Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000784617
Ethics application status
Approved
Date submitted
21/06/2023
Date registered
18/07/2023
Date last updated
18/07/2023
Date data sharing statement initially provided
18/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of the Pain Relief Efficacy of Epidural Analgesia and Erector Spinae Plane Block Applied Before open Thoracic Surgery
Scientific title
Effectiveness Comparison Of Preemptive Single-Dose Thoracic Epidural Analgesia And Erector Spinae Plane Block For Thoracotomy Analgesia In Thoracic Surgery
Secondary ID [1] 309945 0
none
Universal Trial Number (UTN)
U1111-1294-0484
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung tissue diseases 330425 0
Condition category
Condition code
Respiratory 327264 327264 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group TEA (Thoracic Epidural Analgesia): Thoracic Epidural Application: The epidural area will be accessed from the 7th (T7)-8th (T8) level of the thoracic vertebral midline with an 18 gauge (G) epidural needle using the hanging drip technique. After 2 ml of 2% lidocaine is administered and no spinal effect is observed, a mixture of morphine and local anaesthetic 3-4 mg morphine hydrochloride + 5 ml 0.5% bupivacaine + 2 ml 0.9% saline will be administered through the epidural needle at once and the epidural needle will be withdrawn and sterile dressing will be applied.

- The mode of presentation will be face-to-face and individually.
- The intervention will be performed by an anaesthetist with at least 5 years of experience.
- The stages of the intervention will be verbally explained in detail to participants prior to the intervention.
- The patient will be taken to the operating table and electrocardiographic, oxygen saturation with psilse oximetry and non-invasive blood pressure monitoring with automatic manometer will be performed.
-

The intervention will be administered only once, 3-4 mg of morphine hydrochloride + 5 ml of 0.5 % bupivacaine + 2 ml of 0.9 % saline into the epidural space.
- Immediately before induction of anaesthesia, the patient will be seated and after appropriate sterilisation conditions are provided, the thoracic epidural space will be reached and the analgesic mixture will be given once and the space will be exited.
- Immediately after sterile dressing of the intervention site, the patient will be placed supine and standard general anaesthesia will be applied.
- The intervention will be performed in the thoracic surgery room of our hospital operating theatre.
Intervention code [1] 326364 0
Treatment: Surgery
Comparator / control treatment
Grup ESP ( Erector spinae plane block): Before induction of anaesthesia, the patient will be placed on the operating table and placed in a forward tilted position. Asepsis and antisepsis conditions will be fulfilled.
The linear USG probe (5-12 MHz, Mindray DP-50, China) will first be placed in the sagittal plane to visualise the vertebral spinous process. Then the linear probe was moved approximately 2-3 cm lateral to the spinous process T5 - T6 level on the side to be operated on, and the probe will be rotated 90 degrees to the longitudinal plane to visualise the transverse process. The trapezius, rhomboid major and erector spinae muscles will be identified to find the correct probe position. A 22G 50 mm or 22G 80 mm SonoPlex needle will be inserted through the skin in a cranio-caudal direction. With the needle resting on the transverse process, the plane between the erector spinae muscle and the transverse process will be verified by hydrodissection with 5 ml saline solution. Then, 20 ml of 0.25% bupivacaine will be injected. The ESP block will be considered successful if the local anaesthetic spreads linearly up to the T8 - T9 level. The patient will then be placed in the supine position and general anaesthesia will be administered.

- The mode of presentation will be face-to-face and individually.
- The intervention will be performed by an anaesthetist with at least 5 years of experience.
- The stages of the intervention will be verbally explained in detail to participants prior to the intervention.
- The patient will be taken to the operating table and electrocardiographic, oxygen saturation with psilse oximetry and non-invasive blood pressure monitoring with automatic manometer will be performed.
- The intervention will be performed only once on the side of the surgical incision and 20 ml of 0.25% bupivacaine will be injected once into the relevant area.
- Immediately before induction of anaesthesia, the patient will be seated and after appropriate sterilisation conditions are provided, the fascia of the erector spina muscle will be reached under ultrasound guidance and the analgesic solution will be given to this area only once and the cavity will be exited.
- Immediately after sterile dressing of the intervention site, the patient will be placed supine and standard general anaesthesia will be applied.
- The intervention will be performed in the thoracic surgery room of our hospital operating theatre.
Control group
Active

Outcomes
Primary outcome [1] 335140 0
100 mm Visual Analogue Scale (VAS) will be used to assess the pain of the thoracotomised chest area
Timepoint [1] 335140 0
-In the postoperative care unit (PACU), in the first 30 minutes after surgery, in the 2nd hour after surgery, in the 6th hour after surgery, in the 12th hour after surgery,
at the 24th hour after surgery

- Pain assessment will be performed face to face in the thoracic surgery intensive care unit or ward.
Secondary outcome [1] 423240 0
The inspiratory spirometry (triflow) test will be performed and the inspiratory flow rate calculated according to the number of rising balls will be recorded (1 ball = 600 ml, 2 balls = 900 ml, 3 balls = 1200 ml).
Timepoint [1] 423240 0
- In the postoperative care unit (PACU), in the first 30 minutes after surgery, in the 2nd hour after surgery, in the 6th hour after surgery, in the 12th hour after surgery,
at the 24th hour after surgery

- - Triflow rate assessment will be performed face to face in the thoracic surgery intensive care unit or ward.
Secondary outcome [2] 423243 0
Postoperative nausea and/or vomiting (PONV) will be evaluated in patients.
Timepoint [2] 423243 0
- In the postoperative care unit (PACU), in the first 30 minutes after surgery, in the 2nd hour after surgery, in the 6th hour after surgery, in the 12th hour after surgery,
at the 24th hour after surgery

- The evaluation data will be obtained from hospital medical records and nurse follow-up forms.
Secondary outcome [3] 423244 0
Amount of fentanyl used intraoperatively (µg)
Timepoint [3] 423244 0
- during surgery

- data will be obtained from hospital medical records.
Secondary outcome [4] 423245 0
Amount of tramadol used postoperatively (mg)
Timepoint [4] 423245 0
- during the postoperative 24 hours

- evaluation data will be obtained from hospital medical records.
Secondary outcome [5] 423246 0
- Surgery duration (hours)
Timepoint [5] 423246 0
- at the end of surgery

- data will be obtained from hospital medical records
Secondary outcome [6] 423247 0
Anesthesia duration (hours)
Timepoint [6] 423247 0
-at the end of anaesthesia

- data will be obtained from hospital medical records
Secondary outcome [7] 423248 0
Length of stay in intensive care (days)
Timepoint [7] 423248 0
- on discharge from the intensive care unit
- data will be obtained from hospital medical records
Secondary outcome [8] 423249 0
Length of hospital stay (days)
Timepoint [8] 423249 0
- on discharge from the hospital
- data will be obtained from hospital medical records

Eligibility
Key inclusion criteria
Volunteer patients aged 18-70 years, American Society of Anesthesiologists (ASA) I-III physical status, who were to undergo thoracotomy were included in the study.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with infection in the application area, coagulation disorder, morbid obesity (Body Mass Index (BMI > 35), drug allergy, chronic pain history, long-term opioid use, psychiatric disease history, emergency operations and patients who did not agree to participate in the study were excluded from the 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)
central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised 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
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
- The sample size calculation for the study was performed using an analysis (G*Power 3.1.9.4 software, Kiel University, Kiel, Germany). The parameters used in the calculation were a two-tailed alpha error of 0.05, a power of 0.80, and an effect size of 0.80. Based on a prior study and considering the allocation ratio of N2/N1 as 1, the minimum required number of patients for inclusion in the study was determined to be 42.

- Statistical analyses were conducted using SPSS 16.0 for Windows (SPSS Inc., Chicago, IL, USA). Descriptive statistics were used to express the numerical data as mean and standard deviation, while categorical data were presented as frequency and percentage. The Chi-square test was employed to compare categorical data between groups, with the results reported as percentages (n%). The Shapiro-Wilk test was utilized to assess the normality of the numerical data. For normally distributed data, Student's t-test was employed for evaluation, while the Mann-Whitney U test was used for non-normally distributed data comparison. A significance level of p < 0.05 was considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/08/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
42
Accrual to date
Final
Recruitment outside Australia
Country [1] 25602 0
Turkey
State/province [1] 25602 0
Diyarbakir

Funding & Sponsors
Funding source category [1] 314124 0
Hospital
Name [1] 314124 0
TR HSU Diyarbakir Gazi Yasargil TRH
Country [1] 314124 0
Turkey
Primary sponsor type
University
Name
Health Sciences University Training and Research Hospital
Address
Mekteb-i Tibbiye-i Sahane (Hamidiye) Külliyesi Selimiye Mah. Tibbiye Cad. No:38 34668 Üsküdar, Istanbul
Country
Turkey
Secondary sponsor category [1] 316039 0
Individual
Name [1] 316039 0
Fatma Acil
Address [1] 316039 0
Elazig Yolu 10. Km Üçkuyular Mevkii, zip code: 21070, Kayapinar/Diyarbakir
Country [1] 316039 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313260 0
TR HSU Diyarbakir Gazi Yasargil TRH Ethic Committee
Ethics committee address [1] 313260 0
Ethics committee country [1] 313260 0
Turkey
Date submitted for ethics approval [1] 313260 0
18/07/2022
Approval date [1] 313260 0
21/10/2022
Ethics approval number [1] 313260 0
216

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

Contacts
Principal investigator
Name 127514 0
Dr Fatma Acil
Address 127514 0
TR HSU Diyarbakir Gazi Yasargil TRH, Elazig Yolu 10. Km Üçkuyular Mevkii, zip code: 21070, Kayapinar/Diyarbakir
Country 127514 0
Turkey
Phone 127514 0
+905337225225
Fax 127514 0
Email 127514 0
[email protected]
Contact person for public queries
Name 127515 0
Fatma Acil
Address 127515 0
TR HSU Diyarbakir Gazi Yasargil TRH, Elazig Yolu 10. Km Üçkuyular Mevkii, zip code: 21070, Kayapinar/Diyarbakir
Country 127515 0
Turkey
Phone 127515 0
+905337225225
Fax 127515 0
Email 127515 0
[email protected]
Contact person for scientific queries
Name 127516 0
Osman Uzundere
Address 127516 0
TR HSU Diyarbakir Gazi Yasargil TRH, Elazig Yolu 10. Km Üçkuyular Mevkii, zip code: 21070, Kayapinar/Diyarbakir
Country 127516 0
Turkey
Phone 127516 0
+905330206362
Fax 127516 0
Email 127516 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
after de-identification; individual participant data underlying published results only
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
only to achieve the aims in the approved proposal and for IPD meta-analyses
How or where can data be obtained?
access subject to approvals by Principal Investigator (email: [email protected])


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.