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Trial registered on ANZCTR


Registration number
ACTRN12617000842369
Ethics application status
Approved
Date submitted
1/05/2017
Date registered
7/06/2017
Date last updated
7/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ultrasound guided transversus abdominis plane (TAP) block and Quadratus lumborum (QL) block for analgesia after caesarean surgery which is performed under general anesthesia.
Scientific title
Comparison of Ultrasound guided transversus abdominis plane (TAP) block and Quadratus lumborum (QL )block for postoperative pain relief in caesarean surgery.
Secondary ID [1] 291603 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative pain 303017 0
Caesarean surgery 303051 0
Condition category
Condition code
Anaesthesiology 302476 302476 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of Ultrasound guided transversus abdominis plane (TAP) block and quadratus lumborum (QL) block for pain relief after caesarean surgery which is perforemed under general anesthesia.

Equipment
Ultrasound – linear array probe
22G 100mm Stimuplex needle
Study drug – 0.3ml/kg 0.25% bupivacaine
Betadine antiseptic for skin preparation
Standard monitoring and resuscitation equipment
Patient controled analgesia device

All patients will receive standard premedication, monitoring and anesthesia care.
Adequate preparations will be made for the possibility of difficult airway. Propofol 2-3 mg/kg iv and rocuronium 1 mg/kg iv will be used for induction of anesthesia.
All patients will recieve fentanyl 1.5 mcg/kg iv and tenoxicam 20 mg iv
After the completion of the surgical procedure one of the analgesia methods used for postoperative analgesia will be performed.

TAP block technique
The patient is in the supine position.
Ultrasound will be positioned in the mid axillary line in the axial plane half way between the iliac crest and the costal margin.
Structures to be identified: subcutaneous fat, external oblique muscle, internal oblique muscle, transversus abdominis muscle, peritoneum and intraperitoneal structures.
The needle is inserted 'in plane' and directed to lie between the internal oblique and transversus abdominis under ultrasound guidance.
To confirm location, 2ml of local anaesthetic can be injected.
Patient will receive 0.3ml/kg 0.25% bupivacaine on each side

QL block technique
The patient is in the supine position.
Ultrasound positioned in the mid axillary line in the axial plane half way between the iliac crest and the costal margin.
Probe will be moved posteriorly until the QL muscle is confirmed . The needle tip will be placed at the anterolateral border of the QL at its junction of QL with transversalis fascia, and the local anesthetic will be injected.
Patient will receive 0.3ml/kg 0.25% bupivacaine on each side

Intervention code [1] 297897 0
Treatment: Drugs
Comparator / control treatment
Ultrasound guided transversus abdominis plane block with quadratus lumborum block at the end of the caesarean section.
Control group
Active

Outcomes
Primary outcome [1] 301920 0
Total cumulative opioid consumption in Patient Controlled Analgesia Device
Timepoint [1] 301920 0
24 hours postoperative
Secondary outcome [1] 334277 0
Severity of postoperative pain via visual analogue pain scale (VAS)
Timepoint [1] 334277 0
First in the recovery room
Then 2. 4. 8. 12. and 24. hours after surgery

Eligibility
Key inclusion criteria
Elective caesarean sections ASA 1 to 2 performed under general anesthesia
Written informed consent.
Minimum age
18 Years
Maximum age
49 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patient refusal
Local infection at the site of injection
Allergy to study medications
Coagulopathy
Inability to speak Turkish language

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)
sealed opaque envelopes
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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
3/04/2017
Date of last participant enrolment
Anticipated
31/07/2017
Actual
Date of last data collection
Anticipated
15/08/2017
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 8856 0
Turkey
State/province [1] 8856 0
Bursa

Funding & Sponsors
Funding source category [1] 296090 0
Hospital
Name [1] 296090 0
Bursa Yuksek Ihtisas Training and research Hospital
Country [1] 296090 0
Turkey
Primary sponsor type
Hospital
Name
Bursa Yuksek Ihtisas Training and research Hospital
Address
Mimar Sinan Mah. Emniyet Cad. Polis Okulu Karsisi Postcode: 16310Yildirmi / BURSA
Country
Turkey
Secondary sponsor category [1] 294986 0
None
Name [1] 294986 0
Address [1] 294986 0
Country [1] 294986 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297346 0
Uludag University Faculty of Medicine Clinical Research Ethics Committee
Ethics committee address [1] 297346 0
Ethics committee country [1] 297346 0
Turkey
Date submitted for ethics approval [1] 297346 0
10/03/2017
Approval date [1] 297346 0
28/03/2017
Ethics approval number [1] 297346 0
2017-4/20

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

Contacts
Principal investigator
Name 73770 0
Dr Canan Yilmaz
Address 73770 0
Bursa Yuksek Ihtisas Training and Research Hospital
Anesthesiology and Reanimation Department

Mimar Sinan Mah. Emniyet Cad. Postcode: 16310 Yildirimi / BURSA
Country 73770 0
Turkey
Phone 73770 0
+90224 295 50 00 ext5339
Fax 73770 0
Email 73770 0
canan.yilmaz12@saglik.gov.tr
Contact person for public queries
Name 73771 0
Umit Caglayan
Address 73771 0
Bursa Yuksek Ihtisas Training and Research Hospital
Anesthesiology and Reanimation Department

Mimar Sinan Mah. Emniyet Cad. Postcode: 16310 Yildirim / BURSA
Country 73771 0
Turkey
Phone 73771 0
+90224 295 50 00 ext5347
Fax 73771 0
Email 73771 0
umit.caglayan@saglik.gov.tr
Contact person for scientific queries
Name 73772 0
Umit Caglayan
Address 73772 0
Bursa Yuksek Ihtisas Training and Research Hospital
Anesthesiology and Reanimation Department

Mimar Sinan Mah. Emniyet Cad. Postcode: 16310 Yildirim / BURSA
Country 73772 0
Turkey
Phone 73772 0
+90224 295 50 00 ext5347
Fax 73772 0
Email 73772 0
umit.caglayan@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
No additional documents have been identified.