
- Immediately post-insertion in the post-anaesthesia care unit
- Post-insertion Day 1 at midday
- Post-insertion Day 2 at midday
Secondary outcome [1] 386839 0
Opioid consumption
- Opiate consumption will be converted to oral morphine equivalents as per the Australian and New Zealand College of Anaesthetists ‘Opioid Calculator’
- Intravenous consumption through patient controlled intermittent bolus or continuous infusions will be obtained from relevant hospital paper chart and oral administration via the hospital electronic dispensing database (Pyxis) which is maintained by the Hospital Pharmacy Department
Timepoint [1] 386839 0
At twelve- and twenty-four-hours post-insertion of the continuous regional catheter.
Secondary outcome [2] 386840 0
Pain scores at rest and on movements via the standard 10cm visual analogue scale. This will be assessed together as a composite outcome. This has been prospectively validated and is the gold standard method to assess acute pain
Timepoint [2] 386840 0
Immediately after insertion of regional analgesic catheter; and at twelve and twenty four hours post-catheter insertion.
Secondary outcome [3] 386841 0
Ease of catheter insertion rated by the procedural anaesthetist using visual analogue scale given to proceduralist
Timepoint [3] 386841 0
Data will be collected immediately post insertion and recorded by research nurses.
Secondary outcome [4] 387715 0
Pneumothorax Complications related to catheter insertion
Timepoint [4] 387715 0
Data will be collected by the pain service and research team daily for the duration of the catheter in situ.
Secondary outcome [5] 387716 0
Catheter related complication - hypotension. This will be gathered from the observations recorded in hospital charts.
Timepoint [5] 387716 0
Duration of catheter being in situ in patient
Secondary outcome [6] 387717 0
Catheter related complication - need for ICU intervention, as deemed by proceduralist, or medical doctor on pain round.
Timepoint [6] 387717 0
Duration of catheter in situ in patient
Secondary outcome [7] 387718 0
Duration of the infusion and date / time of catheter termination; information gathered from the hospital records/clinical notes.
Timepoint [7] 387718 0
Duration of catheter in situ in patient
Secondary outcome [8] 387719 0
Need for catheter reinsertion, as documented in the hospital records (patient's clinical notes; and/or acute pain service notes).
Timepoint [8] 387719 0
Duration of patient hospital stay where catheter intervention is deemed appropriate by medical staff
Secondary outcome [9] 387720 0
Failure of catheter re-insertion (gathered from the hospital clinical records, and/or the acute pain service notes).
Timepoint [9] 387720 0
Duration of patient hospital stay where catheter intervention is deemed appropriate by medical staff
Secondary outcome [10] 387721 0
Need for alternative block/treatment (information gathered from the hospital clinical records, and/or the acute pain service notes)
Timepoint [10] 387721 0
Duration of patient hospital stay, where catheter intervention is deemed appropriate by medical staff

Eligibility
Key inclusion criteria
Inclusion Criteria:
- Adult patients aged greater than 18 years old

- Three or more rib fractures diagnosed on either plain radiograph or computed tomography (CT) scan of the chest

- Decision by the Pain Service to insert a continuous regional analgesic catheter – defined as either:
o Paravertebral catheter
o Erector spinae plane catheter

- American Society of Anaesthesiologists Physiologic State (ASA-PS) classification of I-IV
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria:
- Patients who are unable or unwilling to offer verbal and / or written informed consent, either in person or through their proxy including those with limitations in communication where interpretation is unavailable
- Sternal or bilateral rib fractures
- Pre-existing spinal deformity which precludes the insertion of a continuous regional analgesic catheter
- Local infection or trauma at proposed site of injection
- Known allergy to the local anaesthetic agents (ropivacaine and bupivacaine) used in the study.
- Those with significant trauma outside the chest wall e.g., acute spinal fractures with or without spinal cord injury; significant pelvic or long bone fractures, severe traumatic brain injury, or abdominal visceral injuries
- Patients on anticoagulants or anti-platelets except Aspirin

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation and concealment conducted by a team member who is not involved in the surgery or patient assessment. The same team member will prepare opaque envelopes in which the intervention type is concealed. These envelopes will be opened a few minutes before attempting the regional block. This will consist of either insertion of a continuous paravertebral or erector spinae plane block as described in previous sections.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following informed consent, the patient will be randomised and allocated to one of two groups (1:1 ratio, parallel randomization) via computer-generated randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
We will make use of a Microsoft Excel spreadsheet to collate data. Statistical analysis will be completed using SPSS Version 24 for Windows. Count data will be expressed as number (percentage) and continuous data will be tested for normality using the Shapiro-Wilk test. Normally distributed data will be expressed as mean ± standard deviation, while data not meeting the criteria for normality will be represented as median with an interquartile range.

For point estimates of an incidence, a confidence interval will be calculated through the use of the Modified Wald test with the Agresti Corll correction applied. Association between factors will be tested using either the Fisher Exact test for binomial predictors or univariate regression for continuous predictors if the outcome is binomial. For continuous outcome variables we will make use of univariate regression to test for an association.

Entry criteria to the model will be a two-tailed p-value < 0.10 on the aforementioned
associative tests. The final results will be expressed as both p-values and an odds ratio with an attached confidence interval.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2021
Actual
Date of last participant enrolment
Anticipated
31/07/2021
Actual
Date of last data collection
Anticipated
31/08/2021
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 22982 0
New Zealand
State/province [1] 22982 0
Auckland

Funding & Sponsors
Funding source category [1] 306677 0
Hospital
Name [1] 306677 0
Middlemore Hospital
Country [1] 306677 0
New Zealand
Primary sponsor type
Hospital
Name
Middlemore Hospital
Address
100 Hospital Road, Otahuhu, Auckland, 2025
Country
New Zealand
Secondary sponsor category [1] 307230 0
None
Name [1] 307230 0
N/A
Address [1] 307230 0
N/A
Country [1] 307230 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306857 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 306857 0
Ethics committee country [1] 306857 0
New Zealand
Date submitted for ethics approval [1] 306857 0
10/07/2020
Approval date [1] 306857 0
05/08/2020
Ethics approval number [1] 306857 0
20/CEN/116

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

Contacts
Principal investigator
Name 105250 0
Dr Michael Hugh Ng
Address 105250 0
Department of Anaesthesia, Middlemore Hospital, 100 Hospital Road, Otahuhu, Auckland, 2025
Country 105250 0
New Zealand
Phone 105250 0
+64 21 187 8696
Fax 105250 0
Email 105250 0
michael.hugh.ng@gmail.com
Contact person for public queries
Name 105251 0
Michael Hugh Ng
Address 105251 0
Department of Anaesthesia, Middlemore Hospital, 100 Hospital Road, Otahuhu, Auckland, 2025
Country 105251 0
New Zealand
Phone 105251 0
+64 9 276 0044
Fax 105251 0
Email 105251 0
michael.ng2@middlemore.co.nz
Contact person for scientific queries
Name 105252 0
Michael Hugh Ng
Address 105252 0
Department of Anaesthesia, Middlemore Hospital, 100 Hospital Road, Otahuhu, Auckland, 2025
Country 105252 0
New Zealand
Phone 105252 0
+64 9 276 0044
Fax 105252 0
Email 105252 0
michael.ng2@middlemore.co.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only after de-indentification
When will data be available (start and end dates)?
Immediately following publication, no end date determined yet.
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator (michael.ng2@middlemore.co.nz)


What supporting documents are/will be available?

No Supporting Document Provided



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.