Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000580471
Ethics application status
Approved
Date submitted
14/04/2025
Date registered
4/06/2025
Date last updated
8/06/2025
Date data sharing statement initially provided
4/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing pain relief with and without magnesium sulfate in a nerve block for patients having chest surgery.
Scientific title
The effect of adding magnesium sulfate to bupivacaine in paravertebral block in patients undergoing thoracotomy.
Secondary ID [1] 314201 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain managment 337097 0
Condition category
Condition code
Anaesthesiology 333514 333514 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will include 60 consecutive patients or the available number of patients meeting the inclusion criteria within a period of 2 years scheduled for elective thoracotomy under general anesthesia, with ASA status I, II, or III. General anesthesia will approximately last 2-3 hours.. Demographic and clinical data will be collected using a standardized form. The exclusion criteria are: age under 18 years, allergy to any of the drugs used, infection at the block site, spinal deformity, existing coagulation disorders, patient refusal to provide informed consent, as well as morbid obesity (body mass index >40).
Patients will be randomized into two groups (trial and control) using a random number generator. Both groups will receive general endotracheal anesthesia performed by an experienced anesthesiologist (defined as more than 10 years of clinical experience).
All patients will be informed of the risks and benefits of the procedure during the preoperative visit, one day before surgery, and will be asked to sign informed consent.
The paravertebral block will be performed in a designated anesthetic induction room adjacent to the operating theatre, equipped with all mandatory monitoring equipment including ECG, non-invasive blood pressure, pulse oximetry, and oxygen delivery systems. Prior to induction of general anesthesia, patients will undergo an ultrasound-guided paravertebral block (PVB) approximately 30 minutes before induction of anesthesia.. Trial group will receive a mixture of 13.5 mL 0.5% bupivacaine and 150 mg (1mL=50mg) magnesium sulfate (total volume 15 mL), while control group will receive 13.5 mL 0.5% bupivacaine and 1.5 mL of 0.9% saline.
On the day of surgery, after admission to the preoperative area, intravenous access will be established and blood samples collected for baseline laboratory values. Patients will then be positioned sitting with their back and neck flexed forward for PVB administration. Under ultrasound guidance, the spinous processes of vertebrae Th4, Th5, and Th6, as well as the corresponding ribs and paravertebral spaces, will be identified. A linear ultrasound transducer will be placed longitudinally along the paravertebral spaces, lateral to the midline, oriented cranially. The transducer will be moved medially until rounded ribs and the parietal pleura are visualized. After identifying the desired paravertebral space, a 25G needle will be inserted using the out-of-plane technique under strict aseptic conditions. After confirming negative aspiration for blood or air, a total of 5mL of the LA mixture will be administered in 3 paravertebral spaces between Th4-Th7.
Following the PVB, a "pinprick" test will be used to assess the extent of sensory block, and the onset of analgesia will be recorded (defined as a reduction in pinprick and cold sensation (tested with an alcohol-soaked cotton swab) of at least 75%).
Before induction of general anesthesia, standard monitoring will be applied (ECG, non-invasive blood pressure, SpO2), and a radial arterial line will be placed on the opposite side of the thoracotomy for continuous blood pressure monitoring.
During surgery, participants will be monitored by the anesthesiology attending. Postoperatively, monitoring will be continued in the ICU by the attending anesthesiologist.
General anesthesia will be identical in both groups. Induction will be achieved with intravenous propofol (1.5–2.5 mg/kg), sufentanil (0.2 µg/kg), and rocuronium (0.6 mg/kg). Patients will be intubated with a double-lumen endotracheal tube. Maintenance will be with sevoflurane in an oxygen/air mixture. Mechanical ventilation parameters will include tidal volume 6–8 mL/kg, PEEP 5 cm H2O, and end-tidal CO2 maintained between 30–35 mmHg.
Throughout the surgery, invasive blood pressure will be monitored continuously, with systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and heart rate (HR) recorded every 5 minutes.
At the end of anesthesia, prior to extubation, neuromuscular blockade will be reversed with 2.5 mg neostigmine and 1 mg atropine.
Postoperative pain will be assessed using the Numerical Pain Rating Scale (NPRS) at rest and during coughing every 2 hours after surgery. Time to first report of pain (defined as NPRS >=1) will be recorded. For NPRS scores of 1–3, patients will receive 1 g IV paracetamol; for scores 4–10 sufentanil will be administered in incremental boluses of 10 mcg until an NPRS <= 3 is achieved. Total analgesic consumption within the first 24 hours will be recorded and converted to morphine equivalent doses.
Blood samples for calculating neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and monocyte-to-lymphocyte ratio (MLR) will be collected at three time points: preoperatively, and at 6 and 24 hours postoperatively. These biomarkers will be analyzed for their potential association with postoperative pain intensity and analgesic requirements.
Fidelity to the intended procedures will be maintained by following a standardized protocol checklist at each step of patient care, direct supervision of all procedures by experienced anesthesiology attendings, and regular data audits conducted by the study’s research coordinator."
Intervention code [1] 330807 0
Treatment: Drugs
Comparator / control treatment
The control group will receive a paravertebral block with 13.5 mL of 0.5% bupivacaine combined with 1.5 mL of 0.9% saline (total volume 15 mL). The block will be administered under ultrasound guidance using the same technique as the trial group, with 5 mL injected into each of three paravertebral spaces (between Th4–Th7).
Control group
Active

