Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001123538
Ethics application status
Approved
Date submitted
6/10/2015
Date registered
26/10/2015
Date last updated
4/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The analgesic effectiveness of an Ilioinguinal-Transversus Abdominis Plane (iTAP) injection technique nerve block in addition to opioid plus NSAID analgesia for elective Caesarean Sections.
Scientific title
The efficacy of an Ilioinguinal-Transversus Abdominis Plane (iTAP) injection technique nerve block in addition to opioid plus NSAID post-operative analgesia for elective Caesarean Sections under spinal anaesthetic block with intrathecal morphine in reducing the opioid usage in the first 24 hours post-operatively compared to opioid plus NSAID post-operative analgesia alone.
Secondary ID [1] 287609 0
Nil known
Universal Trial Number (UTN)
U1111-1175-2460
Trial acronym
iTAPIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain following caesarean section 296410 0
Condition category
Condition code
Anaesthesiology 296677 296677 0 0
Anaesthetics
Reproductive Health and Childbirth 296678 296678 0 0
Childbirth and postnatal care
Anaesthesiology 296748 296748 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single shot bilateral iTAP nerve block using total of 60mls of 0.33% (i.e. 200mg) ropivacaine post-caesarean section in the Post-Operative Recovery Unit (PARU) before spinal anaesthetic has worn off

iTAP - TECHNIQUE
Single shot nerve block which combines a traditional TAP block and a traditional ilioinguinal-iliohypogastric nerve block.

Landmarks: 2cm medial and superior to the ASIS. Sonoplex short bevel needle inserted perpendicular to skin until "1st pop" is felt and 10mls ropivacaine injected. Needle advanced until "2nd pop" felt and 20mls of ropivacaine is injected. Nerve block repeated on the other side.
Intervention code [1] 293003 0
Treatment: Drugs
Comparator / control treatment
Control group will receive a simulated block. This includes skin preparation, needle sensation simulation using a blunt needle without skin puncture and identical dressings to the intervention group. Patients will be blinded through the use of a screen during block performance.
Control group
Placebo

Outcomes
Primary outcome [1] 296283 0
Total PCA opioid (fentanyl) usage by review of medical records (PCA chart)
Timepoint [1] 296283 0
0, 4, 8, 16 and 24 hours post iTAP/simulated nerve block
Secondary outcome [1] 318052 0
Pain assessed using a VAS (visual analogue scale) (mm) on movement and at rest.
Timepoint [1] 318052 0
0, 4, 8, 16 and 24 hours post iTAP/simulated nerve block
Secondary outcome [2] 318053 0
Opioid adverse effects
- Sedation score as reviews in medical records from nursing / APS observation
- Nausea and/or vomiting requiring treatment as expressed by participant / medical records
- Pruritus requiring treatment as reviewed in medical records from nursing / APS observation
Timepoint [2] 318053 0
0, 4, 8, 16 and 24 hours post iTAP/simulated nerve block
Secondary outcome [3] 318054 0
Additional analgesia required by review of medical records
Timepoint [3] 318054 0
24 hours post iTAP/simulated nerve block
Secondary outcome [4] 318055 0
iTAP nerve block complications. Assessed by review of medical records and as expressed by participant. Potential complications include bleeding, infection, peritoneal puncture, LA toxicity, femoral nerve palsy and LA allergy
Timepoint [4] 318055 0
24 hours post iTAP/simulated nerve block
Secondary outcome [5] 318056 0
Score of maternal satisfaction with post-operative analgesia (excellent, satisfactory, neutral, unsatisfactory, no benefit) as assessed by brief questionnaire designed for this study given to participant 24 hours post nerve block
Timepoint [5] 318056 0
24 hours post iTAP/simulated nerve block
Secondary outcome [6] 320228 0
Comparison of potentially confounding variables as obtained from participant and medical records.
Information includes:
- Age (years)
- Gravidity and Parity
- ASA (1-4)
- Weight at time of booking (kg)
- Height at time of booking (cm)
- BMI at time of booking
- Previous LSCS (yes or no)
- Previous abdominal surgeries (yes or no)
- Time of spinal
- Duration of surgery (min)
- Regular paracetamol received post-operatively (yes or no)
- Regular NSAID received post-operatively (yes or no)
Timepoint [6] 320228 0
No specific time point. Information will be collected during participation in trial.

