Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001078246
Ethics application status
Approved
Date submitted
18/06/2018
Date registered
28/06/2018
Date last updated
22/11/2018
Date data sharing statement initially provided
19/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Ultrasound-guided erector spinae plane block versus oblique subcostal transversus abdominis plane block for postoperative analgesia in laparoscopic cholecystectomy: Randomized controlled double blinded trial
Scientific title
Ultrasound-guided erector spinae plane block versus oblique subcostal transversus abdominis plane block for postoperative analgesia of adult patients in laparoscopic cholecystectomy: Randomized controlled double blinded trial
Secondary ID [1] 295238 0
Nil known
Universal Trial Number (UTN)
U1111-1215-8533
Trial acronym
UG-ESP vs UG-TAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cholelithiasis 308405 0
postoperative pain 308406 0
Condition category
Condition code
Anaesthesiology 307397 307397 0 0
Pain management
Oral and Gastrointestinal 307428 307428 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

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. Intravenous 4 mg ondansetron will be applied for postoperative nausea and intravenous 50 mg dexketoprofen trometamol will be applied as a part of multimodal analgesia. 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 T7 spinous process and then place 3 cm laterally from the midline. The ultrasound landmarks T7 transverse process and overlying erector spinae muscle 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 T7 transverse process. After the hydrodissection with 2-3 mL of isotonic saline solution confirms correct needle tip position, 20 mL of 0.375% bupivacaine will be injected deep into the erector spinae muscle. The same procedure will be performed to the contralateral side. 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 intravenous patient-controlled analgesia (PCA) device in all of the patients. The PCA device will administer 10 mg tramadol as bolus dose with a 15 minute lock-time, and no basal infusion.
Intervention code [1] 301574 0
Treatment: Surgery
Comparator / control treatment
In the second group, the patients will receive oblique subcostal TAP block in supine position immediately after the endotracheal intubation. The anesthesiologist of the operating room will place the ultrasound probe obliquely on the upper abdominal wall along the subcostal margin near the xiphisternum of the sternum in the midline of the abdomen. The landmarks, rectus abdominis muscle and underlying transversus abdominis muscle, will be identified near the costal margin and xyphoid. The probe then will be moved laterally, first the aponeurosis of external, internal oblique and transversus abdominis will be seen than the probe will be moved laterally until the transversus abdominis muscle is identified. The needle will be directed toward the transversus abdominis fascia. Injection of 20 ml Bupivacaine 0.375% will be done between internal obliquus and transversus abdominis muscles along the subcostal line. The same procedure will repeated to the contralateral side.
Control group
Active

Outcomes
Primary outcome [1] 306368 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] 306368 0
Postoperative 24th hour
Secondary outcome [1] 348272 0
To assess intraoperative fentanyl consumption by using data-linkage to surgical records
Timepoint [1] 348272 0
At the end of each surgery
Secondary outcome [2] 352964 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 (primary time-point), 120th min, 12th hour and 24th hour
Timepoint [2] 352964 0
At the postoperative 15th minute, 30th minute, 60th minute (secondary time-point), 120th min, 12th hour and 24th hour

Eligibility
Key inclusion criteria
Patients with ASA physical status I-III, between 18-70 years old, scheduled for a laparoscopic cholecystectomy
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The patients with coagulation disorder, known allergy to local anesthetics, infection at the injection site of the block, advanced hepatic or renal failure, chronic opioid consumption and body mass index?? equal to or higher than 35 kg m-2.

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). 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. Repeated measures analysis will be used for NRS scores and hemodynamic parameters. Normality checks will be carried out on the residuals which are approximately normally distributed. Values will be expressed as mean±standard deviation, median or as percentages.
Sample size of the study was calculated by G*Power (v3.1.9) program based on a pilot study with 10 patients in each group. At least 15% reduction in postoperative tramadol consumption at the 24th hour was accepted as clinically significant. Mean tramadol consumption was 140±22.04 mg in ESP group and 170±31.79 mg in OSTAP group. Assuming an alpha error 0.01 and ß error 0.1, 34 participants were needed per each group. Considering 10% drop-out, we decided to include at least 38 patients per group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/07/2018
Actual
9/07/2018
Date of last participant enrolment
Anticipated
16/07/2018
Actual
13/09/2018
Date of last data collection
Anticipated
17/07/2018
Actual
14/09/2018
Sample size
Target
76
Accrual to date
Final
68
Recruitment outside Australia
Country [1] 10570 0
Turkey
State/province [1] 10570 0
MUGLA

Funding & Sponsors
Funding source category [1] 299827 0
Hospital
Name [1] 299827 0
Mugla Sitki Koçman University Training and Reseach Hospital
Country [1] 299827 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] 299182 0
None
Name [1] 299182 0
Address [1] 299182 0
Country [1] 299182 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300706 0
Mugla Sitki Koçman University Training and Research Hospital Institutional Ethics Committee
Ethics committee address [1] 300706 0
Ethics committee country [1] 300706 0
Turkey
Date submitted for ethics approval [1] 300706 0
29/06/2018
Approval date [1] 300706 0
05/07/2018
Ethics approval number [1] 300706 0

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

Contacts
Principal investigator
Name 84546 0
Dr Basak ALTIPARMAK
Address 84546 0
Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 (postcode) Mentese/MUGLA
Country 84546 0
Turkey
Phone 84546 0
+905326726533
Fax 84546 0
Email 84546 0
[email protected]
Contact person for public queries
Name 84547 0
Basak ALTIPARMAK
Address 84547 0
Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 (postcode) Mentese/MUGLA
Country 84547 0
Turkey
Phone 84547 0
+905326726533
Fax 84547 0
Email 84547 0
[email protected]
Contact person for scientific queries
Name 84548 0
Basak ALTIPARMAK
Address 84548 0
Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 (postcode) Mentese/MUGLA
Country 84548 0
Turkey
Phone 84548 0
+905326726533
Fax 84548 0
Email 84548 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 on request
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?

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
EmbaseUltrasound-guided erector spinae plane block versus oblique subcostal transversus abdominis plane block for postoperative analgesia of adult patients undergoing laparoscopic cholecystectomy: Randomized, controlled trial.2019https://dx.doi.org/10.1016/j.jclinane.2019.03.012
N.B. These documents automatically identified may not have been verified by the study sponsor.