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Trial registered on ANZCTR


Registration number
ACTRN12617000891325
Ethics application status
Approved
Date submitted
26/05/2017
Date registered
16/06/2017
Date last updated
31/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of Subcostal Transversus Abdominis Plane Block and Quadratus Lumborum Block in Laparoscopic Cholecystectomy with Ultrasonography as a Preventive Analgesia Method
Scientific title
Comparison of Subcostal Transversus Abdominis Plane Block and Quadratus Lumborum Block in Laparoscopic Cholecystectomy with Ultrasonography as a Preventive Analgesia Method
Secondary ID [1] 292049 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gallstones/Chololithiasis 303450 0
Condition category
Condition code
Surgery 302860 302860 0 0
Other surgery
Anaesthesiology 302861 302861 0 0
Pain management
Oral and Gastrointestinal 302862 302862 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
The patients ' demographic data was recorded. The patients will be divided into two groups. Patients distributed to groups with closed envelope technique
Group I (n=50): Subcostal transversus abdominis plane block group
Subcostal transversus abdominis plane blocks were performed under ultrasound guidance after induction of anesthesia, before beginning of surgery by the same anesthesiologist who performed block at least 20 times. 1,5 mg/kg %0.25 Bupivacaine (Marcaine (R) AstraZeneca: Istanbul, Turkey)injected in the transversus abdominis fascial plane under direct visualization.
Group II (n=50):Quadratus lumborum block group
Quadratus lumborum blocks were performed under ultrasound guidance after induction of anesthesia, before beginning of surgery by the same anesthesiologist who performed block at least 20 times. 1,5mg/kg %0,25 Bupivacaine (Marcaine (R) AstraZeneca: Istanbul, Turkey)injected in the quadratus lumborum fascial plane under direct visualization.
The patients received patient-controlled intravenous analgesia (PCA) with 54 ml normal saline + 300 mg tramadol (Tramosel (R), Haver, Istanbul, Turkey) for postoperative pain management (bolus dose: 5 ml, lockout period: 30 minutes,without loading dose). All patients received intravenous analgesia via the same type of PCA (Patient Controlled Analgesia) device for 24 hours period.
When the pain level is higher than three (0=no pain; 10=severe pain), the patient can use the patient controlled analgesia pump. If the pain still exist, additional analgesic will be applied by the same anesthesiologist who assessed outcomes and the number of additional analgesic was recorded
Intervention code [1] 298178 0
Treatment: Drugs
Comparator / control treatment
Group II (n=50):Quadratus lumborum block group
Quadratus lumborum blocks were performed under ultrasound guidance after induction of anesthesia, before beginning of surgery by the same anesthesiologist who performed block at least 20 times. 1,5mg/kg %0,25 Bupivacaine (Marcaine (R) AstraZeneca: Istanbul, Turkey)injected in the quadratus lumborum fascial plane under direct visualization.
Control group
Active

Outcomes
Primary outcome [1] 302253 0
rate of analgesic consumption in the 24 hours after surgery between two blocks groups.
Datas of analgesic agent consumption are assessed by review of medical records. Analgesic consumption will be calculated by the total amount of analgesic agents spent on Patient-controlled analgesia (PCA)
Timepoint [1] 302253 0
24 hours post surgery
Primary outcome [2] 302254 0
time of first analgesic requirement
this information is taken from patients themselves
Timepoint [2] 302254 0
at any time in the 24 hours
Primary outcome [3] 302255 0
Pain, assessed by visual analogue scale at rest and during coughing
Timepoint [3] 302255 0
at 0-1-6-12-24. hours
Secondary outcome [1] 335303 0
Adverse effects (itching, allergies, nausea, vomiting, urinary retention, constipation, respiratory depression, bradycardia, hypotension, dizziness ,hallucination i.e.)
Timepoint [1] 335303 0
during intraoperative process and 24 hours post surgery

Adverse events were recorded. If adverse events were recognized, They were evaluated according to Common Terminology Criteria for Adverse Events (CTC-AE) ver. 4.0.
This adverse events listed are assessed as recorded by treating clinician in the medical records

Eligibility
Key inclusion criteria
Elective surgery
laparosopic cholecystectomy
ASA (American Society of Anesthesiologist) Score) I-II
who can talk turkish language.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
blood coagulation pathologies
allergies against local anaesthetics
inability to understand the study protocol
body mass index >35
infection on the block area

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/07/2017
Actual
10/07/2017
Date of last participant enrolment
Anticipated
Actual
2/10/2017
Date of last data collection
Anticipated
Actual
3/10/2017
Sample size
Target
120
Accrual to date
Final
107
Recruitment outside Australia
Country [1] 8921 0
Turkey
State/province [1] 8921 0
bursa

