Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000080921
Ethics application status
Approved
Date submitted
9/12/2019
Date registered
30/01/2020
Date last updated
15/02/2021
Date data sharing statement initially provided
30/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A Double-Blinded, Randomized, Controlled Trial to Test the Efficacy of Continuous Ultrasound Guided Erector Spinae Block on Lung Function for Rib Fracture Related Pain
Scientific title
A Double-Blinded, Randomized, Controlled Trial to Test the Efficacy of Continuous Ultrasound Guided Erector Spinae Block on Respiratory Function for Rib Fracture Related Pain
Secondary ID [1] 298869 0
ANZCA Reg Key: N20/005XX
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
rib fracture 313822 0
pain 313823 0
Condition category
Condition code
Anaesthesiology 312228 312228 0 0
Pain management
Injuries and Accidents 313881 313881 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: The interventional treatment arm group consisting of 30 patients will have an ultrasound guided continuous erector spinae plane (ESP) catheter placed at the midpoint vertebral level of the affected fractured rib. A high linear (or curvilinear probe in morbidly obese patients) frequency transducer will be held in a parasagittal plane at the centre of the pain source. Next, the transverse process at the vertebral level of the middle fractured rib will be identified with the overlying erector spinae muscle. Other important sonoanatomical landmarks are the skin, subcutaneous tissue, trapezius muscle and the rhomboid muscle, which tapers off below the T5/6 region. Under strict aseptic conditions, an E-Catheter plus 20G with stylet and 15mm extended tip / indwelling cannula 18G x 75mm (3") / SonoPlex 21G x 94mm (3 2/3") will be directed from the short edge of the ultrasound probe either in a cranio-caudal direction or caudo-cranial direction depending on logistics and fracture location into the erector spinae plane, which is the fascial plane between the anterior border of the erector spinae muscle that abut the posterior margin of the relevant transverse process. Once contact to bone is established both in a tactile fashion as well as visible on live imaging. A bolus dose of 0.35 mls/kg of 0.5% Ropivacaine will be injected into the plane and the successful endpoint in proper needle positioning will be a lifting off the erector spinae muscle from the transverse process.The continuous erector spinae block will be maintained with strict programmable bolus dosing of 20 mls of 0.2% Ropivaine every 4 hours for 24 hrs. In addition, breakthrough pain will be treated with systemic opioids via patient controlled analgesia (PCA) + regular Paracetamol

Arm 2: The control group will have a catheter placed into the exact same method and into the same myofascial compartment as the study group, with the only difference being, that placebo (normal saline) shall be injected into the plane with the exact same volume and under the exact same regime as in the study group.

The ESP catheter will be inserted by a dedicated group of anesthesiologists with extensive experience in regional anaesthesia and analgesia single shot and continous catheter techniques

" Under strict aseptic conditions, an 18 G indwelling catheter x 75 mm ( with a 21 G x 94 mm SonoPlex cannula) will be directed from the short edge of the ultrasound probe either in a cranio-caudal direction or caudo-cranial direction depending on logistics and fracture location into the erector spinae plane, which is the fascial plane between the anterior border of the erector spinae muscle that abut the posterior margin of the relevant transverse process. A bolus of 0.35 ml/kg of 0.5% Ropivacaine will be injected into the plane and the successful endpoint in proper needle positioning will be a lifting off the erector spinae muscle from the transverse process. The Sonoplex cannula will be removed and an 18 G x 75 mm E- Cath Plus will be inserted via the indwelling cannula at a predefined length (15 mm protruding tip of E-Cath past the indwelling cannula).
Intervention code [1] 315133 0
Treatment: Other
Comparator / control treatment
Control Group: The control group will have a catheter placed into the exact same method and into the exact same myofascial compartment as the study group, with the only difference being, that placebo (normal saline) shall be injected into the plane with the exact same volume and under the exact same regime as in the study group. The control group will receive multi-modal analgesia just like the interventional group ( PCA + regular Paracetamol)
Control group
Placebo

Outcomes
Primary outcome [1] 321108 0
Mean Difference in portable spirometer values predictive of pulmonary function as assessed with inspiratory capacity (inspiratory reserve volume + tidal volume) at baseline prior to intervention and at 24 hrs.
Timepoint [1] 321108 0
24 hours post ESP insertion
Secondary outcome [1] 374015 0
Mean Difference in portable spirometer values predictive of pulmonary function as assessed with inspiratory capacity (inspiratory reserve volume + tidal volume) at baseline prior to intervention and at 2 hrs.
Timepoint [1] 374015 0
2 hours after ESP insertion
Secondary outcome [2] 374017 0
Nausea and vomiting on each subsequent day for 24 hours ( composite) patient- reported
Timepoint [2] 374017 0
24 hours hours post ESP insertion
Secondary outcome [3] 374018 0
Opioid dose for each 24 hour period following the intervention as assessed by the total of Patient controlled analgesia device for 24 hours
Timepoint [3] 374018 0
24 hours
Secondary outcome [4] 374019 0
Quality of Recovery, QoR-15 at baseline pre ESP and 24 hrs. post intervention
Timepoint [4] 374019 0
at baseline pre ESP and 24 hours post intervention
Secondary outcome [5] 374020 0
Hospital length of stay (as assessed by hospital records + data linkage to electronic medical records) at discharge
Timepoint [5] 374020 0
upon discharge from hospital
Secondary outcome [6] 374021 0
Incidence of adverse Effects, i.e. Infection at Catheter Site, Pneumothorax, Local Anaesthetic Toxicity each 24 hrs. for up to 7 days post intervention assessed as per clinical review by the Acute Pain Service ( APS)
Timepoint [6] 374021 0
Day 1- 7 post intervention
Secondary outcome [7] 377924 0
Difference in meaningful important Verbal Numerical Rating Scale (VRNS) pain score both at rest and on deep breathing at baseline prior to intervention and at 24 hrs post intervention
Timepoint [7] 377924 0
VNRS at baseline pre ESP and 24 hours intervention

