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Trial registered on ANZCTR


Registration number
ACTRN12618000524291
Ethics application status
Approved
Date submitted
6/02/2018
Date registered
10/04/2018
Date last updated
29/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does oblique subcostal transversus abdominis plane block effective as a multimodal analgesic technique after laparoscopic hysterectomy?
Scientific title
The Analgesic Efficacy of Oblique Subcostal Transversus Abdominis Plane Block After Laparoscopic Hysterectomy: A Randomized, Controlled, Observer Blinded Study
Secondary ID [1] 293966 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
laparoscopic hysterectomy
 306467 0
Condition category
Condition code
Surgery 305564 305564 0 0
Surgical techniques
Anaesthesiology 305565 305565 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study we are using an ultrasound procedure for transversus abdominis plane block for patients undergoing laparoscopic hysterectomy. After induction and intubation before the initiation of surgery OSTAP blocks will be performed under ultrasonography guidance using a linear 6 to 13 MHz ultrasound probe by the anesthesist. In group OSTAP patients will receive an ultrasound (US)-guided bilateral OSTAP block with 40 mL of 0.375% bupivacaine and tramadol patient-controlled analgesia (PCA) IV. The severity of pain according to visual analogue scale (VAS), total and cumulative tramadol consumption, incidence of nausea and vomiting will be assessed by the blind anesthesiologist who performed the block.
Intervention code [1] 300230 0
Treatment: Drugs
Comparator / control treatment
Patients in group no-TAP (control,received an US-guided bilateral OSTAP with 40 ml 0.9% saline. They received the same tramadol PCA. The severity of pain according to visual analogue scale (VAS), total and cumulative tramadol consumption, incidence of nausea and vomiting were assessed by the blind anesthesiologist who performed the block.
Control group
Placebo

Outcomes
Primary outcome [1] 304690 0
Primary outcome 1: 24-hour tramadol consumption will be assessed by checking patient controlled analgesia instrument
Timepoint [1] 304690 0
Postoperative 24th hour
Primary outcome [2] 304691 0
Primary outcome 2: Pain will be assessed by the patient using the visual analogue scale 24-hour visual analogue scale by patient visits at the postoperative 24th hour
Timepoint [2] 304691 0
postoperative 24th hour
Secondary outcome [1] 342807 0
Secondary outcome: pain will be assessed by the patient using the visual analogue scale at 1st, 4th and 12th hour.
Timepoint [1] 342807 0
Postoperative 1st, 4th and 12th hours
Secondary outcome [2] 345281 0
Secondary outcome: tramadol consumption will be assessed at 1st, 4th and 12th hour
Timepoint [2] 345281 0
Postoperative 1st, 4th and 12th hours

Eligibility
Key inclusion criteria
Patients aged between 18 and 65 years, with ASA physical status I to III, undergoing elective total laparoscopic hysterectomy will be included to the study.
Minimum age
18 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with a history of chronic opioid therapy in the 6 months before surgery, conversion to open surgical technique, aspartate aminotransferase and/or alanine aminotransferase >250 IU, creatinine level >1.4 mg/dL, pregnancy or lactation, known allergy to any drug used in the study, local infection at the block site and opioid abuse will be excluded from study.

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 administering the treatment/s
The people assessing the outcomes
Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
For statistical analysis, the Number Cruncher Statistical System (NCSS) 2007 & PASS (Power Analysis and Sample Size) 2008 Statistical Software (Utah, USA) program will be used. The descriptive data of the study will be specified with mean, standard deviation, median, frequency, rate, minimum and maximum. Mean tests will be compared using independent t -test if data distribution was normal or using nonparametric Mann-Whitney U test if data are not distributed normally. The p value <0.05 was considered as statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/04/2018
Actual
12/04/2018
Date of last participant enrolment
Anticipated
25/05/2018
Actual
25/05/2018
Date of last data collection
Anticipated
Actual
25/05/2018
Sample size
Target
60
Accrual to date
Final
66
Recruitment outside Australia
Country [1] 9559 0
Turkey
State/province [1] 9559 0
MUGLA

