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Trial registered on ANZCTR


Registration number
ACTRN12613000392763
Ethics application status
Approved
Date submitted
12/03/2013
Date registered
10/04/2013
Date last updated
29/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing the use of a needle guidance device with free-hand
technique in performing ultrasound-guided transversus abdominis plane (TAP) blocks: a
prospective randomized trial.
Scientific title
In adult patients undergoing bilateral ultrasound-guided transversus abdominis plane (TAP) blocks, does the use of a needle guidance device compared to a free-hand technique when performing the TAP block increase needle tip visibility and reduce procedural time?
Secondary ID [1] 282035 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major abdominal surgery requiring transversus abdominis plane block. 288495 0
Condition category
Condition code
Anaesthesiology 288843 288843 0 0
Anaesthetics
Anaesthesiology 289106 289106 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a crossover study, where participants are randomly assigned to two groups. Group 1 participants will receive the transversus abdominis plane (TAP) block via the needle guided technique and then followed by free hand technique whilst Group 2 participants will receive the TAP block via free hand technique and then followed by needle guided technique.

The intervention is the use of an ultrasound needle guide (Infiniti, CIVCO Medical Solutions, Kalona, Iowa, USA) when performing an ultrasound-guided TAP block.

The ultrasound needle guide consists of two parts, a reusable bracket that is placed beneath the probe cover, and disposable needle guides that attach to the brackets. The needle is passed through the attached needle guide, which holds the needle in the plane of the ultrasound probe.

The TAP block will be performed with a 21-gauge 100 mm Stimuplex needle and 200 mg of ropivacaine for patients more than or equal to 70 kg (20 ml of 0.5% ropivacaine each side) or 150 mg of ropivacaine for patients less than 70 kg (20 ml of 0.375% ropivacaine each side). The ultrasound probe will be placed in a transverse plane to the lateral abdominal wall in the midaxillary line, between the lower costal margin and iliac crest. The needle will then be introduced in-plane of the ultrasound probe and advanced until the tip reaches the plane between the internal oblique and transversus abdominis muscles. At this point 20 ml of ropivacaine solution will be injected in 5 ml aliquots after negative aspiration. The transversus abdominis plane will be visualized expanding with the injection. The intervention will be completed within 5-10 minutes. The duration of the wash-out period is 5 minutes.
Intervention code [1] 286640 0
Treatment: Devices
Comparator / control treatment
A free-hand technique when performing an ultrasound-guided TAP block.

With a free-hand technique, the needle is separate to the ultrasound probe. When advancing the needle the ultrasound probe is shifted to locate the needle tip and adjustments are made to the position of the needle by the user.

The TAP block will be performed with a 21-gauge 100 mm Stimuplex needle and 200 mg of ropivacaine for patients more than or equal to 70 kg (20 ml of 0.5% ropivacaine each side) or 150 mg of ropivacaine for patients less than 70 kg (20 ml of 0.375% ropivacaine each side). The ultrasound probe will be placed in a transverse plane to the lateral abdominal wall in the midaxillary line, between the lower costal margin and iliac crest. The needle will then be introduced in-plane of the ultrasound probe and advanced until the tip reaches the plane between the internal oblique and transversus abdominis muscles. At this point 20 ml of ropivacaine solution (as described above) will be injected in 5 ml aliquots after negative aspiration. The transversus abdominis plane will be visualized expanding with the injection. The intervention will be completed within 5-10 minutes. The duration of the wash-out period is 5 minutes.
Control group
Active

Outcomes
Primary outcome [1] 288971 0
Proportion of needle visibility - the ratio of time that the needle was completely visualised by ultrasound throughout the procedure will be recorded. The ratio of this time to the overall procedural time (see below) will be calculated.
Timepoint [1] 288971 0
Ultrasounds are recorded at time of procedure.
Primary outcome [2] 288972 0
Total procedural time - the time taken from needle insertion to successful injection of local anaesthetic in the transversus abdominis plane.
Timepoint [2] 288972 0
At time of procedure.
Secondary outcome [1] 301472 0
Proceduralist’s satisfaction score - proceduralists will be asked to rank their satisfaction with both techniques on a scale from 0 (lowest score: completely dissatisfied) to 10 (best score: completely satisfied).
Timepoint [1] 301472 0
At time of procedure.
Secondary outcome [2] 301473 0
Dermatomal blockade - sensory assessment (using pinprick and ice) will be conducted by a blinded observer in the post-anaesthesia care unit.
Timepoint [2] 301473 0
Baseline, and at 30 minutes after procedure.

