Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001763134p
Ethics application status
Submitted, not yet approved
Date submitted
16/11/2019
Date registered
11/12/2019
Date last updated
11/12/2019
Date data sharing statement initially provided
11/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Analgesic effect of Erector spinae plane block (ESPB) for the operation of lumbar disc herniation
Scientific title
Assessment of ultrasound-guided erector spinae plane block for intraoperative and postoperative analgesia in lumbar disc hernia surgery
Secondary ID [1] 295666 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
surgical wound pain relief
 315230 0
lumbar disc hernia surgery 315231 0
Condition category
Condition code
Anaesthesiology 313537 313537 0 0
Pain management
Musculoskeletal 313829 313829 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Erector spinae plane (ESP) block Technique: It is a single shot technique performed by an anesthetist ( one of the investigators) at the beginning of the surgical procedure in the operation room. An in-plane approach in the prone position will be attempted under the ultrasound guidance. Using a 6- to 15-MHz high-frequency linear probe, Erector spinae (ES) muscles will be visualized at the L3 transverse process 22g needle will be used to locate ES, after saline test dose 0.25% bupivacaine (20 mL per side) will be administered. This ESP block is monitored in the recovery room and assessed how effective in providing postoperative pain relief in lumbar disc hernia surgery.
Intervention code [1] 316092 0
Prevention
Comparator / control treatment
The erector spinae plane (ESP) block will not be applied to the control group. Remifentanil (0.25 – 0.5 mcg kg-1 min) will be used for intraoperative analgesia. Tramadol (1 mg kg-1) and paracetamol (1g) will be used for postoperative analgesia.
Control group
Active

Outcomes
Primary outcome [1] 321989 0
The primary aim of this study is to assess the pain scores at either rest or motion are assessed by 10-point VAS.
Timepoint [1] 321989 0
Post anesthesia care unit and at 24 hours are assessed by 10-point VAS
Secondary outcome [1] 376932 0
The secondary aim of this study is to assess the effect of ESP block on postoperative opioid consumtion by checking patient controlled analgesia
Timepoint [1] 376932 0
Postanesthesia care unit and at 24 hours is by patient-controlled analgesia device

Eligibility
Key inclusion criteria
ASA 1-2 for lumbar disc hernia surgery under general anesthesia between the age of 18-75 yrs.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The patient does not want to participate in the study
Under 18 and over 75
People with coagulopathy
Antiaggregant and anticoagulant drug users
Pregnancy
Breast-feeding
Prior to having had spine surgery
Diagnosed with malignancy
Metastasis in the spine

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The data will be analysed using the following methods: differences between the
continuous variables by the “t”-test; categorical variables by Fisher's exact test. For data without normal distribution, Mann Whitney U test was performed. Ratios were compared using Chi Square. Categorical variables were compared using Fisher exact test. A p-value of<0.05 was considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/01/2020
Actual
Date of last participant enrolment
Anticipated
2/06/2020
Actual
Date of last data collection
Anticipated
30/06/2020
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 22120 0
Turkey
State/province [1] 22120 0
Erzurum

Funding & Sponsors
Funding source category [1] 300246 0
Hospital
Name [1] 300246 0
University Of Health Sciences Erzurum Regional Education and Research Hospital
Country [1] 300246 0
Turkey
Primary sponsor type
Hospital
Name
University Of Health Sciences Erzurum Regional Education and Research Hospital
Address
Atatürk neighborhood, Çat yolu Street, Palandöken/Yakutiye/Erzurum, 25070
Country
Turkey
Secondary sponsor category [1] 304541 0
None
Name [1] 304541 0
Address [1] 304541 0
Country [1] 304541 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301069 0
University of Health Sciences Erzurum Regional Education and Research Hospital Ethics Committee
Ethics committee address [1] 301069 0
Atatürk neighborhood, Çat yolu Street, Palandöken/Yakutiye/Erzurum, 25070
Ethics committee country [1] 301069 0
Turkey
Date submitted for ethics approval [1] 301069 0
12/11/2019
Approval date [1] 301069 0
Ethics approval number [1] 301069 0

Summary
Brief summary
The study will be conducted at the University of Health Sciences Erzurum Regional Education and Research Hospital with patients who are scheduled for elective lumbar disc hernia surgery. This study aimed to evaluate the effect of erector spinae plane (ESP) block on postoperative pain levels. Efficiency is assessed by pain score, analgesic use, and other outcomes.
We hypothesize; that ultrasound-guided ESP block in lumbar disc hernia operation will reduce postoperative pain level.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85774 0
Mr yasin taskaldiran
Address 85774 0
Health Sciences University Erzurum Regional Training and Research Hospital, Çat yolu Street/Yakutiye, Erzurum, 25070
Country 85774 0
Turkey
Phone 85774 0
+0905342525487
Fax 85774 0
Email 85774 0
[email protected]
Contact person for public queries
Name 85775 0
Mr yasin taskaldiran
Address 85775 0
Health Sciences University Erzurum Regional Training and Research Hospital, Çat yolu Street/Yakutiye, Erzurum, 25070
Country 85775 0
Turkey
Phone 85775 0
+0905342525487
Fax 85775 0
Email 85775 0
[email protected]
Contact person for scientific queries
Name 85776 0
Mr yasin taskaldiran
Address 85776 0
Health Sciences University Erzurum Regional Training and Research Hospital, Çat yolu Street/Yakutiye, Erzurum, 25070
Country 85776 0
Turkey
Phone 85776 0
+0905342525487
Fax 85776 0
Email 85776 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.