Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001435774p
Ethics application status
Not yet submitted
Date submitted
22/10/2022
Date registered
9/11/2022
Date last updated
9/11/2022
Date data sharing statement initially provided
9/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Postoperative analgesia in robot assisted nephrectomy: a comparitve study.
Scientific title
Robot assisted nephrectomy: comparison between subarachnoid analgesia, Transversus Abdominis Plane block associated to Quadratus Lumborum Block and intravenous analgesia in postoperative pain control.
Secondary ID [1] 308042 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative pain in robot assisted nephrectomy 327730 0
Kidney cancer 327744 0
Condition category
Condition code
Anaesthesiology 324798 324798 0 0
Pain management
Cancer 324816 324816 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group TQ: After the tracheal intubation transversus abdominis plane block (TAP block) and Quadratus Lumborum Blocks type 1 and 2 will be performed by an anaesthesist of the study team with ultrasound guidance using an in-plane technique. In the subcostal and posterior TAP-Block + Quadratus Lumborum Block type 1 the posterior abdominal wall will be infiltrated once only with an anesthetic mixture of ropivacaine 75 mg, clonidine 30 mcg, dexamethasone 2 mg, in a total volume of 20 ml. In the Quadratus Lumborum Block type 2, the anesthetic mixture is injected into the posterior segment of the Quadratus Lumborum muscle under ultrasound guidance. In the type 3 block, on the other hand, the needle is positioned between the Quadratus Lumborum muscle and the psoas muscle fascia at the level of L4 transverse process. For each block (performed at the side of intervention) an anesthetic mixture of ropivacaine 50 mg clonidine 15 mcg, dexamethasone 2 mg, in a total volume of 15 ml per block will be injected.
GROUP S: Before general anesthesia, a subarachnoid analgesia will be performed by an anaesthesist of the study team using a 27 G Whitacre needle, in L1-L2 or L2-L3 intervertebral spaces, using:10 mg of ropivacaine, 0,4 µg/kg (ideal weight) of Clonidine 150µg/ml, 2 µg/kg (ideal weight) of morphine 100µg/ml, 0,02 µg/kg (ideal weight) of sufentanil 5 µg/ml in a total volume of 5 ml of saline.

The following parameters will be evaluated right after the recovery from general anesthesia (T0) and at 3, 6, 12, 24,and 48 hours (T3, T6, T12, T24, T48, respectively) from the end of the intervention: static and dynamic NRS, bladder spasms evaluated with a 5 points Likert scale, opioids side effects (nausea, vomiting, dizziness, sedation, itching). We will also record the time between the end of the surgery and the request for the first analgesic additional dose, the number of additional analgesic doses in the first postoperative 48 hours, the possible occurrence of side effects related to the performed procedures, the time between the recovery of gut motility and patient's ability to autonomously walk; we will also evaluate the length of hospital stay and the degree of patient's satisfaction measured with a 5 point Likert scale.

STUDY DURATION TIME: 6 months.
Intervention code [1] 324704 0
Treatment: Other
Intervention code [2] 324824 0
Treatment: Drugs
Comparator / control treatment
Group IV: patients will receive 5mg of intramuscular morphine once only and 1g of intravenous paracetamol once only 30 minutes before the end of the surgery immediately followed by a continuous intravenous infusion of of morphine 10mg and clonidine 1mcg/kg in the first 24 hours. We will monitor the adherence to the intervention through audit of medication charts. Surgical wound will be infiltrated with 20ml of ropivacaine 2mg/ml. Rescue medications will be administered in the following order if pain (measured with numeric rating scale, NRS) is equal or more than 4: paracetamol 1g intravenous once only and, if the pain persists, 2mg of intravenous morphine every 15 minutes up to a maximum total dose of 10mg to reach a NRS lower than 4.
Control group
Active

