Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000869774
Ethics application status
Approved
Date submitted
24/05/2022
Date registered
20/06/2022
Date last updated
20/06/2022
Date data sharing statement initially provided
20/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Robot-assisted radical prostatectomy: comparison of subarachnoid analgesia, erector spine plane block, and intravenous analgesia for postoperative pain management.
Scientific title
Comparison of subarachnoid analgesia, erector spine plane block, and intravenous analgesia for pain management after robot -assisted prostatectomy
Secondary ID [1] 307191 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative pain after robot-assisted radical prostatectomy 326416 0
Prostate cancer 326586 0
Condition category
Condition code
Anaesthesiology 323700 323700 0 0
Pain management
Surgery 323829 323829 0 0
Other surgery
Cancer 323830 323830 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group SUB: Subarachnoid analgesia (administered once only immediately before the general anesthesia) using 10.5 mg ropivacaine 0.75%, 30 mcg clonidine150 mcg/mL, 2 mcg/Kg morphine 100 mcg/mL and 0.03 mcg/Kg sufentanil 5 mcg/mL with a sterile 27 G needle at the L1-L2 or L2-L3 interspace. Thirty minutes before the end of the surgery, patients will be treated with a single intravenous bolus only of 1g of paracetmol and 30mg of ketorolac and a continuous intravenous infusion of 45 mg/day ketorolac and 1 mcg/Kg/day clonidine started immediately after the bolus of paracetamol and ketorolac and administered over the 48 hour postoperative period. We will monitor the adherence to the intervention through audit of medication charts.
Group ESP: before the general anesthesia, patients will undergo bilateral ultrasound-guided in-plane erector spinae plane (ESP) block performed once only per side, placing the needle between the erector spinae muscle and the transverse process of the T10 or T11 vertebra and injecting, for each side, 30 mcg clonidine, 4 mg dexamethasone, 100 mg ropivacaine (total volume 20 ml). In these patients a single intravenous bolus only of 1g of paracetamol and 30mg of ketorolac was given 30 minutes before the end of the surgery and a continuous intravenous infusion with 45 mg/day ketorolac and 1 mcg/Kg/day clonidine, starting immediately after the bolus of paracetamol and ketorolac, was administered over the 48 hour postoperative period. We will monitor the adherence to the intervention through audit of medication charts.
Intervention code [1] 323641 0
Treatment: Drugs
Comparator / control treatment
Group IV: patients will receive 10 mg intramuscular morphine once only 30 minutes before the end of the surgery along with a single intravenous bolus only of 1g of paracetamol and 30mg of ketorolac and they will be treated with a continuous intravenous infusion of 15 mg/day morphine, 45 mg/day ketorolac and 1 mcg/Kg/day clonidine in the 48 hour postoperative period starting immediately after the bolus of paracetamol and ketorolac. We will monitor the adherence to the intervention through audit of medication charts.
Control group
Active

Outcomes
Primary outcome [1] 331459 0
Pain measured with numeric rating scale (NRS).
Timepoint [1] 331459 0
Every 15 minutes for the first hour postoperatively, and at 3, 6, 12 (primary endpoint), 24, and 48 hours post-surgery.
Secondary outcome [1] 409974 0
Bladder spasm assessed by a patient self reported 5 Likert scale: 1-no spasm; 2-mild; 3-moderate; 4- severe; 5- intolerable.
Timepoint [1] 409974 0
12 hours post-surgery
Secondary outcome [2] 409975 0
Intraoperative opioids consumption evaluated by accessing medication charts.
Timepoint [2] 409975 0
End of the surgery
Secondary outcome [3] 409976 0
Time between the end of surgery and the request for the first additional dose of analgesic determined by accessing medication charts
Timepoint [3] 409976 0
First 48 hours after surgery
Secondary outcome [4] 409977 0
Time to mobilization assessed by accessing nursing notes
Timepoint [4] 409977 0
First 48 hours after surgery
Secondary outcome [5] 409978 0
Patient satisfaction assessed by a 5-point Likert scale: 1-not at all satisfied; 2- poorly; 3- moderately satisfied; 4-satisfied; 5-very satisfied.
Timepoint [5] 409978 0
3, 6, 12, 24, 48 hours after surgery

