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Trial registered on ANZCTR


Registration number
ACTRN12618000701224
Ethics application status
Approved
Date submitted
9/04/2018
Date registered
30/04/2018
Date last updated
30/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot randomised controlled trial comparing placebo to continuous erector spinae block for patients having surgery of the torso
Scientific title
A pilot triple-masked randomised placebo-controlled trial evaluating the efficacy of continuous erector spinae block in reducing pain at 24 hours for patients having surgery of the torso.
Secondary ID [1] 294551 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Regional anaesthesia 307327 0
Condition category
Condition code
Anaesthesiology 306435 306435 0 0
Anaesthetics
Surgery 306436 306436 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Continuous erector spinae block is the intervention. Erector spinae block is a new regional anaesthesia technique of the torso. This intervention will be delivered by an anaesthetist with extensive experience in ultrasound-guided regional anaesthesia techniques (> 100 procedures) and who has performed a minimum of 10 ultrasound-guided erector spinae blocks. All procedures will be performed or observed by researcher. A training video has been produced to assist in standardising the procedure (https://www.dropbox.com/s/2iz4qz4e88zcv6p/Barrington_ErectorSpinaeBlock.mp4?dl=0). This intervention will be delivered 30 - 60 minutes preoperatively. The intervention involves injection of local anaesthetic, ropivacaine 0.5% (group L) or normal saline placebo (group P) in the plane between the erector spinae muscle and the thoracic transverse process. The needle trajectory is guided by ultrasound imaging with the transducer in longitudinal orientation so that the transverse processes are imaged in the sagittal plane and the needle is in-plane. The initial injection (0.35 mL/kg) will be followed by a postoperative infusion regimen of either local anaesthetic, ropivacaine 0.2% ( group L) or normal saline placebo (group P). This regimen will comprise every 4 hours a bolus: 15 mL if weight < 60 kg; 20 mL if weight > or equal t0 60 kg.
Intervention code [1] 300847 0
Treatment: Surgery
Comparator / control treatment
Placebo which comprises normal saline delivered into the erector spinae plane in the same volume and method as the local anaesthetic
Control group
Placebo

Outcomes
Primary outcome [1] 305449 0
Difference in average Numerical Rating Scale pain score between the 2 study groups at 24 hours, as measured as part of the Brief Pain Inventory
Timepoint [1] 305449 0
24 hours postoperatively
Primary outcome [2] 305552 0
Feasibility criterion for success is recruiting 3 or more patients per week
Timepoint [2] 305552 0
not relevant, as is a feasibility outcome
Secondary outcome [1] 345280 0
Sensory blockade at 24 hours - 80 patients, the proportion of patients with a sensory block to ice (temperature discrimination) in each study group will be compared
Timepoint [1] 345280 0
24 hours postoperatively
Secondary outcome [2] 345727 0
Quality of Recovery, QoR15 (as a patient-rated outcome)
Timepoint [2] 345727 0
24 hours postoperatively
Secondary outcome [3] 345728 0
Brief Pain Inventory, BPI short form
Timepoint [3] 345728 0
24 hours and 3 months postoperatively
Secondary outcome [4] 346152 0
Patient satisfaction (11 questions as reported previously - Ironfield et. al. Are patients satisfied after peripheral nerve blockade? Results from an International Registry of Regional Anesthesia. Reg Anesth Pain Med 2014; 39: 48-55)
Timepoint [4] 346152 0
24 hours postoperatively

Eligibility
Key inclusion criteria
Patients scheduled for the following surgery: video-assisted thoracoscopy, thoracotomy, mastectomy with and without reconstruction, axillary dissection, chest wall resection and/or reconstruction, upper abdominal laparoscopic surgery, ventral hernia repair and major lumbar/hip surgery. These surgical types are on the torso where erector spinae block is indicated based on published case reports and reported anatomical distribution of sensory blockade.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusions will comprise contraindications to the erector spinae block procedure (1. known hypersensitivity to ropivacaine or to any amide local anaesthetic; and 2. Local infection or tumour involvement at or close to the injection site), existing neuropathic pain or neurologic disorder affecting the torso, pregnancy, substance abuse; and impaired ability to complete questionnaires, communicate with the investigators or hospital staff.

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)
Sealed opaque envelopes will contain randomisation sequence, The allocation sequence and person placing group allocation into the envelopes will not be involved in implementation of study protocol or data collection. Because the trial is multicentre, some sites may need to contact the holder of the allocation schedule at the administering institution
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation, participants will be stratified according to site and surgical region/type (e.g. thoracic surgery, mastectomy).
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
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis
We estimate that we will require 34 patients per group to detect a difference in numerical rating scale for pain at 24-hours (primary outcome) of 2 (SD of 2) with 80% power. This is a similar estimate to a study of patients having mastectomy, where they included 30 patients per group to detect a difference in NRS of 1.5(SD of 1.5). There may be increased variance in this study (heterogeneous surgical population) therefore we aim to recruit 40 patients per group. This study will not be powered to detect a difference in secondary patient-rated outcomes. 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). Sensory block to ice will be treated as a binary outcome, present or not present at an individual dermatomal level. We plan to use Fisher’s exact test to compare the overall distribution of sensory block (insertion at T5 compared to at T7) and Wilcoxon rank-sum to compare the total number of segments involved and NRS pain. Statistical analyses will be performed using Stata 12.0 (StataCorp, College Station, TX, USA). A p value < 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment postcode(s) [1] 22330 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 10265 0
New Zealand
State/province [1] 10265 0
Waikato

