Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001262493p
Ethics application status
Submitted, not yet approved
Date submitted
23/08/2016
Date registered
8/09/2016
Date last updated
8/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Analgesia outcome of surgically guided regional anaesthesia technique versus wound infiltration of 80 patients undergoing elective Lower Uterine Caesarean Section (LUCS) under Spinal anaesthesia
Scientific title
Analgesia outcome of surgically guided direct vision Transversus Abdominis Plane TAP block v standard surgical infiltration of Pfannenstiel wound during elective LUCS under Neuraxial Blockade ( NAB) anesthesia - a randomised controlled trial involving 80 participants
Secondary ID [1] 289951 0
Nil
Universal Trial Number (UTN)
Trial acronym
WIVSGTAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Woman undergoing elective Lower Uterine caesarean Section (LUCS) delivery via the Pfannenstiel incision, under Neuraxial Blockade (NAB) 299934 0
post operative analgesia outcome 299935 0
Condition category
Condition code
Anaesthesiology 299834 299834 0 0
Pain management
Reproductive Health and Childbirth 300019 300019 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2.5mg/kg Ropivacaine (up to maximum of 200mg) based on booking weight, diluted to 40ml, then injected under the Transversus Abdominis Plane 20 ml each side
The Ropivacaine will be injected by the surgeon under direct surgical vision
The injection will be administered prior to the final layers of tissue being sutured close
Fidelity will be maintained by providing specific training to 2-3 surgeons and only allowing them to perform the intervention for involvement in the study.
Intervention code [1] 295638 0
Treatment: Drugs
Comparator / control treatment
2.5mg/kg Ropivacaine ( up to maximum of 200mg), based on booking weight, diluted to 40ml infiltrated under the wound.
The intervention will be administered by the surgeon
The intervention will be the last step in the LSCS, prior to applying the wound bandage.
Control group
Active

Outcomes
Primary outcome [1] 299311 0
VAS pain scores
Timepoint [1] 299311 0
Data is collected at 2, 4, 6, 12, 24 and 48 hours post administration of Ropivacaine
Primary outcome [2] 299504 0
Analgesic consumption as assessed by doctors on research team
Timepoint [2] 299504 0
Data is collected at 2, 4, 6, 12, 24 and 48 hours post administration of Ropivicaine
Secondary outcome [1] 326815 0
Patient satisfaction scores are recorded at 24 and 48 hours using a Likert based scale designed for this study
Timepoint [1] 326815 0
Recorded at 24 and 48 hours post administration of Ropivacaine
Secondary outcome [2] 326816 0
PONV scores
Timepoint [2] 326816 0
Data is collected at 2, 4, 6, 12, 24 and 48 hours post administration of Ropivicaine
Secondary outcome [3] 326817 0
Sedation Scores based on the 'Opioid Induced Sedation Scale'
Timepoint [3] 326817 0
Data is collected at 2, 4, 6, 12, 24 & 48 hours post administration of Ropivicaine
Secondary outcome [4] 326818 0
Pruritis Scores assessed on a 10-point scale similar to the VAS scale
Timepoint [4] 326818 0
Data is collected at 2, 4, 6, 12, 24 & 48 hours post administration of Ropivicaine
Secondary outcome [5] 327583 0
Time to first rescue analgesia
Timepoint [5] 327583 0
Patient to request top up analgesia as required.
Time to this first dose of 'rescue' analgesia gathered from medication chart by data collector

Eligibility
Key inclusion criteria
Pregnant awaiting elective Lower Uterine caesarean Section (LUCS) delivery via the Pfannenstiel incision, under Neuraxial Blockade (NAB)
Minimum age
18 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Non- elective Lower Uterine caesarean Section (LUCS) patients as obtaining informed consent and accurate follow up and would be problematic.
Those with a ASA status of 3 or greater have been excluded as they are likely to require a more flexible and a less protocolised anaesthetic and analgesic management for their treatment regime.

Opiate tolerance – defined as those patients already on opiate medication or those with a history of opiate addiction

Perioperative medications that differ or are expected to differ from the study protocol
Those who receive a regional anaesthetic at the discretion of their treating anaesthetist that differs from the study protocol
or obstetrician who considers or requests a uterotonic agent that differs from the study protocol
postoperative analgesia regimen
unable to tolerate NSAIDS, Paracetamol or endone/ Targin

Failure of the NAB

Bleeding diathesis ( e.g. vWF ): at risk of haematoma at injection or operative site

Allergy to study medications specifically: amide Local anaesthetic agents

Inability to independently understand the nature of the consent or not be able to respond appropriately and independently to the post operative data collection.

