Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000879167
Ethics application status
Approved
Date submitted
20/05/2019
Date registered
20/06/2019
Date last updated
18/09/2019
Date data sharing statement initially provided
20/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of ultrasound-guided rhomboid intercostal nerve block for postoperative analgesia in breast cancer surgery: A prospective, randomized, controlled trial
Scientific title
Evaluation of ultrasound-guided rhomboid intercostal nerve block for postoperative analgesia of female patients undergoing breast cancer surgery: A prospective, randomized, controlled trial
Secondary ID [1] 298282 0
Nil known
Universal Trial Number (UTN)
U1111-1233-7145
Trial acronym
RIBT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast cancer 312899 0
postoperative pain 312900 0
Condition category
Condition code
Cancer 311388 311388 0 0
Breast
Anaesthesiology 311389 311389 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the first group (Group R), patients will be placed in lateral decubit position with the involved breast lying superiorly. The ipsilateral arm will be adducted across the chest. A rhomboid intercostal block will be performed by the anesthesiologist. A high-frequency (6–12 MHz) linear ultrasound probe will be placed medial to the medial border of the scapula. The ultrasound landmarks, trapezius muscle, rhomboid muscle, intercostal muscles, pleura and lung will be identified. Under aseptic conditions, an 80- mm 21-gauge needle will be inserted at the level of T5. A single injection of 30 ml of 0.25% bupivacaine will be applied into the interfascial plane between the rhomboid major and intercostal muscles. All patients will receive intravenous ondansetron 4 mg, dexamethasone 8 mg and dexketoprofen trometamol 50 mg for postoperative nausea prophylaxis 15 min before the end of the surgery. At the end of the operation, all patients will receive intravenous tramadol 1 mg kg-1 for postoperative analgesia.
Intervention code [1] 314520 0
Treatment: Other
Intervention code [2] 314747 0
Treatment: Drugs
Comparator / control treatment
In the control group (Group C), patients will receive intravenous 1 mg kg-1 tramadol and no block intervention will be performed. All patients will receive iv ondansetron 4 mg, dexamethasone 8 mg and dexketoprofen trometamol 50 mg intraoperatively for postoperative nausea prophylaxis and perioperative analgesia.
Control group
Active

Outcomes
Primary outcome [1] 321441 0
quality of recovery levels between groups by using 40-point QoR-40 questionnaire
Timepoint [1] 321441 0
At the postoperative 24th hour
Secondary outcome [1] 370576 0
Postoperative pain scores between groups by using 11-points Numerical Rating Scale scores
Timepoint [1] 370576 0
At the postoperative 15th min and 30th min, 1st h (secondary time-point), 2nd h, 6th h, 12th h, and 24th h
Secondary outcome [2] 371525 0
rescue analgesic consumptions between groups as assessed by data linkage to medical records
Timepoint [2] 371525 0
at the postoperative 24th hour
Secondary outcome [3] 374953 0
Total postoperative morphine consumption in the first 24 hour. Morphine consumption will be calculated directly checking the morphine delivery times recorded on patient-controlled-analgesia devise.
Timepoint [3] 374953 0
At the postoperative 24th hour

Eligibility
Key inclusion criteria
Patients between 18-70 years old, with American Society of Anesthesiologists (ASA) physical status I-II, and scheduled for an elective unilateral mastectomy surgery with sentinel node biopsy and Modified Radical Mastectomy surgery with axillary lymph node dissection.
Minimum age
18 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with coagulation disorder, chronic opioid use, psychologic disorder, known allergy to study drugs, history of previous mastectomy or other thoracic surgery, body mass index >? 35 kg m2, inability to use patient-controlled analgesia (PCA) device and surgical time longer than 150 minutes.

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
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 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
The statistical analysis will be conducted by using the NCSS software (Number Cruncher Statistical System) 2007 (Kaysville, Utah, USA). Descriptive variables will be assessed using statistical methods (mean, median, minimum-maximum, standard deviation, ratio), and the t-test will be used for the comparison of parametric variables with normal distribution between the two groups. For the comparison of parametric variables without normal distribution, the Mann- Whitney U test will be used. Pearson’s Chi-square test will be performed for the comparison of ratios, and categorical variables will be compared using Fisher’s exact test. A p value < 0.05 will be accepted as statistically significant.
For the comparison of variables with normal distribution within the groups, the repeated measures test will be used and the post-hoc test with Bonferroni correction will be performed for the evaluation of binary comparisons. For the comparison of variables without normal distribution within the groups, the Friedman test will be used and Wilcoxon’s signed-ranks test will be performed for the evaluation of binary comparisons.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/06/2019
Actual
21/06/2019
Date of last participant enrolment
Anticipated
1/08/2019
Actual
16/08/2019
Date of last data collection
Anticipated
2/08/2019
Actual
17/08/2019
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 21497 0
Turkey
State/province [1] 21497 0
Mugla

Funding & Sponsors
Funding source category [1] 302824 0
Hospital
Name [1] 302824 0
Mugla Sitki Koçman University Training and Research Hospital
Country [1] 302824 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] 302772 0
None
Name [1] 302772 0
Address [1] 302772 0
Country [1] 302772 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303406 0
Mugla Sitki Koçman University Training and Research Hospital Institutional Ethics Committee
Ethics committee address [1] 303406 0
Ethics committee country [1] 303406 0
Turkey
Date submitted for ethics approval [1] 303406 0
07/06/2019
Approval date [1] 303406 0
13/06/2019
Ethics approval number [1] 303406 0
Decision number A-VI

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

Contacts
Principal investigator
Name 93566 0
Dr Basak ALTIPARMAK
Address 93566 0
Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 (postcode) Mentese/MUGLA
Country 93566 0
Turkey
Phone 93566 0
+905326726533
Fax 93566 0
Email 93566 0
basak_ugurlu@yahoo.com
Contact person for public queries
Name 93567 0
Basak ALTIPARMAK
Address 93567 0
Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 (postcode) Mentese/MUGLA
Country 93567 0
Turkey
Phone 93567 0
+905326726533
Fax 93567 0
Email 93567 0
basak_ugurlu@yahoo.com
Contact person for scientific queries
Name 93568 0
Basak ALTIPARMAK
Address 93568 0
Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 (postcode) Mentese/MUGLA
Country 93568 0
Turkey
Phone 93568 0
+905326726533
Fax 93568 0
Email 93568 0
basak_ugurlu@yahoo.com

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, ending 1 year following main results publication
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4917Statistical analysis plan  basakugurlu@me.com
4918Ethical approval  basakugurlu@me.com



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.