Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001106224
Ethics application status
Approved
Date submitted
20/06/2018
Date registered
3/07/2018
Date last updated
27/11/2018
Date data sharing statement initially provided
27/11/2018
Date results information initially provided
27/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Efficacy of Ultrasound-Guided Erector Spinae Plane Block for Postoperative Analgesia of Patients Undergoing Laparoscopic Cholecystectomy
Scientific title
The Efficacy of Ultrasound-Guided Erector Spinae Plane Block for Postoperative Analgesia of Adult Patients Undergoing Laparoscopic Cholecystectomy: A Prospective, Randomized, Controlled, Double Blinded Clinical Trial
Secondary ID [1] 295254 0
Nil known
Universal Trial Number (UTN)
U1111-1215-9561
Trial acronym
US-ESP for Cholecystectomy
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cholelithiasis 308425 0
postoperative pain 308426 0
Condition category
Condition code
Anaesthesiology 307413 307413 0 0
Pain management
Oral and Gastrointestinal 307532 307532 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
n 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 isotonic saline 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 US-ESP), the second anesthesiologist will locate the 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 the overlying 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 T7 transverse process. After the hydrodissection with 3 mL of isotonic saline solution confirmes correct needle tip position, the anesthesiologist will inject 20 mL of 0.25% bupivacaine deep to the erector spinae muscle. The same procedure will be repeated with 20 mL of 0.25% bupivacaine solution at the contralateral side. The block procedure will take approximately 10-15 minutes and then the anesthesiologists will start induction of anesthesia with intravenous propofol, fentanyl and rocuronium bromide.
Intervention code [1] 301589 0
Treatment: Surgery
Comparator / control treatment
In the second group (Group Control), the patients will receive the same bilateral US-ESP block with totally 40 ml isotonic saline (20 ml for each side).
Control group
Placebo

Outcomes
Primary outcome [1] 306388 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] 306388 0
At the postoperative 24th hour
Secondary outcome [1] 348315 0
To assess intraoperative fentanyl consumption by using data-linkage to surgical records
Timepoint [1] 348315 0
At the end of each surgery
Secondary outcome [2] 348316 0
To assess shoulder pain of the patients by directly asking the patients to rate their pain with a 3-points scale (0=no pain, 1=mild, 2=severe pain)
Timepoint [2] 348316 0
At the postoperative 15th minute, 30th minute, 60th minute (secondary time-point), 12th hour, 24th hour
Secondary outcome [3] 350660 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 time-point), 12th hour and 24th hour
Timepoint [3] 350660 0
at the postoperative 15th minute, 30th minute, 60th minute (secondary time-point), 12th hour and 24th hour

Eligibility
Key inclusion criteria
The patients between 18-70 years of age with ASA status I-II, and scheduled for an elective laparoscopic cholecystectomy surgery,
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, advanced hepatic or renal failure, chronic opioid consumption and morbid obesity (body mass index over 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 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, median, 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 based on a preliminary study with 10 patients in each group. At least 20% difference in postoperative tramadol consumption at the 24th hour was accepted as clinically significant. The mean tramadol consumption in ESP group was 95 mg and it was 128 mg in Control group. Assuming an alpha error as 0.01 and beta error as 0.1, at least 15 patients were needed to provide a power 90%. Considering possible drop-outs, we decided to include at least 20 patients per group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/07/2018
Actual
6/07/2018
Date of last participant enrolment
Anticipated
20/07/2018
Actual
27/07/2018
Date of last data collection
Anticipated
21/07/2018
Actual
28/07/2018
Sample size
Target
40
Accrual to date
Final
41
Recruitment outside Australia
Country [1] 10577 0
Turkey
State/province [1] 10577 0
MUGLA

Funding & Sponsors
Funding source category [1] 299846 0
Hospital
Name [1] 299846 0
Mugla Sitki Koçman University Training and Research Hospital
Country [1] 299846 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] 299201 0
None
Name [1] 299201 0
Address [1] 299201 0
Country [1] 299201 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300723 0
Mugla Sitki Koçman University Training and Research Hospital Institutional Ethics Committee
Ethics committee address [1] 300723 0
Mugla Sitki Koçman University Training and Research Hospital, Marmaris Yolu üzeri, M Kapi Karsisi, 48000 Mugla
Ethics committee country [1] 300723 0
Turkey
Date submitted for ethics approval [1] 300723 0
28/06/2018
Approval date [1] 300723 0
02/07/2018
Ethics approval number [1] 300723 0
decision number XXI

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

Contacts
Principal investigator
Name 84602 0
Dr Basak ALTIPARMAK
Address 84602 0
Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 (postcode) Mentese/MUGLA
Country 84602 0
Turkey
Phone 84602 0
+905326726533
Fax 84602 0
Email 84602 0
basakugurlu@me.com
Contact person for public queries
Name 84603 0
Basak ALTIPARMAK
Address 84603 0
Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 (postcode) Mentese/MUGLA
Country 84603 0
Turkey
Phone 84603 0
+905326726533
Fax 84603 0
Email 84603 0
basakugurlu@me.com
Contact person for scientific queries
Name 84604 0
Basak ALTIPARMAK
Address 84604 0
Mugla Sitki Koçman Üniversitesi Tip Fakültesi. Marmaris yolu üzeri M kapi karsisi. 48000 (postcode) Mentese/MUGLA
Country 84604 0
Turkey
Phone 84604 0
+905326726533
Fax 84604 0
Email 84604 0
basakugurlu@me.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 on request; ending 1 year after 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
No additional documents have been identified.