Peri-operative complications
Post Partum Haemorrhage/Uterine atony requiring further medical or surgical intervention: postoperative drain(s) required

The participant withdraws or declines to participate in this study

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)
Shuffled envelopes containing a plain white card with either of the intervention groups of equal number in each group are shuffled.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
As the participants are selected the envelopes are drawn on a sequential basis and place inside the participants chart.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Continuous variables for example time to first rescue analgesia will be compared by applying the student’s t test.
Discrete variable such as VAS scores will be compared by applying the Mann–
Whitney U test.
The number of participants required was calculated on 2 comparative means with the aim of achieving a 10% difference with a 95% C.I. Based on these parameters, calculations made on samplesize.com confirmed that a study population of at least 80 patients is required.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2016
Actual
Date of last participant enrolment
Anticipated
31/08/2017
Actual
Date of last data collection
Anticipated
30/09/2017
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 6531 0
Redland Hospital - Cleveland
Recruitment postcode(s) [1] 14110 0
4163 - Cleveland
Recruitment postcode(s) [2] 14111 0
4165 - Redland Bay

Funding & Sponsors
Funding source category [1] 294369 0
Hospital
Name [1] 294369 0
Redland Hospital
Country [1] 294369 0
Australia
Primary sponsor type
Hospital
Name
Redland Hospital
Address
Redland Hospital
Weippin St, Cleveland QLD 4163
Country
Australia
Secondary sponsor category [1] 293212 0
None
Name [1] 293212 0
Address [1] 293212 0
Country [1] 293212 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 295787 0
Metro South Research Governance
Ethics committee address [1] 295787 0
Princess Alexandra Hospital, Centres for Health Research, Level 7, Translational Research Institute, 37 Kent Street, WOOLLOONGABBA QLD 4102
Ethics committee country [1] 295787 0
Australia
Date submitted for ethics approval [1] 295787 0
18/08/2016
Approval date [1] 295787 0
Ethics approval number [1] 295787 0

Summary
Brief summary
This study is comparing the analgesia outcome of surgically guided direct vision Transverses Abdominis Plain ( TAP) block versus standard surgical infiltration of Pfannenstiel wound during elective Lower Uterine caesarean Section (LUCS) delivery via the Pfannenstiel incision, under Neuraxial Blockade (NAB) anaesthesia at 2, 6, 12, 24, and 48 hours postoperatively. The Null hypothesis is that there is no difference in analgesic outcome between these two techniques. The study will also seek to compare post operative nausea and vomiting PONV rates, sedation, pruritis and patient satisfaction score between these two groups. It will also look at ease of instillation of the Local anaesthetic in the correct plane and whether this correlates to analgesia outcome.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1055 1055 0 0
/AnzctrAttachments/371130-WIVSGTAP protocol _V6_ Analgesia outcome of surgically guided direct vision TAP v standard surgical infiltration of Pfannenstiel wound during elective LUCS_letter head and page.doc (Protocol)

Contacts
Principal investigator
Name 67578 0
Dr Paul Sherwin
Address 67578 0
Metro South Health, Redland Hospital
Weippin Street, Cleveland Queensland 4163
Country 67578 0
Australia
Phone 67578 0
+61 734883111
Fax 67578 0
+61 7 3488 3029
Email 67578 0
[email protected]
Contact person for public queries
Name 67579 0
Wendy Dutton
Address 67579 0
Metro South Health, Redland Hospital
Weippin Street, Cleveland Queensland 4163
Country 67579 0
Australia
Phone 67579 0
+61 7 3488 3111
Fax 67579 0
+61 7 3488 3029
Email 67579 0
[email protected]
Contact person for scientific queries
Name 67580 0
Paul Sherwin
Address 67580 0
Metro South Health, Redland Hospital
Weippin Street, Cleveland Queensland 4163
Country 67580 0
Australia
Phone 67580 0
+61 7 3488 3111
Fax 67580 0
Email 67580 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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