Funding & Sponsors
Funding source category [1] 296583 0
Self funded/Unfunded
Name [1] 296583 0
cagdas baytar
Country [1] 296583 0
Turkey
Funding source category [2] 296584 0
Self funded/Unfunded
Name [2] 296584 0
canan yilmaz
Country [2] 296584 0
Turkey
Funding source category [3] 296585 0
Self funded/Unfunded
Name [3] 296585 0
derya karasu
Country [3] 296585 0
Turkey
Primary sponsor type
Individual
Name
canan yilmaz
Address
Bursa Yuksek Ihtisas Training Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood /Emniyet Street/16310 Yildirim/Bursa
Country
Turkey
Secondary sponsor category [1] 295537 0
Individual
Name [1] 295537 0
derya karasu
Address [1] 295537 0
Bursa Yuksek Ihtisas Training Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood /Emniyet Street/16310 Yildirim/Bursa
Country [1] 295537 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297806 0
Bursa Uludag University Medicine Faculty Ethics Committee
Ethics committee address [1] 297806 0
Ozluce neighborhood, 16059 Nilufer/Bursa/Turkey
Ethics committee country [1] 297806 0
Turkey
Date submitted for ethics approval [1] 297806 0
10/03/2017
Approval date [1] 297806 0
28/03/2017
Ethics approval number [1] 297806 0
2017-4/19

Summary
Brief summary
Purpose:Ultrasound-guided quadratus lumbar block and transversus abdominis are effective methods for analgesia in operations involving the abdominal region of the abdominal plane and are increasingly used. Many studies have shown that they provide less complications and longer effective analgesia than conventional analgesia regimens. In our clinic, it was planned to compare these methods, which are routinely used for preventive purposes, in terms of efficacy on pain. We aimed to contribute to the literature by comparing the obtained data with the existing literature information.

Methods: In this study the patients who can speak Turkish and who have chololithiasis and planned elective laporoscophic cholecistectomy surgery, aged between 18-75 years with ASA (American Society of Anesthesiologist) Score I-II were included. We excluded patients with blood coagulation pathologies, allergies against local anaesthetics , inability to understand the study protocol, body mass index greater than thirty five or infection on the block area.

Demographic data (age, height, weight, gender, ASA) of the patients will be recorded. Patients will be divided into 2 groups of 100 patients according to closed envelope method.
Group 1 (n = 50): General anesthesia will be applied with the drugs applied in the patient's routine. Subcostal Transversus Abdominis Plane block will be performed in the presence of ultrasound after intubation. 1,5 mg / kg 0.25% Bupivacain will be applied on each side in our routine.
Group 2 (n = 50): General anesthesia will be applied with the drugs applied in the patient's routine. Post-intubation Quadratus Lumborum Block will be performed in the presence of ultrasound. Each side will be treated with 1,5 mg / kg 0.25% Bupivacain applied on the route.

After the operation, to obtain minimum level of pain, patients controlled analgesia pump was applied via intravenous way to the patients. Then the level of pain was observed through the visual analog scale at 0-1-6-12-24h postoperatively both while coughing and at rest.


When the pain level is higher than three (0=no pain; 10=severe pain), the patient can use the patient controlled analgesia pump. If the pain still exist, additional analgesic was applied and the number of additional analgesic will be recorded accordingly
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75150 0
Dr cagdas baytar
Address 75150 0
Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/Bursa
Country 75150 0
Turkey
Phone 75150 0
+90 554 225 59 60
Fax 75150 0
Email 75150 0
cagdasbaytar31@gmail.com
Contact person for public queries
Name 75151 0
canan yilmaz
Address 75151 0
Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/Bursa
Country 75151 0
Turkey
Phone 75151 0
+90 505 904 59 89
Fax 75151 0
Email 75151 0
canan.yilmaz12@saglik.gov.tr
Contact person for scientific queries
Name 75152 0
canan yilmaz
Address 75152 0
Bursa Yuksek Ihtisas Training and Education Hospital Clinic of Anesthesiology and Reanimation Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/Bursa
Country 75152 0
Turkey
Phone 75152 0
+90 505 904 59 89
Fax 75152 0
Email 75152 0
canan.yilmaz12@saglik.gov.tr

No information has been provided regarding IPD availability


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
EmbaseComparison of ultrasound-guided subcostal transversus abdominis plane block and quadratus lumborum block in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical study.2019https://dx.doi.org/10.1155/2019/2815301
N.B. These documents automatically identified may not have been verified by the study sponsor.