Eligibility
Key inclusion criteria
Patients aged above the age of 18
3 or more unilateral contiguous rib fractures,
Blunt Chest Trauma, Lung contusions, flail chest
Patients who are deemed to be eligible for a regional continuous catheter technique
by the treating lead physician of the Acute Pain Service
Patients able to communicate pain scores
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Bilateral Chest Trauma
Intubated Patients
Traumatic Brain Injury, altered mental status, impaired ability to complete questionnaires or communicate
Sensitivity to local anaesthetic drugs
Infection or Tumour at the site of procedure
Coagulaopathy
Pregnancy
Healthy Volunteers
Admission to hospital for more than 72 hours
Any previous form of regional anesthesia performed on the Patient
History of chronic pain/chronic opioid therapy

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)
Computer generated randomization sequence – sealed opaque envelopes that contain a card with the computer generated allocation number (1= ESP, 2= ESP Placebo). The envelopes will be prepared by a third party (clinical trial pharmacist) who will take no further part in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomization sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
We estimate that 22 patients are required in each treatment arm to detect a clinically significant difference in spirometer volumes before and after insertion of erector spinae catheter.
The sample size calculation is based on a recently published retrospective study] [1] , which demonstrated that provision of ESP blockade in rib fracture patients improved spirometer volumes at baseline from 784 (694) to 1375 (667) ml (p < 0.01) during the first 24 h following erector spinae plane blockade.
Using a significance level of alpha = 0.05 (two sided), power of 0.8 and the mean effect sizes of 780 and 1350 mls with a standard deviation of 660, a sample size of 22 was estimated for a two-sample comparison of means. Taking into account drop outs (losses to follow-up) and improve clinical significance, we consider 30 patients per group appropriate. Data will be presented as median and interquartile range (IQR) or with mean and SD as appropriate. Normality of distribution will be tested with histograms and Q-Q plots. Categorical variables will be presented as frequency (percentages). Comparison of categorical baseline characteristics and between group differences for the presence of infection at the catheter site, pneumothorax, local anaesthetic toxicity are analysed using chi square testing or Fisher’s exact test where appropriate. Wilcoxon 2-sample test is going to be used to evaluate between group differences for pain scores at other time points.

[1] ] Adhikary SD, Liu WM, Fuller E, et al. The effect of erector spinae plane block on respiratory and analgesic outcomes in multiple rib fractures: a retrospective cohort study. Anaesthesia. 2019 Feb 10. doi: 10.1111/anae.14579. [Epub ahead of print]

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/02/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 303415 0
Other Collaborative groups
Name [1] 303415 0
Australian and New Zealand College of Anaesthetists
Country [1] 303415 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australian and New Zealand College of Anaesthetists
Address
630 St.Kilda Rd, Mel 3004 Vic
Country
Australia
Secondary sponsor category [1] 303464 0
Hospital
Name [1] 303464 0
Pain Research Fund Alfred Health
Address [1] 303464 0
630 St.Kilda Rd, Mel 3004 Vic
Country [1] 303464 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303945 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 303945 0
Ethics committee country [1] 303945 0
Australia
Date submitted for ethics approval [1] 303945 0
20/11/2019
Approval date [1] 303945 0
18/12/2019
Ethics approval number [1] 303945 0

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

Contacts
Principal investigator
Name 95334 0
Dr Mir Wais Sekandarzad
Address 95334 0
Alfred Hospital
Department of Anesthesiology and Perioperative Medicine
55 Commercial Road
Melbourne 3004 Vic
Country 95334 0
Australia
Phone 95334 0
+61 3 9076 3707
Fax 95334 0
Email 95334 0
[email protected]
Contact person for public queries
Name 95335 0
Mir Wais Sekandarzad
Address 95335 0
Alfred Hospital
Department of Anesthesiology and Perioperative Medicine
55 Commercial Road
Melbourne 3004 Vic
Country 95335 0
Australia
Phone 95335 0
+61 3 9076 3707
Fax 95335 0
Email 95335 0
[email protected]
Contact person for scientific queries
Name 95336 0
Mir Wais Sekandarzad
Address 95336 0
Alfred Hospital
Department of Anesthesiology and Perioperative Medicine
55 Commercial Road
Melbourne 3004 Vic
Country 95336 0
Australia
Phone 95336 0
+61 3 9076 3707
Fax 95336 0
Email 95336 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethcis requirement


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.