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Trial registered on ANZCTR


Registration number
ACTRN12619000044123
Ethics application status
Approved
Date submitted
13/12/2018
Date registered
14/01/2019
Date last updated
7/07/2020
Date data sharing statement initially provided
14/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Erector spinae plane block for perioperative analgesia after percutaneous nephrolithotomy
Scientific title
Erector spinae plane block for perioperative analgesia after percutaneous nephrolithotomy
Secondary ID [1] 295424 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
urolithiasis 308677 0
Condition category
Condition code
Renal and Urogenital 307606 307606 0 0
Kidney disease
Surgery 307607 307607 0 0
Other surgery
Anaesthesiology 307608 307608 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Anesthesia: Standard monitoring procedures include pulse oximetry, electrocardiography, and noninvasive arterial pressure performed prior to anesthesia. Baseline heart rates, systolic and diastolic blood pressures and mean arterial pressures are recorded before anesthesia. All patients will be given antibiotic prophylaxis, according to the hospital's protocol. Induction will be performed using bolus of propofol 2mg/kg intravenously , bolus of fentanyl 100 µg intravenously and bolus of rocuronium bromide 0,6 -0,8 mg/kg intravenously 0,8 -1,2 MAC sevoflurane via endotracheal tube. and 0,08 µg/kg/min remifentanil intravenously infusion will be used for anesthesia maintenance. Remifentanil dosage will be adjusted according to hemodynamic parameters, up to 2 µg/kg/min. After completion of surgery, patients are extubated when adequate muscle strength is established, and they are transferred to the recovery room. Local anesthesia will not be applied to wounds.
Each patient will receive patient controlled analgesia (PCA) pump (nalbuphine) and 1 g of paracetamolum intravenously every 6 hours as standard postoperative pain treatment. If VAS scale exceeds 4 in any measure, in addition, dexketoprofen 50 mg intravenously every 8 hours will be given.
All medications exept nalbuphine are administered by anesthesiologist nurse.

ESPB: All blocks will be performed under sedoanalgesia and before general anesthesia induction. Following routine monitoring and premedication the patients will be placed in the sitting position. ESPB is performed under ultrasonographic guidance. The linear ultrasound transducer is placed in a longitudinal parasagittal orientation 3 cm lateral to the T7 spinous process. The erector spinae muscles are identified superficial to the tip of the T7 transverse process. The patient's skin is anesthetized with 3mL of 2% lidocaine subcutaneously. The tip of the 22G needle is placed into the fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip is confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging of the transverse process on ultrasonographic imaging. A total of 20mL of 0.5% bupivacaine will be injected to this site. In addition dexamethasone 0,1 mg/kg intravenously is administered.
This block is performed by anaethesiologist.

PCNL: All patients qualified for PCNL had contrast-enhanced computed tomography performed before surgery. Briefly, we operate patients in prone position with utilization of Amplatz dilators and sheaths. Patients are operated in general anesthesia. Perioperatively 1,5 g cephalosporin 2nd (Cefuroxime) generation intravenously is used as antibiotic prophylaxis . Puncture and tract formation is done by urologist under fluoroscopic guidance. We use 26 Fr nephroscope with ultrasound as well as pneumatic lithotripter to disintegrate the stone. At the end of PCNL re-entry Malecot (16Fr) nephrostomy is inserted and maintained for 4 days.
PCNL is performed by urologist. The procedure lasts for approximately 90-120 minutes.

Intervention: Patients will be divided into two groups. First group (n=35) will comprise patients where only PCA + paracetamolum is used for postoperative analgesia while patients in the second group (n=35) will receive ESPB and PCA + paracetamolum. Rescue analgesia with dexketoprofen 50 mg every 8 hours will be administered when VAS > 4 in any measurement in any group.
Intervention code [1] 301732 0
Treatment: Surgery
Intervention code [2] 301733 0
Treatment: Other
Comparator / control treatment
Intervention: Patients will be divided into two groups. First group (n=35) will comprise patients where only PCA + paracetamolum is used for postoperative analgesia while patients in the second group (n=35) will receive ESPB and PCA + paracetamolum. Rescue analgesia with dexketoprofen 50 mg every 8 hours will be administered when VAS > 4 in any measurement in any group.
Control group
Active

