Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616000719437
Ethics application status
Approved
Date submitted
7/05/2016
Date registered
31/05/2016
Date last updated
19/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of efficacy of local anesthetic injection to abdominal Wall in Patients Undergoing Cesarean Section with Spinal Anesthesia
Scientific title
Assessment of Postoperative Analgesia with Transversus Abdominus Plane Block in Patients Undergoing Cesarean Section with Spinal Anesthesia
Secondary ID [1] 289155 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anaesthesiology 298806 0
Condition category
Condition code
Alternative and Complementary Medicine 298853 298853 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ultrasound guided transversus abdominis plane blocks will be performed in pregnant women undergoing elective cesarean section with spinal anesthesia. Total of 60 women between 18 and 45 years of age with an ASA risk status of I-II and undergoing elective cesarean section under spinal anesthesia will include in this study. Patients will divide into two groups as follows: those who receive postoperative TAPB under ultrasound guidance (Group TAPB, 20 ml of 0.25% bupivacaine administered on each side, bilaterally, total dose: 40 ml) by consultant anesthetist, and those who do not receive postoperative TAPB (Group C). Also, all patients will provide patient-controlled analgesia with tramadol at first 24 hours(loading dose of 20 mg, with a lock-out time of 10 minutes and basal infusion rate of 20 mg/hour)
Intervention code [1] 294674 0
Treatment: Drugs
Comparator / control treatment
Pregnant women undergoing caesarean section under spinal anaesthesia, with no TAPB administered.
Control group
Active

Outcomes
Primary outcome [1] 298217 0
Visual analog scale to assess pain
Timepoint [1] 298217 0
5 minute intervals for the first 30 minutes after entry into the recovery room and at postoperative 1, 2, 4, 6, 12 and 24 hours
Primary outcome [2] 298218 0
tramadol consumption at recovery room by review of medical records
Timepoint [2] 298218 0
when the patient transports from recovery room to obstetric clinic.
Primary outcome [3] 298219 0
tramadol consumption at postoperative 24 hours by review medical records
Timepoint [3] 298219 0
at postoperative 24 hours
Secondary outcome [1] 323555 0
patients satisfaction via patient satisfaction score (5 for Strongly Agree, 4 for Agree, 3 for Undecided, 2 for Disagree and 1 for Strongly Disagree)
Timepoint [1] 323555 0
at postoperative 24 hours

Eligibility
Key inclusion criteria
elective cesarean section under spinal anesthesia
18 and 45 years of age
ASA risk status I-II
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Cardiovascular system acting drugs,
congestive heart failure,
diabetes mellitus,
haematological disorders,
chronic pain syndrome or recent use of analgesics,
obesity (BMI> 30 kg / m2)
sepsis, bacteremia, local skin infection, hypovolemia, coagulopathy, therapeutic anticoagulation, increased intracranial pressure, the refusal of the patient's treatment
repeated cesarean ones, placenta previa, placenta accreta, increate, placental abnormalities, such as perkeat to, eclampsia and preeclampsia, allergy to local anesthetics

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)
The sealed envelope procedure
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1:1, Simple randomisation using a randomisation table from a statistic book
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
according to G-Power 3.0.10, when effect size 0.5, alpha error 0.05, power 0.85 and allocation ratio 1 were adjusted, sample size found as 60.
Independent sample t test and ANOVA will perform to compare between groups for parametric data. VAS and satisfaction score will evaluate by Mann-Whitney U.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/06/2016
Actual
6/06/2016
Date of last participant enrolment
Anticipated
29/07/2016
Actual
29/09/2016
Date of last data collection
Anticipated
Actual
30/09/2016
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 7865 0
Turkey
State/province [1] 7865 0
Elazig

Funding & Sponsors
Funding source category [1] 293541 0
University
Name [1] 293541 0
Firat University
Country [1] 293541 0
Turkey
Primary sponsor type
University
Name
Firat University
Address
Firat University Hospital
Yunus Emre bulvari N0:1
23119, Elazig
Country
Turkey
Secondary sponsor category [1] 292355 0
None
Name [1] 292355 0
nil
Address [1] 292355 0
nil
Country [1] 292355 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294983 0
Firat University Ethic Comittee
Ethics committee address [1] 294983 0
Firat University Medical School
Yunus Emre Bulvari no:1
23119, Elazig
Ethics committee country [1] 294983 0
Turkey
Date submitted for ethics approval [1] 294983 0
08/07/2014
Approval date [1] 294983 0
02/09/2014
Ethics approval number [1] 294983 0

Summary
Brief summary
After obtainment of ethics committee approval and written informed consent from patients, a total of 60 women between 18 and 45 years of age with an ASA risk status of I-II and undergoing elective cesarean section under spinal anesthesia will include in this study. Patients will divide into two groups as follows: those who receive postoperative TAPB under ultrasound guidance (Group TAPB, 20 ml of 0.25% bupivacaine administere bilaterally), and those who will not receive postoperative TAPB (Group C). Also, all patients will provide patient-controlled analgesia with tramadol (loading dose of 20 mg, with a lock-out time of 10 minutes and basal infusion rate of 20 mg/hour). In order to assess the level of postoperative analgesia, VAS scores will record with 5-minute intervals after entry into the recovery room and at postoperative 1, 2, 4, 6, 12 and 24 hours. Also record will the tramadol doses at recovery and at postoperative 24 hours. Patient satisfaction will asses postoperatively at 24 hours.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65674 0
A/Prof Ayse Belin OZER
Address 65674 0
Firat University Medical School
Department of Anesthesiology and Reanimation
Yunus Emre Bulvari no:1
23119, Elazig
Country 65674 0
Turkey
Phone 65674 0
+90-424-2333555
Fax 65674 0
+90-424-2388096
Email 65674 0
[email protected]
Contact person for public queries
Name 65675 0
A/Prof Ayse Belin OZER
Address 65675 0
Firat University Medical School
Department of Anesthesiology and Reanimation
Yunus Emre Bulvari no:1
23119, Elazig
Country 65675 0
Turkey
Phone 65675 0
+90-424-2333555
Fax 65675 0
+90-424-2388096
Email 65675 0
[email protected]
Contact person for scientific queries
Name 65676 0
A/Prof Ayse Belin OZER
Address 65676 0
Firat University Medical School
Department of Anesthesiology and Reanimation
Yunus Emre Bulvari no:1
23119, Elazig
Country 65676 0
Turkey
Phone 65676 0
+90-424-2333555
Fax 65676 0
+90-424-2388096
Email 65676 0
[email protected]

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.