Funding & Sponsors
Funding source category [1] 299174 0
Hospital
Name [1] 299174 0
St. Vincent's Hospital, Melbourne, Department of Anaesthesia and Acute Pain Medicine
Address [1] 299174 0
Victoria Pde, Fitzroy, 3065, VIC
Country [1] 299174 0
Australia
Primary sponsor type
Individual
Name
Michael Barrington
Address
St. Vincent's Hospital, Melbourne, Department of Anaesthesia and Acute Pain Medicine, Victoria Pde, Fitzroy, 3065, VIC
Country
Australia
Secondary sponsor category [1] 298432 0
None
Name [1] 298432 0
Address [1] 298432 0
Country [1] 298432 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300098 0
St. Vincent's Hospital, Melbourne, Human Research Ethics Committee
Ethics committee address [1] 300098 0
St. Vincent's Hospital, Melbourne, Human Research Ethics Committee, Victoria Pde, Fitzroy, 3065, VIC
Ethics committee country [1] 300098 0
Australia
Date submitted for ethics approval [1] 300098 0
20/02/2018
Approval date [1] 300098 0
10/04/2018
Ethics approval number [1] 300098 0
SERP HREC Reference Number: HREC/18/SVHM/48

Summary
Brief summary
Surgery on chest, abdomen, pelvis and hip (torso) is commonly performed worldwide. Adequate pain relief is essential for smooth recovery and avoidance of complications after surgery. Commonly, strong painkillers containing morphine or morphine like drugs (opioids) are used to treat pain following surgery. Opioids have side-effects such as drowsiness, nausea and vomiting. Furthermore, opioids can impair respiratory function, resulting in reduced oxygen in the bloodstream. Opioids are also highly addictive, and it has become apparent that when patients use these drugs to treat pain following surgery, a proportion continue to take the drugs well beyond the period that they are required to do so because of pain. In other words, the use of opioids to treat acute pain following surgery is a potential pathway to persistent use of opioids and even addiction. In the United States, a leading cause of death is opioid overdose following a legal prescription. There are signs in Australia that similar events are occurring, for example our population are increasingly being prescribed stronger longer lasting opioids and there have also been an increase in opioid-related deaths. In this research, we will be examining whether a regional anaesthesia technique called erector spinae block is effective in both reducing pain and patients’ requirements for highly addictive opioids. Erector spinae block uses local anaesthetic to block the pain and therefore it should reduce the need for opioids, however, this is technique is new and therefore should be subject to rigorous scientific evaluation. The erector spinae block uses ultrasound to guide injection of local anaesthetic between the muscle layers of the back. The nerves that supply the chest, abdomen, pelvis and hip are located between these muscles. By numbing these nerves, this technique has the potential to reduce pain after surgery on the torso. This study is a placebo-controlled randomised controlled trial and involves patients being allocated into two groups. Each group has a different treatment, erector spinae block either with local anaesthetic (active treatment) or with saline (salt water mixture, placebo). A catheter (thin plastic tube) will be inserted into the plane and regular boluses will be given up to 24 hours after the operation, with solutions administered depending on the patient allocation group. To ensure the groups are similar, each patient is allocated to a group by chance (random) before surgery takes place. The patients have an equal chance of being allocated to either the treatment group or placebo group. We plan to recruit 80 patients into the study.The main outcomes to be measured are pain score, opioid use and other outcomes that are important to the patient. These include patient-rated quality of recovery and satisfaction 24 hours after the operation. We expect that patients who received erector spinae block will have reduced pain scores and improved quality of recovery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82562 0
A/Prof Michael Barrington
Address 82562 0
Department of Anaesthesia and Acute Pain Medicine
St. Vincent's Hospital, Melbourne
PO Box 2900
Victoria Pde, Fitzroy, 3065, VIC
Australia
Country 82562 0
Australia
Phone 82562 0
+61 3 9288 4195
Fax 82562 0
Email 82562 0
michael.barrington@svha.org.au
Contact person for public queries
Name 82563 0
A/Prof Michael Barrington
Address 82563 0
Department of Anaesthesia and Acute Pain Medicine
St. Vincent's Hospital, Melbourne
PO Box 2900
Victoria Pde, Fitzroy, 3065, VIC
Australia
Country 82563 0
Australia
Phone 82563 0
+61 3 9288 4195
Fax 82563 0
Email 82563 0
michael.barrington@svha.org.au
Contact person for scientific queries
Name 82564 0
A/Prof Michael Barrington
Address 82564 0
Department of Anaesthesia and Acute Pain Medicine
St. Vincent's Hospital, Melbourne
PO Box 2900
Victoria Pde, Fitzroy, 3065, VIC
Australia
Country 82564 0
Australia
Phone 82564 0
+-61 3 9288 4195
Fax 82564 0
Email 82564 0
michael.barrington@svha.org.au

No information has been provided regarding IPD availability
Summary results
No Results