Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000466943
Ethics application status
Approved
Date submitted
29/01/2020
Date registered
9/04/2020
Date last updated
22/12/2021
Date data sharing statement initially provided
9/04/2020
Date results provided
22/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation of the effect of erector spinae plane block, a new pain-relieving method for the relief of post-operative pain in patients whose part of the liver will be removed.
Scientific title
Investigation of the Effect of Ultrasonography Guided Bilateral Erector Spina Plane Block on Postoperative Opioid Consumption and Pain Scores in Patients with Hepatectomy Operation: A Prospective, Randomized, Controlled Study
Secondary ID [1] 300369 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatectomy 316005 0
Postoperative Analgesia 316524 0
Condition category
Condition code
Anaesthesiology 314277 314277 0 0
Pain management
Oral and Gastrointestinal 314771 314771 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 315140 315140 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ESP Block Application:All blocks will be performed by an anesthesiologist experienced in the block approximately 30 minutes before anesthesia induction. The block will be made at the level of the T8 vertebra. The T7 vertebra that corresponds to the level of the lower ends of the scapula will be identified and the T8 vertebra below one level will be detected by palpation. Patients will be laid in prone position and skin preparation will be done with 10% povidone iodine. Skin-subcutaneous anesthesia will be provided with 3 ml 2% lidocaine at the target injection site. T8 spinous process in the midline and horizontal plane will be displayed first by using a linear probe coated with a sterile drape at 8 mHz frequency accompanied by ultrasonography. The probe is then turned to the longitudinal plane, approximately 3 cm from the midline, the transverse process on the left lateral and the erector spina muscle will be displayed on it. The 22-gauge, 80-mm block needle will be advanced cranio-caudal as in-plane and the transverse process will be touched. Then, after the needle is minimally retracted, 20 ml 0.375% bupivacaine hydrochloride + 4 mg dexamethasone will be injected, and simultaneous local anesthetic emission will be monitored by ultrasonography. By applying the same procedure to the right side, bilateral ESP block will be performed. Loss of sensation of warm-cold sensation below and above the bilateral T8 dermatome level 20 minutes after the block is made will be considered as block success. Participants in this group will also receive PCA postoperatively.
Intervention code [1] 316662 0
Treatment: Drugs
Comparator / control treatment
Patients who will not block and use only patient control analgesia (PCA) device for postoperative analgesia will form the Control Group (Group C).Without PCA basal infusion dose, 1 mg / ml dose of morphine will be programmed as 1 ml per bolus and lock-out time of 6 minutes.
Control group
Active

Outcomes
Primary outcome [1] 322666 0
The primary outcome measure of the study will be total morphine consumption in the first 24 hours postoperatively. This outcome will be assessed by audit of patient controlled analgesia machine
Timepoint [1] 322666 0
Post-operative first 24 hours
Secondary outcome [1] 379236 0
Resting and dynamic numering rating scale (NRS) scores will be assessed by verbal assessment of the patient at post-operative 5 different time points (postoperative 10th minute, 1st hour, 6th hour, 12th hour and 24th hour).
Timepoint [1] 379236 0
Post-operative 10th minute, 1st hour, 6th hour, 12th hour and 24th hour.
Secondary outcome [2] 380864 0
Intraoperative remifentanil consumption will be assessed by audit of perfusion machine.
Timepoint [2] 380864 0
During operation time
Secondary outcome [3] 380865 0
Total recovery analgesic requirement in the first 24 hours postoperatively will be assessed by medical nurse records.
Timepoint [3] 380865 0
Post-operative first 24 hours

Eligibility
Key inclusion criteria
Patients with ASA physical status I-III, who will undergo elective hepatectomy surgery, bilateral subcostal incision as surgical incision, and self-retaining retractor will be used in surgery will be included.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Obese (body mass index> 30 kg / m2), local skin infection in the area where the needle will be inserted, known allergy to any of the drugs to be used in the study, coagulopathy, chronic opioid consumption, disability to use PCA device, patients with advanced hepatic insufficiency, advanced renal insufficiency and refusal to participate in the study will be excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be randomized by lot using the closed opaque technique and their groups will be determined. This process will be carried out by a researcher who is not involved in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Closed Opaque Technique
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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 data obtained as a result of the research will be analyzed through appropriate statistical package programs. Parametric or nonparametric tests will be used according to the measurement levels and normality analyzes of the variables. While determining whether there is a difference between the groups in terms of variables; Independent Samples T test in two group comparisons or Mann-Whitney U test, One Way Anova or Kruskall-Wallis H test in three or more group comparisons. Paired Samples T test or Wilcoxon Signed Rank test will be used for intra-group time-based comparisons.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2020
Actual
1/05/2020
Date of last participant enrolment
Anticipated
Actual
30/11/2020
Date of last data collection
Anticipated
Actual
1/12/2020
Sample size
Target
50
Accrual to date
Final
50
Recruitment outside Australia
Country [1] 22273 0
Turkey
State/province [1] 22273 0
Konya

Funding & Sponsors
Funding source category [1] 304794 0
University
Name [1] 304794 0
Necmettin Erbakan University
Country [1] 304794 0
Turkey
Primary sponsor type
University
Name
Necmettin Erbakan University Scientific Research Project Coordinator
Address
Meram Faculty of Medicine Hospital
Hocacihan Neighborhood
Abdülhamid Han Street
Number: 3
Post Code: 42080
Selçuklu Konya
Country
Turkey
Secondary sponsor category [1] 305114 0
Government body
Name [1] 305114 0
TÜBITAK Turkey Scientific and Technical Research Council
Address [1] 305114 0
Tunus Street No:80 06100 Postcode:6680 Kavaklidere Ankara
Country [1] 305114 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305208 0
Turkey Pharmaceuticals and Medical Devices Agency
Ethics committee address [1] 305208 0
Ethics committee country [1] 305208 0
Turkey
Date submitted for ethics approval [1] 305208 0
22/11/2019
Approval date [1] 305208 0
14/12/2019
Ethics approval number [1] 305208 0
66175679-514.04.01-E.214738

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

Contacts
Principal investigator
Name 99614 0
Dr Gülçin Hacibeyoglu
Address 99614 0
Necmettin Erbakan University Meram Medical Faculty
Hocacihan Neighborhood
Abdülhamid Han Street
Number:3
Post Code:42080
Selçuklu Konya
Country 99614 0
Turkey
Phone 99614 0
+905054455498
Fax 99614 0
Email 99614 0
[email protected]
Contact person for public queries
Name 99615 0
Gülçin Hacibeyoglu
Address 99615 0
Necmettin Erbakan University Meram Medical Faculty
Hocacihan Neighborhood
Abdülhamid Han Street
Number:3
Post Code:42080
Selçuklu Konya
Country 99615 0
Turkey
Phone 99615 0
+905054455498
Fax 99615 0
Email 99615 0
[email protected]
Contact person for scientific queries
Name 99616 0
Gülçin Hacibeyoglu
Address 99616 0
Necmettin Erbakan University Meram Medical Faculty
Hocacihan Neighborhood
Abdülhamid Han Street
Number:3
Post Code:42080
Selçuklu Konya
Country 99616 0
Turkey
Phone 99616 0
+905054455498
Fax 99616 0
Email 99616 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?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Following publication no end date determined
Available to whom?
Only researchers
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 by emailing the Principal Investigator ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6650Study protocol  [email protected] 379139-(Uploaded-29-01-2020-20-02-14)-Study-related document.docx



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.