Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000113156
Ethics application status
Approved
Date submitted
9/12/2018
Date registered
24/01/2019
Date last updated
26/02/2021
Date data sharing statement initially provided
24/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Erector spinae plane block (ESPB) vs wound infiltration for colonic surgery
Scientific title
Comparison of Ultrasound guided Erector spinae plane block (ESPB) block to wound infiltration (WI) for postoperative analgesia in laparoscopic colonic surgery- Prospective randomized study.
Secondary ID [1] 296408 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
surgical wound pain relief 310164 0
Colorectal surgery 310762 0
Condition category
Condition code
Anaesthesiology 308917 308917 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
: Erector spinae plane (ESP) block Technique: It is single shot technique performed by anaesthetist ( one of the investigators) at the end of the surgical procedure in theatre. An in plane approach in the lateral position will be attempted under the ultrasound guidance. Using a 6- to 15-MHz high-frequency linear probe, Erector spinae (ES) muscles will be visualized at T8 transverse process 22g needle will be used to locate ES, after saline test dose 3mg/kg of ropivacaine (0.5%, 20 mL per side) will be administered. This ESP block is monitored in recovery room and assessed how effective in providing post operative pain relief in colorectal surgery.

Intervention code [1] 312743 0
Prevention
Comparator / control treatment
Wound infiltration involves the surgeons placing local anaesthetics (LA) Ropivacaine 0.5% 20ml on each side ( maximum 3mg/kg up to 200mg) inside the muscle layers of the abdomen, near the wound and key holes under direct vision.
Control group
Active

Outcomes
Primary outcome [1] 307881 0
The primary aim of this study is to assess the pain Scores at rest and cough in recovery and on day one are assessed by 10-point verbal numerical rating scale (VNRS)
Timepoint [1] 307881 0
post anaesthesia care unit and at 24 hours are assessed by 10-point VRNS
Secondary outcome [1] 353213 0
In the first stage of the study the first10 patients in each group will be analysed for ropivacaine blood levels. We would like to report/publish the observations of ropoivacaine levels as an ancillary outcome of this randomised trial.
Timepoint [1] 353213 0
Serum levels baseline 5 min before procedure, post surgery, post regional block, on admission in recovery 10 min, post 60 minutes, post 180 minutes.
Secondary outcome [2] 353214 0
discharge time recorded from the hospital records.
Timepoint [2] 353214 0
Post Operatively discharge
Secondary outcome [3] 353215 0
adverse effects like peri oral numbness or seizures are obtained from the summary summary discharge time recorded from the hospital records
Timepoint [3] 353215 0
24 hours post operatively
Secondary outcome [4] 353216 0
Cost of medical personnel time involved and consumables. This is done by calculating difference between resource use and costs from hospital medical records and business manager.
Timepoint [4] 353216 0
End of the trial.
Secondary outcome [5] 368795 0
post operative opioid use in 24 hrs
outcome will be assessed by hospital electronic records
Timepoint [5] 368795 0
end of 24 hrs on the first post operative day

Eligibility
Key inclusion criteria
ASA 1-3 for laparoscopic colonic surgery under general anaesthesia between the age of 18-85 yrs.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to cooperate, allergy to any drug used in the study, preoperative daily use of opioids, pregnancy or conversion to open surgery. Patients receiving epidural, or on regular opioid medication or any other medication for chronic pain management

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization will be done using a computer software. The proceduralist will receive a closed opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer Software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The data will be analysed using the following methods: differences between the
continuous variables by the “t”-test; categorical variables by Fisher's exact test. The pain scores between groups will be analysed by rank non-parametric methods (Man Whitney U test).
Statistical analysis: Continuous measures will be presented as means with standard deviations and medians with interquartile range. Categorical measures will be presented as counts and percentages. Group comparisons on baseline characteristics will be assessed using Student’s T-test or Pearson’s Chisquare statistic as required. For outcome measures, changes over time will be assessed using linear mixed effects models with patient treated as a random factor. All tests will be two-tailed and assessed at the 5% alpha-level.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/01/2019
Actual
19/03/2019
Date of last participant enrolment
Anticipated
Actual
7/09/2020
Date of last data collection
Anticipated
31/07/2020
Actual
11/09/2020
Sample size
Target
72
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 12255 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [2] 12256 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 24441 0
5011 - Woodville
Recruitment postcode(s) [2] 24442 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 301017 0
Hospital
Name [1] 301017 0
Department of Anaesthesia The Queen Elizabeth hospital
Country [1] 301017 0
Australia
Primary sponsor type
Hospital
Name
The Queen Elizabeth Hospital
Address
Department of Anaesthesia, The Queen Elizabeth Hospital
28 Woodville Road Woodville south. SA 5011
Country
Australia
Secondary sponsor category [1] 300604 0
Hospital
Name [1] 300604 0
Royal Adelaide Hospital
Address [1] 300604 0
Port Road
Department of Anaesthesia The Royal Adelaide Hospital
Adelaide 5000 SA
Country [1] 300604 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301772 0
Central Adelaide Local Health Network Human Research Ethics Committee - HREC
Ethics committee address [1] 301772 0
Ethics committee country [1] 301772 0
Australia
Date submitted for ethics approval [1] 301772 0
21/06/2018
Approval date [1] 301772 0
16/10/2018
Ethics approval number [1] 301772 0
HREC reference: HREC/18/CALHN/456

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

Contacts
Principal investigator
Name 88050 0
A/Prof Vasanth RaoKadam
Address 88050 0
The Queen Elizabeth Hospital, Department of Anaesthesia, 28 Woodville road, Woodville south.SA.5011
Country 88050 0
Australia
Phone 88050 0
+61 8 82226480
Fax 88050 0
Email 88050 0
[email protected]
Contact person for public queries
Name 88051 0
Vasanth Raokadam
Address 88051 0
The Queen Elizabeth Hospital Department of Anaesthesia, 28 Woodville road, Woodville south.SA.5011
Country 88051 0
Australia
Phone 88051 0
+61 882226480
Fax 88051 0
Email 88051 0
[email protected]
Contact person for scientific queries
Name 88052 0
Vasanth Raokadam
Address 88052 0
The Queen Elizabeth Hospital Department of Anaesthesia, 28 Woodville road, Woodville south.SA.5011
Country 88052 0
Australia
Phone 88052 0
+61 882226000
Fax 88052 0
+61 882227065
Email 88052 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
Individual participation data of this trial not for sharing


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
669Ethical approval    Ethics approval email 376248-(Uploaded-09-12-2018-16-57-43)-Study-related document.docx



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA comparison of ultrasound guided bilateral single injection shot Erector Spinae Plane blocks versus wound infiltration for post-operative analgesia in laparoscopic assisted colonic surgery- a prospective randomised study.2021https://dx.doi.org/10.1186/s12871-021-01474-8
N.B. These documents automatically identified may not have been verified by the study sponsor.