Eligibility
Key inclusion criteria
Patients must be aged 18 years or over, must be undergoing open abdominal surgery, and are scheduled for bilateral, single shot, ultrasound guided in-plane TAP blocks administered during general anaesthesia at the completion of surgery.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients who are unable (due to an intellectual disability, cognitive deficit or language barrier) or unwilling to consent, who have a contraindication to undergoing TAP blocks (coagulopathy, local skin infection, allergy to ropivacaine or planned administration of large volume local anaesthetic by another route [e.g. epidural]) or who will not be available for assessment postoperatively (i.e. ventilated patients) will be excluded.

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)
After written informed consent is obtained, patients will be assigned using computer-generated randomization to one of two groups - group 1 – needle guided technique followed by free hand technique, or group 2 – free hand technique followed by needle guided technique. Randomisation results will be concealed in opaque sequentially numbered envelopes until after consent has been obtained.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomization.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
Continuous data will be tested for normality. Values will be expressed as mean (+/- standard deviation), median (range), and percentages as appropriate. Comparisons between the groups will be performed by paired t-test for normally distributed data and Wilcoxon’s signed rank test for non-parametric or skewed data. A P value < 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 701 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 6443 0
3050 - Royal Melbourne Hospital

Funding & Sponsors
Funding source category [1] 286820 0
Hospital
Name [1] 286820 0
Department of Anaesthesia Research Cost Centre
Address [1] 286820 0
3 North
The Royal Melbourne Hospital
Grattan Street
Parkville
VIC 3050
Country [1] 286820 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
3 North
The Royal Melbourne Hospital
Grattan Street
Parkville
VIC 3050
Country
Australia
Secondary sponsor category [1] 285608 0
None
Name [1] 285608 0
Address [1] 285608 0
Country [1] 285608 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288886 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 288886 0
The Royal Melbourne Hospital
Grattan Street
Parkville
VIC 3050
Ethics committee country [1] 288886 0
Australia
Date submitted for ethics approval [1] 288886 0
26/10/2012
Approval date [1] 288886 0
06/03/2013
Ethics approval number [1] 288886 0
2012.243

Summary
Brief summary
This study is designed to determine whether the use of the CIVCO (Registered Trademark) ultrasound needle guide (Infiniti, CIVCO Medical Solutions, Kalona, Iowa, USA) will improve visualisation of the needle tip during ultrasound-guided TAP blocks when compared with the “free hand” technique for patients undergoing major abdominal surgery. Furthermore, we aim to study whether it will shorten the procedural time, improve operator satisfaction or lead to increased dermatomal blockade.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38186 0
Dr Irene Ng
Address 38186 0
3 North
Department of Anaesthesia and Pain Management
The Royal Melbourne Hospital
Grattan Street
Parkville
VIC 3050
Country 38186 0
Australia
Phone 38186 0
+61 3 9342 7540
Fax 38186 0
+61 3 9342 8623
Email 38186 0
irene.ng@mh.org.au
Contact person for public queries
Name 38187 0
Dr Irene Ng
Address 38187 0
3 North
Department of Anaesthesia and Pain Management
The Royal Melbourne Hospital
Grattan Street
Parkville
VIC 3050
Country 38187 0
Australia
Phone 38187 0
+61 3 9342 7540
Fax 38187 0
+61 3 9342 8623
Email 38187 0
irene.ng@mh.org.au
Contact person for scientific queries
Name 38188 0
Dr Irene Ng
Address 38188 0
3 North
Department of Anaesthesia and Pain Management
The Royal Melbourne Hospital
Grattan Street
Parkville
VIC 3050
Country 38188 0
Australia
Phone 38188 0
+61 3 9342 7540
Fax 38188 0
+61 3 9342 8623
Email 38188 0
irene.ng@mh.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary