Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001002279
Ethics application status
Approved
Date submitted
11/06/2018
Date registered
14/06/2018
Date last updated
4/06/2019
Date data sharing statement initially provided
4/06/2019
Date results information initially provided
4/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of the effects of modified pectoral nerve block and erector spinae plane block on postoperative pain scores and opioid consumption after radical mastectomy
Scientific title
Comparison of the effects of modified pectoral nerve block and erector spinae plane block on postoperative pain scores and opioid consumption of adult female patients after radical mastectomy
Secondary ID [1] 295161 0
Nil known
Universal Trial Number (UTN)
U1111-1215-5130
Trial acronym
P-ESP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast cancer 308277 0
postoperative pain 308278 0
Condition category
Condition code
Cancer 307288 307288 0 0
Breast
Anaesthesiology 307289 307289 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the operating room, all of the patients will receive a standard monitoring including electrocardiography, non-invasive blood pressure, peripheral oxygen saturation and bi-spectral index monitoring. An anesthesiologist will perform anesthesia inductions with intravenous 2-3 mg kg-1 propofol, 1 mcg kg-1 fentanyl and 0.6 mg kg-1 rocuronium bromide. After each patient's BIS score decreases to 40–60, endotracheal intubation will be performed.
Immediately after intubation, the patients in the first group (Group ESP) will be placed in lateral decubitus position. The anesthesiologist of the operating room will locate a high-frequency linear ultrasound probe in longitudinal orientation at the level of T4 spinous process and then place 3 cm laterally from the midline from the midline to the side of the surgery. The ultrasound landmark T4 transverse process will be identified. Under aseptic conditions, the anesthesiologist will insert a 80 mm 21-gauge block needle in-plane at an angle of 30-40 degrees in cranial-to-caudal direction until the tip contact the T4 transverse process. After the hydrodissection with 2-3 mL of isotonic saline solution confirms correct needle tip position, 20 mL of 0.25% bupivacaine will be injected in the interfascial plane between rhomboideus major and erector spinae muscle. All of the patients will receive 4-6% end-tidal desflurane in the 3 lt of 40% O2 and 60% N2O for maintenance of anesthesia. The minimum alveolar concentration of desflurane will be targeted to reach a BIS value between 40-60. At the end of the operation, postoperative analgesia will be maintained with tramadol infusion by using a patient controlled analgesia (PCA) device in all of the patients. The PCA device will administer 20 mg hour-1Tramadol as infusion, 10 mg bolus dose with a 15 minute lock-time.
Intervention code [1] 301504 0
Treatment: Surgery
Comparator / control treatment
After induction of anesthesia, the patients in control group will receive an ultrasound-guided modified PECS block. A high-frequency linear ultrasound probe will be located below the lateral third of the clavicle while the patients are in supine position with the ipsilateral upper limb abducted 90 degree. After the axillary artery and vein are indentified, the probe will be moved inferolaterally until the pectoralis major, pectoralis minor and serratus anterior muscles are seen in one plane. A 80 mm 21-gauge needle will be inserted in plane view of the ultrasound probe. When the needle reaches to the interfascial plane between the pectoralis major and minor muscles, 10 ml of 0.25% bupivacaine will be administered. Then the probe will be moved towards axilla, and when serratus anterior is identified above the third, and fourth ribs, 20 mL of bupivacaine 0.25% will be administered above the serratus anterior muscle.
Control group
Active

Outcomes
Primary outcome [1] 306256 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] 306256 0
Postoperative 24th hour
Secondary outcome [1] 347994 0
To assess intraoperative fentanyl consumption by using data-linkage to surgical records
Timepoint [1] 347994 0
At the end of each surgery.
Secondary outcome [2] 350659 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, 120th minute (secondary time-point), 12th hour and 24th hour
Timepoint [2] 350659 0
at the postoperative 15th minute, 30th minute, 60th minute, 120th minute (secondary time-point), 12th hour and 24th hour

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 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 considering the difference between postoperative tramadol consumptions of the groups. The mean tramadol consumptions were 128,66 mg in PECS group and 203,33 mg in ESP group. By using these data, we calculated the effect size as W=2,534 and there should be at least 7 patients in each group to provide 90% power with alpha=0.01.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/06/2018
Actual
18/06/2018
Date of last participant enrolment
Anticipated
29/06/2018
Actual
23/07/2018
Date of last data collection
Anticipated
30/06/2018
Actual
24/07/2018
Sample size
Target
30
Accrual to date
Final
38
Recruitment outside Australia
Country [1] 10546 0
Turkey
State/province [1] 10546 0
Mugla

Funding & Sponsors
Funding source category [1] 299750 0
Hospital
Name [1] 299750 0
Mugla Sitki Koçman University Training and Research Hospital
Country [1] 299750 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] 299089 0
None
Name [1] 299089 0
Address [1] 299089 0
Country [1] 299089 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300640 0
Mugla Sitki Koçman University Training and Research Hospital Institutional Ethics Committee
Ethics committee address [1] 300640 0
Mugla Sitki Koçman University Training and Research Hospital, Marmaris Yolu üzeri, M Kapi Karsisi, 48000 Mugla
Ethics committee country [1] 300640 0
Turkey
Date submitted for ethics approval [1] 300640 0
12/06/2018
Approval date [1] 300640 0
14/06/2018
Ethics approval number [1] 300640 0
Decision number: XII

Summary
Brief summary
Our primary aims are to compare the effects of ESP and PECS block on postoperative pain scores and opioid consumptions after mastectomy surgery. Our hypothesis is that ESP will reduce postoperative pain scores and opioid consumption of the patients more significantly than PECS block. Our secondary aims is to compare the intraoperative fentanyl need of the groups. Our hypothesis is that the fentanyl need in ESP group will be lower than PECS group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84306 0
Dr Basak ALTIPARMAK
Address 84306 0
Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 (postcode) Mentese/MUGLA
Country 84306 0
Turkey
Phone 84306 0
+905326726533
Fax 84306 0
Email 84306 0
[email protected]
Contact person for public queries
Name 84307 0
Dr Basak ALTIPARMAK
Address 84307 0
Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 (postcode) Mentese/MUGLA
Country 84307 0
Turkey
Phone 84307 0
+905326726533
Fax 84307 0
Email 84307 0
[email protected]
Contact person for scientific queries
Name 84308 0
Dr Basak ALTIPARMAK
Address 84308 0
Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 (postcode) Mentese/MUGLA
Country 84308 0
Turkey
Phone 84308 0
+905326726533
Fax 84308 0
Email 84308 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)?
Between November 2018 (online publication date of the article) and November 2019
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
No additional documents have been identified.