Outcomes
Primary outcome [1] 306584 0
visual analogue scale of pain assessed 6 times postoperatively (cm)
Timepoint [1] 306584 0
in 1, 2, 4, 6, 12 and 24 hours postoperatively
Secondary outcome [1] 348944 0
nalbuphine consumption (mg) . One syringe with 40 mg nalbuphine is used with the PCA pump. Each syringe exchange is marked by the nurse. After 24 hour period all syringes and the amount of the remaining medication in the last syringe are summarized and information is given to the doctor.
Timepoint [1] 348944 0
in 24 hour postoperative period
Secondary outcome [2] 348945 0
need for additional pain medications (if VAS >4) (yes/no) . Patient marks the VAS of pain which he holds for the 24 hour period postoperatively. And the scale is asessed by the nurse.
Timepoint [2] 348945 0
in 24 hour postoperative period
Secondary outcome [3] 348946 0
side effects (nausea, vomiting, convulsions) (yes/no). This outcome is assessed by direct observation of the patient by the nurse every two hours.
Timepoint [3] 348946 0
in 24 hour postoperative period
Secondary outcome [4] 348947 0
mean arterial pressure (mmHg). This outcome is assessed with sphygmomanometer by the nurse every two hours
Timepoint [4] 348947 0
in 1, 2, 4, 6, 12 and 24 hours postoperatively
Secondary outcome [5] 352060 0
sedation Ramsey scale (points)
Timepoint [5] 352060 0
in 1, 2, 4, 6, 12 and 24 hours postoperatively

Eligibility
Key inclusion criteria
a. Patients who gave informed consent for participation in the study
b. Age 18-70 years
c. ASA I-III
d. Patients with BMI < 35
e. Patients with kidney stone over 2 cm in diameter or patients with kidney stones 1 - 2 cm who wished to have PCNL instead of retrograde intrarenal surgery or shockwave lithotripsy (SWL)
or patients with kidney stones 1 - 2 cm with contraindications for SWL
f. Single access PCNL
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. Residual stones after surgery and need for a second look
b. Bleeding diathesis
c. Solitary kidney
d. Dermal infection in injection site
e. Contrast and drug allergy
f. Routine antidepressants, corticosteroids, pain medications, anticonvulsants use
g. Massive bleeding during operation which requires clamping the nephrostomy or open surgery
h. Need to apply other pain medications or neuroleptics postoperatively

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)
simple randomization (random shuffling). Closed opaque envelopes with information inside about the type of perioperative analgesia (ESPB or NO ESPB)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
ANOVA with repeated measures analysis for primary endpoint

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/01/2019
Actual
22/01/2019
Date of last participant enrolment
Anticipated
30/05/2020
Actual
28/04/2020
Date of last data collection
Anticipated
31/05/2020
Actual
29/04/2020
Sample size
Target
75
Accrual to date
Final
75
Recruitment outside Australia
Country [1] 10609 0
Poland
State/province [1] 10609 0
Silesia

Funding & Sponsors
Funding source category [1] 300012 0
Self funded/Unfunded
Name [1] 300012 0
Country [1] 300012 0
Primary sponsor type
Individual
Name
Piotr Bryniarski
Address
Department of Urology in Zabrze, Medical University of Silesia in Katowice, 3 Maja Street 13-15, 41-800 Zabrze,
Country
Poland
Secondary sponsor category [1] 299398 0
None
Name [1] 299398 0
None
Address [1] 299398 0
None
Country [1] 299398 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300865 0
Ethics Committee of Medical University of Silesia
Ethics committee address [1] 300865 0
Ethics committee country [1] 300865 0
Poland
Date submitted for ethics approval [1] 300865 0
25/09/2018
Approval date [1] 300865 0
30/10/2018
Ethics approval number [1] 300865 0
KNW/0022/KB1/70/I/18

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

Contacts
Principal investigator
Name 85082 0
Dr Piotr Bryniarski
Address 85082 0
3 Maja street 13-15, 41-800 Zabrze. Work organisation: Independent Public Clinical Hospital no 1 in Zabrze. and Medical University of Silesia in Katowice.
Country 85082 0
Poland
Phone 85082 0
0048 323704440
Fax 85082 0
0048 323704440
Email 85082 0
piotr.bryniarski@hotmail.com
Contact person for public queries
Name 85083 0
Piotr Bryniarski
Address 85083 0
3 Maja street 13-15, 41-800 Zabrze. Work organisation: Independent Public Clinical Hospital no 1 in Zabrze. and Medical University of Silesia in Katowice.
Country 85083 0
Poland
Phone 85083 0
0048 323704440
Fax 85083 0
0048 323704440
Email 85083 0
piotr.bryniarski@hotmail.com
Contact person for scientific queries
Name 85084 0
Piotr Bryniarski
Address 85084 0
3 Maja street 13-15, 41-800 Zabrze. Work organisation: Independent Public Clinical Hospital no 1 in Zabrze. and Medical University of Silesia in Katowice.
Country 85084 0
Poland
Phone 85084 0
0048 323704440
Fax 85084 0
0048 323704440
Email 85084 0
piotr.bryniarski@hotmail.com

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6137Study protocol  piotr.bryniarski@hotmail.com
6138Informed consent form  piotr.bryniarski@hotmail.com
6139Ethical approval  piotr.bryniarski@hotmail.com



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseErector spinae plane block for perioperative analgesia after percutaneous nephrolithotomy.2021https://dx.doi.org/10.3390/ijerph18073625
N.B. These documents automatically identified may not have been verified by the study sponsor.