Outcomes
Primary outcome [1] 341091 0
Time to first pain: hours from block to first NPRS =>1.
Timepoint [1] 341091 0
Within the first 24 hours postoperatively
Secondary outcome [1] 446206 0
Total postoperative opioid consumption.
Timepoint [1] 446206 0
Within the first 24 hours postoperatively
Secondary outcome [2] 446209 0
Pain assessment.
Timepoint [2] 446209 0
At three time points: preoperatively, 6 hours postoperatively, and 24 hours postoperatively.
Secondary outcome [3] 446210 0
Pain assessment
Timepoint [3] 446210 0
At three time points: preoperatively, 6 hours postoperatively, and 24 hours postoperatively.
Secondary outcome [4] 446211 0
Pain assessment
Timepoint [4] 446211 0
At three time points: preoperatively, 6 hours postoperatively, and 24 hours postoperatively.

Eligibility
Key inclusion criteria
ASA I, II and III status. Elective thoracotomy surgery.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age under 18 years, allergy to any of the drugs used, infection at the block site, spinal deformity, existing coagulation disorders, patient refusal to provide informed consent, as well as morbid obesity (body mass index >40).

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 randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
12/06/2027
Actual
Date of last data collection
Anticipated
13/06/2027
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 26976 0
Croatia
State/province [1] 26976 0

Funding & Sponsors
Funding source category [1] 318718 0
Hospital
Name [1] 318718 0
University Hospital Center Sestre milosrdnice
Country [1] 318718 0
Croatia
Primary sponsor type
Hospital
Name
University Hospital Center Sestre milosrdnice
Address
Country
Croatia
Secondary sponsor category [1] 321151 0
None
Name [1] 321151 0
Address [1] 321151 0
Country [1] 321151 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317329 0
Ethics Committee of University Hospital Center Sestre milosrdnice
Ethics committee address [1] 317329 0
Ethics committee country [1] 317329 0
Croatia
Date submitted for ethics approval [1] 317329 0
21/04/2025
Approval date [1] 317329 0
13/05/2025
Ethics approval number [1] 317329 0
251-29-11/3-25-12

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

Contacts
Principal investigator
Name 140702 0
Dr Stipe Salaj
Address 140702 0
UHC Sestre milosrdnice, Vinogradska c. 29, 10000 Zagreb
Country 140702 0
Croatia
Phone 140702 0
+385993787276
Fax 140702 0
Email 140702 0
[email protected]
Contact person for public queries
Name 140703 0
Stipe Salaj
Address 140703 0
UHC Sestre milosrdnice, Vinogradska c. 29, 10000 Zagreb
Country 140703 0
Croatia
Phone 140703 0
+385993787276
Fax 140703 0
Email 140703 0
[email protected]
Contact person for scientific queries
Name 140704 0
Stipe Salaj
Address 140704 0
UHC Sestre milosrdnice, Vinogradska c. 29, 10000 Zagreb
Country 140704 0
Croatia
Phone 140704 0
+385993787276
Fax 140704 0
Email 140704 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    Stipe Salaj, dr. med..pdf


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.