Outcomes
Primary outcome [1] 332629 0
Pain measured with numeric rating scale (NRS).
Timepoint [1] 332629 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] 414125 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] 414125 0
Right after the recovery from general anesthesia (T0) and at 3, 6, 12, 24,and 48 hours (T3, T6, T12, T24, T48, respectively) from the end of the intervention.
Secondary outcome [2] 415002 0
Time to mobilization assessed by accessing nursing notes
Timepoint [2] 415002 0
First 48 hours after surgery
Secondary outcome [3] 415003 0
Intraoperative opioids consumption evaluated by accessing medication charts
Timepoint [3] 415003 0
End of the surgery
Secondary outcome [4] 415004 0
Time between the end of surgery and the request for the first additional dose of analgesic determined by accessing medication charts
Timepoint [4] 415004 0
First 48 hours after surgery
Secondary outcome [5] 415005 0
Total amount of postoperative additional analgesic drugs; this information will be collected from the medication charts
Timepoint [5] 415005 0
First postoperative 48 hours
Secondary outcome [6] 415006 0
Time to recovery gut motility; this information will be collected by nursing notes.
Timepoint [6] 415006 0
First 48 hours after surgery
Secondary outcome [7] 415007 0
Length of hospital stay; these data will be collected from medical records
Timepoint [7] 415007 0
First 72 hours after surgery
Secondary outcome [8] 415008 0
Patient's satisfaction measured by a 5-point Likert scale
Timepoint [8] 415008 0
First 48 hours after surgery

Eligibility
Key inclusion criteria
Age > 18 years
ASA I-III
Body Mass Index between 18.5 and 35 kg/m2
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe respiratory or cardiovascular deficits
Neuromuscular Deficit (such as Muscular Dystrophies, Myasthenia Gravis, Guillain-Barrè Syndrome, Amyotrophic lateral sclerosis)
Renal failure (creatinine clearance <30mL/min/1,73m2)
Hepatic Failure (Child-Pugh score B and C)
Psychiatric disorders
Allergy or hypersensitivity to drugs used in our protocol
Absolute contraindication to subarachnoid anesthesia (patient refuse, congenital or acquired coagulopathy, surgical site infection, clinically relevant valvular diseases, increased intracranial pressure, severe hypovolemia, sepsis).
Psychotropic drugs ongoing therapy
Chronic therapy with opioids
Concomitant participation to other scientific studies
Incapability to understand risks connected to the study or to provide informed consent

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
1/12/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 25019 0
Italy
State/province [1] 25019 0

Funding & Sponsors
Funding source category [1] 312300 0
Hospital
Name [1] 312300 0
Azienda Ospedaliera Universitaria -Federico II
Country [1] 312300 0
Italy
Primary sponsor type
Individual
Name
Pasquale Buonanno
Address
University Hospital "Federico II" Via Sergio Pansini 5, 80131, Neaples
Country
Italy
Secondary sponsor category [1] 313851 0
Individual
Name [1] 313851 0
Nicola Logrieco
Address [1] 313851 0
University hospital "Federico II" Via Sergio Pansini, 5 80131, Neaples
Country [1] 313851 0
Italy

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 311669 0
Comitato Etico Università Federico II
Ethics committee address [1] 311669 0
Ethics committee country [1] 311669 0
Italy
Date submitted for ethics approval [1] 311669 0
15/11/2022
Approval date [1] 311669 0
Ethics approval number [1] 311669 0

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

Contacts
Principal investigator
Name 121930 0
Dr Pasquale Buonanno
Address 121930 0
University hospital "Federico II" Via Pansini 5, 80131, Naples
Country 121930 0
Italy
Phone 121930 0
+390817463552
Fax 121930 0
Email 121930 0
[email protected]
Contact person for public queries
Name 121931 0
Pasquale Buonanno
Address 121931 0
University hospital "Federico II" Via Pansini 5, 80131, Naples
Country 121931 0
Italy
Phone 121931 0
+390817463552
Fax 121931 0
Email 121931 0
[email protected]
Contact person for scientific queries
Name 121932 0
Pasquale Buonanno
Address 121932 0
University hospital "Federico II" Via Pansini 5, 80131, Naples
Country 121932 0
Italy
Phone 121932 0
+390817463552
Fax 121932 0
Email 121932 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
Privacy matters


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.