Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001334291
Ethics application status
Approved
Date submitted
27/07/2018
Date registered
8/08/2018
Date last updated
4/06/2019
Date data sharing statement initially provided
18/02/2019
Date results provided
18/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of efficacy of erector spinae plane block performed with two different bupivacaine concentrations on postoperative analgesia after mastectomy surgery
Scientific title
Evaluation of efficacy of erector spinae plane block performed with two different bupivacaine concentrations on postoperative analgesia of adult female patients after mastectomy surgery
Secondary ID [1] 295674 0
None
Universal Trial Number (UTN)
U1111-1218-1981
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast cancer 309031 0
postoperative pain 309032 0
Condition category
Condition code
Cancer 307925 307925 0 0
Breast
Anaesthesiology 307926 307926 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the operating room (OR), all of the patients will receive a standard monitoring including electrocardiography, non-invasive blood pressure, peripheral oxygen saturation and bi-spectral index monitoring. After the placement of a 22-gauge intraveous line, 15 ml kg-1 isotonic saline infusion will be started. All patients will receive intravenous 0.05 midazolam for sedation. Then the patients will randomly divided into two groups based on a computerized randomization table created by a researcher who will not involve in the study. There will be two anesthesiologists in the OR. For each randomized patient, the first anesthesiologist will take the corresponding sealed envelope from a folder, which indicates the treatment assigned to the patient, while the second anesthesiologist will be blind to the group allocations. The first anesthesiologist will prepare the drug solutions for use in the study (0.25% bupivacaine or 0.375% bupivacaine solution) in two identical 20 ml syringes and a 10 ml syringe of isotonic saline for hydrodissection and pass the labeled syringes to the blinded anesthesiologist. And the patients will be placed in sitting position. In the first group (Group High ESP), the second anesthesiologist will locate the ultrasound probe in longitudinal orientation at the level of T4 spinous process and then place 3 cm laterally from the midline. The ultrasound landmarks, T4 transverse process and the overlying trapezius, rhomboideus and erector spinae muscle, will be identified. Under aseptic conditions, a 80 mm 21-gauge block needle will be inserted in-plane at an angle of 30-40 degrees in cranial-to-caudal direction until the tip contacts the T4 transverse process. After the hydrodissection with 3 mL of isotonic saline solution confirmes correct needle tip position, the anesthesiologist will inject 20 mL of 0.375% bupivacaine deep into the erector spinae muscle. The block procedure will take approximately 5-10 minutes and then the anesthesiologists will start induction of anesthesia with intravenous propofol, fentanyl and rocuronium bromide.
Intervention code [1] 301990 0
Treatment: Drugs
Comparator / control treatment
In the second group (Group Low ESP), the patients will receive the same US-ESP block with 20 ml of 0.25% bupivacaine.
Control group
Active

Outcomes
Primary outcome [1] 306899 0
To assess the postoperative opioid consumption in the first 24 hours by calculating the tramadol dose administered by patient controlled analgesia device
Timepoint [1] 306899 0
Postoperative 24th hour
Secondary outcome [1] 350050 0
To assess pain scores of the patients by using 11-points numerical rating scale (NRS) at the postoperative 15th minute, 30th minute, 60th minute (secondary outcome), 12th hour and 24th hour
Timepoint [1] 350050 0
Postoperative 15th minute, 30th minute, 60th minute (secondary outcome), 12th hour and 24th hour
Secondary outcome [2] 350051 0
To assess intraoperative fentanyl consumption by using data-linkage to surgical records
Timepoint [2] 350051 0
At the end of each surgery

Eligibility
Key inclusion criteria
Patients with ASA physical status I-III, between 18-70 years old ,scheduled for an elective unilateral radical mastectomy with axillary lymph node dissection
Minimum age
18 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
The patients with coagulation disorder, known allergy to local anesthetics, infection at the injection site, history of previous mastectomy, advanced hepatic or renal failure or chronic opioid consumption

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will conduct the statistical analysis using the software Statistical Package for Social Science (SPSS), version 17 (made by SPSS Incorporated, located in Chicago, Illinois, USA).
Values will be expressed as mean±standard deviation or as percentages. The groups will be compared in parametric parameters using independent samples T-test and in non-parametric parameters using Mann-Whitney U test. A p value < 0.05 will be accepted statistically significant. Sample size of the study was calculated by G*Power program (v3.1.9) based on a preliminary study with 15 patients in each group. At least 20% reduction in tramadol consumption at the postoperative 24th hour was accepted as clinically significant. The mean tramadol consumptions were 196.6±29.38 mg in Low ESP group and it was 142.6±28.34 mg in High ESP group. Assuming alpha=0.01 (two-tailed) with a power of 0.90, at least 18 participants were needed per each group. Considering possible drop-outs, we decided to include 21 patients in each group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/08/2018
Actual
13/08/2018
Date of last participant enrolment
Anticipated
27/08/2018
Actual
10/09/2018
Date of last data collection
Anticipated
28/08/2018
Actual
11/09/2018
Sample size
Target
42
Accrual to date
Final
42
Recruitment outside Australia
Country [1] 10688 0
Turkey
State/province [1] 10688 0
Mugla

Funding & Sponsors
Funding source category [1] 300257 0
Hospital
Name [1] 300257 0
Mugla Sitki Koçman University Training and Research Hospital
Country [1] 300257 0
Turkey
Primary sponsor type
Individual
Name
Basak ALTIPARMAK
Address
Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 Mentese/MUGLA
Country
Turkey
Secondary sponsor category [1] 299680 0
None
Name [1] 299680 0
Address [1] 299680 0
Country [1] 299680 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301077 0
Mugla Sitki Koçman University Training and Research Hospital Institutional Ethics Committee
Ethics committee address [1] 301077 0
Ethics committee country [1] 301077 0
Turkey
Date submitted for ethics approval [1] 301077 0
09/08/2018
Approval date [1] 301077 0
10/08/2018
Ethics approval number [1] 301077 0
02-07

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

Contacts
Principal investigator
Name 85802 0
Dr Basak ALTIPARMAK
Address 85802 0
Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 (postcode) Mentese/MUGLA
Country 85802 0
Turkey
Phone 85802 0
+905326726533
Fax 85802 0
Email 85802 0
[email protected]
Contact person for public queries
Name 85803 0
Basak ALTIPARMAK
Address 85803 0
Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 (postcode) Mentese/MUGLA
Country 85803 0
Turkey
Phone 85803 0
+905326726533
Fax 85803 0
Email 85803 0
[email protected]
Contact person for scientific queries
Name 85804 0
Basak ALTIPARMAK
Address 85804 0
Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 (postcode) Mentese/MUGLA
Country 85804 0
Turkey
Phone 85804 0
+905326726533
Fax 85804 0
Email 85804 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, and ending 1 year following main results publication
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator


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
SourceTitleYear of PublicationDOI
EmbaseComparison of the efficacy of erector spinae plane block performed with different concentrations of bupivacaine on postoperative analgesia after mastectomy surgery: Ramdomized, prospective, double blinded trial.2019https://dx.doi.org/10.1186/s12871-019-0700-3
N.B. These documents automatically identified may not have been verified by the study sponsor.