Funding & Sponsors
Funding source category [1] 298598 0
Hospital
Name [1] 298598 0
Mugla Sitki Kocman University Training and Research Hospital
Country [1] 298598 0
Turkey
Primary sponsor type
Individual
Name
MELIKE KORKMAZ TOKER
Address
Kötekli Mahallesi Mugla Sitki Koçman Üniversitesi Egitim ve Arastirma Hastanesi Anesteziyoloji ve Reanimasyon Anabilim Dali Mugla, 48001, Türkiye
Country
Turkey
Secondary sponsor category [1] 297753 0
None
Name [1] 297753 0
Address [1] 297753 0
Country [1] 297753 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299560 0
MUGLA SITKI KOCMAN UNIVERSITY CLINICAL TRIALS ETHICAL COMMITTEE
Ethics committee address [1] 299560 0
MUGLA SITKI KOCMAN UNIVERSITY CLINICAL TRIALS ETHICAL COMMITTEE. Mugla Sitki Kocman University Medical Faculty Dean Office 48001 MUGLA/TURKEY
Ethics committee country [1] 299560 0
Turkey
Date submitted for ethics approval [1] 299560 0
02/10/2017
Approval date [1] 299560 0
23/10/2017
Ethics approval number [1] 299560 0
MSKUEAH.23102017.4

Summary
Brief summary
Our aim is to assess whether ultrasound-guided subcostal oblique transversus abdominis plane (OSTAP) block would improve the postoperative pain scores and decrease the tramadol consumption after laparoscopic hysterectomy. Female patients between ages 18 and 65 years, with ASA I to III, undergoing elective total laparoscopic hysterectomy will be included in the study. Patients will be randomized into 2 groups. In group OSTAP, patients will receive bilateral OSTAP block and tramadol patient-controlled analgesia (PCA) IV for the first postoperative 24 hours. Patients in group no-TAP will receive an US-guided bilateral OSTAP with 40 ml 0.9% saline. They will receive the same tramadol PCA. The primary outcome measure of the study will be the 24-hour tramadol consumption. The secondary outcome measures of the study includes VAS scores and 1st, 4th and 12th hour tramadol consumptions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80838 0
Dr MELIKE KORKMAZ TOKER
Address 80838 0
Kötekli Mahallesi Mugla Sitki Koçman Üniversitesi Egitim ve Arastirma Hastanesi Anesteziyoloji ve Reanimasyon Anabilim Dali Mugla, 48001, Türkiye
Country 80838 0
Turkey
Phone 80838 0
+905054747098
Fax 80838 0
Email 80838 0
[email protected]
Contact person for public queries
Name 80839 0
MELIKE KORKMAZ TOKER
Address 80839 0
Kötekli Mahallesi Mugla Sitki Koçman Üniversitesi Egitim ve Arastirma Hastanesi Anesteziyoloji ve Reanimasyon Anabilim Dali Mugla, 48001, Türkiye
Country 80839 0
Turkey
Phone 80839 0
+905054747098
Fax 80839 0
Email 80839 0
[email protected]
Contact person for scientific queries
Name 80840 0
BASAK ALTIPARMAK
Address 80840 0
Kötekli Mahallesi Mugla Sitki Koçman Üniversitesi Egitim ve Arastirma Hastanesi Anesteziyoloji ve Reanimasyon Anabilim Dali Mugla, 48001, Türkiye
Country 80840 0
Turkey
Phone 80840 0
+905326726533
Fax 80840 0
Email 80840 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
SourceTitleYear of PublicationDOI
EmbaseThe analgesic efficacy of oblique subcostal transversus abdominis plane block after laparoscopic hysterectomy A randomized, controlled, observer-blinded study.2019https://dx.doi.org/10.1097/MD.0000000000013994
N.B. These documents automatically identified may not have been verified by the study sponsor.