Eligibility
Key inclusion criteria
Age greater than or equal to 18 years; American Society of Anesthesiologists (ASA) physical status I-III; Body Mass Index (BMI) < 35 kg/m2; diagnosis of prostate cancer.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Severe respiratory and cardiovascular deficits; neuromuscular deficits (such as S. Guillain-Barrè, SLA, myasthenia gravis, muscular dystrophy); Renal Failure (Creatinine Clearance < 60 mL/min/1,73m2); Liver Failure (Child-Pugh Score B and C); allergy to study medication; contra-indications to spinal anesthesia (such as severe valvular hearth disease, increased intracranial pressure, coagulation disorders, sepsis, patient refusal)

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 computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation will be performed by a random sequence of numbers generated by a computer
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be first analyzed with Shapiro test to assess the normal distribution. Parametric data will be presented as mean and standard deviation (SD), whereas non parametric data as median and interquartile range (IQR). Statistical analysis will be performed through analysis of variance (ANOVA) for parametric data and Kruskal-Wallis test for non parametric data; ANOVA post hoc analysis will be performed with Tukey test, whereas Kruskal-Wallis post hoc analysis will be performed with Dunn test. Differences will be considered statistically significant when p<0.05.
We determined the sample size assuming alpha=0.05, beta=0.10, and, a standard deviation of 2 in order to detect a difference in NRS at 12 hours after intervention of 1 point; we estimated a sample size of 16 patients for each of the three groups. We enrolled 20 patients per group, considering a potential 20% drop out rate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/06/2022
Actual
Date of last participant enrolment
Anticipated
12/08/2022
Actual
Date of last data collection
Anticipated
14/08/2022
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 24789 0
Italy
State/province [1] 24789 0

Funding & Sponsors
Funding source category [1] 311497 0
Hospital
Name [1] 311497 0
Azienda Ospedaliera Universitaria -Federico II
Country [1] 311497 0
Italy
Primary sponsor type
Individual
Name
Pasquale Buonanno
Address
Azienda Ospedaliera Universitaria-Federico II
Via Sergio Pansini, 5 80131 Neaples
Country
Italy
Secondary sponsor category [1] 312897 0
Individual
Name [1] 312897 0
Nicola Logrieco
Address [1] 312897 0
Azienda Ospedaliera Universitaria-Federico II
Via Sergio Pansini, 5 80131 Neaples
Country [1] 312897 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310957 0
Comitato Etico Università Federico II
Ethics committee address [1] 310957 0
Ethics committee country [1] 310957 0
Italy
Date submitted for ethics approval [1] 310957 0
27/11/2021
Approval date [1] 310957 0
12/01/2022
Ethics approval number [1] 310957 0
307/21

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

Contacts
Principal investigator
Name 119494 0
Dr Pasquale Buonanno
Address 119494 0
Azienda Ospedaliera Universitaria-Federico II
Via Sergio Pansini 5 80131 Neaples
Country 119494 0
Italy
Phone 119494 0
+390817463552
Fax 119494 0
Email 119494 0
[email protected]
Contact person for public queries
Name 119495 0
Pasquale Buonanno
Address 119495 0
Azienda Ospedaliera Universitaria-Federico II
Via Sergio Pansini 5 80131 Neaples
Country 119495 0
Italy
Phone 119495 0
+390817463552
Fax 119495 0
Email 119495 0
[email protected]
Contact person for scientific queries
Name 119496 0
Pasquale Buonanno
Address 119496 0
Azienda Ospedaliera Universitaria-Federico II
Via Sergio Pansini 5 80131 Neaples
Country 119496 0
Italy
Phone 119496 0
+390817463552
Fax 119496 0
Email 119496 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?
All the demographic data and the outcomes measured without limitations
When will data be available (start and end dates)?
Data will be available after publication with no end date.
Available to whom?
To qualified researchers for scientific purposes
Available for what types of analyses?
For articles to be published in international scientific journal
How or where can data be obtained?
Data can be requested by email to the Principal investigator (Pasquale Buonanno, [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.