Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001206819
Ethics application status
Approved
Date submitted
16/07/2021
Date registered
9/09/2021
Date last updated
9/09/2021
Date data sharing statement initially provided
9/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical effectiveness of erector spinae catheters in pain management for patients undergoing open nephrectomy
Scientific title
Clinical effectiveness of erector spinae catheters in peri-operative analgesia for open nephrectomy patients
Secondary ID [1] 304807 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
nephrectomy 322870 0
peri-operative analgesia 322871 0
pain management 323053 0
Condition category
Condition code
Anaesthesiology 320450 320450 0 0
Pain management
Surgery 320627 320627 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Our proposed randomised controlled study aims to determine if there is an analgesic benefit of erector spinae plane (ESP) catheter block up to 24 hours in patients undergoing open nephrectomy. Specifically:
- procedures and drugs administered: intermittent boluses via Catheter of ropivacaine 0.2%, 30ml bolus every 4 hours
Both arms will also be started on an intravenous patient controlled analgesia
- who will deliver the intervention: anaesthetists
- when the catheter will be placed relative to the nephrectomy procedure: following induction of general anaesthesia and at the beginning of surgery
Intervention code [1] 321177 0
Treatment: Devices
Comparator / control treatment
Control group (Sham ESC group) receiving a sham erector spinae catheter. Specifically:
- what this involves for participants:. a catheter is inserted without administration of anaesthetic, however patients will receive standard patient-controlled analgesia
- when the sham procedure will occur relative to the nephrectomy procedure: sham procedure done after induction as well at the start of the operation
Control group
Placebo

Outcomes
Primary outcome [1] 328283 0
Patient controlled analgesia usage – using patient medical records, PCA usage will be measured by total 24-hour consumption of selected opioid. The selected opioid will be converted to the standard IV morphine equivalent using the ANZCA opioid dose equivalence table.
Timepoint [1] 328283 0
24 hours post-catheter insertion
Secondary outcome [1] 398358 0
Total intraoperative opioid consumption from patient medical records
Timepoint [1] 398358 0
24 hours post-catheter insertion
Secondary outcome [2] 398359 0
Total 72-hour opioid consumption from patient medical records
Timepoint [2] 398359 0
72 hours post-catheter insertion
Secondary outcome [3] 398360 0
Pain score – Brief Pain Inventory (BPI) will be used to record pain scores at post-operative day 1 and day 3
Timepoint [3] 398360 0
Day 1 and day 3 post-catheter insertion

Eligibility
Key inclusion criteria
• Males and females aged 18- 70 years old with an American society of anaesthesiologist (ASA) physical status score of I to III
• Opioid naive
• Patients undergoing open nephrectomy
• Willing to provide informed consent and to participate and comply with the study requirements
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients without prior consent or refusal to participate in the trial
• Pregnancy
• Unstable cardiac disease
• Patients with chronic pain
• Patients with coagulation abnormalities
• Allergy to local anaesthetics
• Skin lesions/infections at site of needle insertion
• Systemic infections
• Patients weight less than 50kg

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)
A sealed envelope system will be used for randomisation. Randomly generated treatment allocations (intervention [ESCP block group] or control [ESC group]) within sealed opaque envelopes will be provided to the research team. Once a patient has consented to enter the trial, an envelope will be opened, and the patient will then be allocated to that treatment regimen.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Members of the research team inserting the catheter will not be blinded to the treatment allocation. This is to allow them to prepare the appropriate analgesia. However, outcome assessors (those who are responsible for post-operative care, administering the BPI, and measuring PCA usage) and investigators analysing the results will be blinded to the allocation groups to limit potential bias.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size calculation was based on a previous RCT comparing opioid use in open nephrectomies for patients receiving a paravertebral block vs general anaesthesia only for open nephrectomies. In this 2 arm study with 17 patients in each arm, the mean and standard deviation for fentanyl consumption in 24 hours for patients receiving general anaesthesia only was 1122 micrograms and 267 micrograms respectively. Using these numbers and determining that a 20% reduction in mean opioid consumption as being clinically significant, taking into account loss to follow-up and unanticipated events a sample of 25 in each arm is required (alpha value of 0.05 and power of 80%).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2021
Actual
Date of last participant enrolment
Anticipated
30/09/2022
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19989 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 34697 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 309176 0
Hospital
Name [1] 309176 0
Royal Prince Alfred Hospital Sydney (in kind)
Country [1] 309176 0
Australia
Primary sponsor type
Hospital
Name
Anaesthetic Department RPA Hospital
Address
Anaesthetic Department, RPA Hospital. 50 Missenden Rd. Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 310135 0
None
Name [1] 310135 0
N/A
Address [1] 310135 0
N/A
Country [1] 310135 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309036 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 309036 0
Research Ethics and Governance Office (REGO)
Royal Prince Alfred Hospital
Missenden Road. Camperdown NSW 2050
Ethics committee country [1] 309036 0
Australia
Date submitted for ethics approval [1] 309036 0
Approval date [1] 309036 0
01/07/2021
Ethics approval number [1] 309036 0
X21-0028 & 2020/ETH03029

Summary
Brief summary
This trial aims to determine the clinical effectiveness of erector spinae catheters in pain management for patients undergoing open nephrectomy.

Participants will be randomised to two arms:
• Intervention (ESP block group):
In the ESP (Erector spinae plane) block group, an ultrasound guided ESP block will be performed in the operating theatre while the patient is under general anesthesia followed by the insertion of an erector spinae catheter (ESC).
The ESP block group will receive a bolus of 30mL of ropivacaine 0.2% every 4 hours for 24 hours.
Our proposed randomised controlled study aims to determine if there is an analgesic benefit of ESP catheter block up to 24 hours in patients undergoing open nephrectomy.
Specifically:
- procedures and drugs administered: intermittent boluses via Catheter of ropivacaine 0.2%, 30ml bolus every 4 hours
Both arms will also be started on an intravenous patient controlled analgesia
- who will deliver the intervention: anaesthetists
- when the catheter will be placed relative to the nephrectomy procedure: following induction of general anaesthesia. At the beginning of surgery
• Control group (Sham ESC group):
In the control group, a sham ESC will be used and taped onto the skin on the back. Patients in this group will have their sham catheter connected to a pump to replicate an ESC. Specifically:
- what this involves for participants:. a catheter is inserted without administration of anaesthetic, however patients will receive standard patient-controlled analgesia
- when the sham procedure will occur relative to the nephrectomy procedure: sham procedure done after induction as well at the start of the operation
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112734 0
Dr Michael Tran
Address 112734 0
Anaesthetic Department
RPA Hospital
Missenden Road, Camperdown NSW 2050
Country 112734 0
Australia
Phone 112734 0
+61401095605
Fax 112734 0
Email 112734 0
[email protected]
Contact person for public queries
Name 112735 0
Dr Michael Tran
Address 112735 0
Anaesthetic Department
RPA Hospital
Missenden Road, Camperdown NSW 2050
Country 112735 0
Australia
Phone 112735 0
+61401095605
Fax 112735 0
Email 112735 0
[email protected]
Contact person for scientific queries
Name 112736 0
Dr Michael Tran
Address 112736 0
Anaesthetic Department
RPA Hospital
Missenden Road, Camperdown NSW 2050
Country 112736 0
Australia
Phone 112736 0
+61401095605
Fax 112736 0
Email 112736 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


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.