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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Regional anaesthesia

Condition category

Condition code

Anaesthesiology

Anaesthetics

Surgery

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]

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]

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]

24 hours postoperatively

Primary outcome [2]

Feasibility criterion for success is recruiting 3 or more patients per week

Timepoint [2]

not relevant, as is a feasibility outcome

Secondary outcome [1]

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]

24 hours postoperatively

Secondary outcome [2]

Quality of Recovery, QoR15 (as a patient-rated outcome)

Timepoint [2]

24 hours postoperatively

Secondary outcome [3]

Brief Pain Inventory, BPI short form

Timepoint [3]

24 hours and 3 months postoperatively

Secondary outcome [4]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

15/05/2018

Actual

Date of last participant enrolment

Anticipated

2/08/2019

Actual

Date of last data collection

Anticipated

2/11/2019

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD,VIC

Recruitment postcode(s) [1]

3065 - Fitzroy

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Waikato

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

St. Vincent's Hospital, Melbourne, Department of Anaesthesia and Acute Pain Medicine

Address [1]

Victoria Pde, Fitzroy, 3065, VIC

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St. Vincent's Hospital, Melbourne, Human Research Ethics Committee

Ethics committee address [1]

St. Vincent's Hospital, Melbourne, Human Research Ethics Committee, Victoria Pde, Fitzroy, 3065, VIC

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/02/2018

Approval date [1]

10/04/2018

Ethics approval number [1]

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

A/Prof Michael Barrington

Address

Department of Anaesthesia and Acute Pain Medicine
St. Vincent's Hospital, Melbourne
PO Box 2900
Victoria Pde, Fitzroy, 3065, VIC
Australia

Country

Australia

Phone

+61 3 9288 4195

Fax

michael.barrington@svha.org.au

Contact person for public queries

Name

Michael Barrington

Address

Department of Anaesthesia and Acute Pain Medicine
St. Vincent's Hospital, Melbourne
PO Box 2900
Victoria Pde, Fitzroy, 3065, VIC
Australia

Country

Australia

Phone

+61 3 9288 4195

Fax

michael.barrington@svha.org.au

Contact person for scientific queries

Name

Michael Barrington

Address

Department of Anaesthesia and Acute Pain Medicine
St. Vincent's Hospital, Melbourne
PO Box 2900
Victoria Pde, Fitzroy, 3065, VIC
Australia

Country

Australia

Phone

+-61 3 9288 4195

Fax

michael.barrington@svha.org.au

No information has been provided regarding IPD availability

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

Source	Title	Year of Publication	DOI
Embase	Reply to Dr Chin et al.	2018	https://dx.doi.org/10.1097/AAP.0000000000000862
Embase	A pilot randomized-controlled trial evaluating the erector spinae plane block in thoracic and breast surgery.	2020	https://dx.doi.org/10.1007/s12630-020-01759-5

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added automatically