Eligibility
Key inclusion criteria
Competent to sign consent
Elective Caesarean Section
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Emergency surgery
Age < 18 years
< 65kg
Inability to consent, lack of written consent or speak English fluently
Contraindication to spinal anaesthetic or block
Allergy to local anaesthetics or morphine
Pre-operative chronic opioid use or chronic pain syndrome
Progressive neurological disease
Patients in EREC (enhanced recovery after elective Caesarean Section) protocol

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)
Sealed opaque envelopes opened by block proceduralist just prior to performance of block
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
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
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
We aim to recruit 100 participants in total (50 participants per group). This is consistent with a similar previous study that calculated a sample size of 90 participants in total (not accounting for dropouts) for total opioid usage at 24 hours based on a minimum detectable difference between means of 20 mg, alpha=0.05, power=0.9, and standard deviation of 25 / 30 mg with a two sample, two-tailed Student’s t-test. Our study includes repeated measures of total opioid usage at 0, 4, 8, 16, and 24 hours and will likely have greater statistical power, but no pilot data is available for formal power analysis.

Statisitcal analyses will be performed using Stata/IC 14.0 (StataCorp, Texas, USA) using an intention-to-treat approach. The statistician will be blinded to the coding of analgesia type in the data. Continuous variables (total opioid usage, visual analogue scale) will be analysed with a two-way repeated measures ANOVA with a between-subjects factor of analgesia type and a within-subjects factor of time, and assumptions checked using residuals diagnostics. Binary outcomes (presence of nausea/vomiting, pruritus requiring treatment, additional analgesia at 24 hours, iTAP block complications at 24 hours) will be analysed with Fisher’s Exact Test. Ordinal variables (sedation score, maternal satisfaction) will be analysed using ordinal logistic regression with one predictor variable, analgesia type. All analyses will use alpha=0.05 with no family-wise corrections.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2016
Actual
4/02/2016
Date of last participant enrolment
Anticipated
1/06/2016
Actual
29/06/2016
Date of last data collection
Anticipated
Actual
30/06/2016
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 4432 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 10637 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 292174 0
Self funded/Unfunded
Name [1] 292174 0
Dr Jessica Staker
Country [1] 292174 0
Australia
Primary sponsor type
Individual
Name
Dr Jessica Staker
Address
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale
SA 5112
Country
Australia
Secondary sponsor category [1] 290846 0
Individual
Name [1] 290846 0
Dr Thien LeCong
Address [1] 290846 0
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale
Sa 5112
Country [1] 290846 0
Australia
Secondary sponsor category [2] 290847 0
Individual
Name [2] 290847 0
Dr Richard Church
Address [2] 290847 0
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale
SA 5112
Country [2] 290847 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293647 0
The Queen Elizabeth Hospital/Lyell McEwin Hospital/Modbury Hospital Human Research Ethics Committee
Ethics committee address [1] 293647 0
Basil Hetzel Institute
28 Woodville Road
Woodville South
SA 5011
Ethics committee country [1] 293647 0
Australia
Date submitted for ethics approval [1] 293647 0
12/09/2015
Approval date [1] 293647 0
02/12/2015
Ethics approval number [1] 293647 0
HREC/15/TQEH/196
Ethics committee name [2] 294261 0
Site specific ethics - Northern Adelaide Local Health Network
Ethics committee address [2] 294261 0
Research governance office
Level 2, clinical trials unit
Lyell McEwin hospital
Haydown road
Elizabeth vale
SA
5112
Ethics committee country [2] 294261 0
Australia
Date submitted for ethics approval [2] 294261 0
30/11/2015
Approval date [2] 294261 0
24/12/2015
Ethics approval number [2] 294261 0
SSA/15/NALHN/102

Summary
Brief summary
PURPOSE
One of the methods of providing pain relief after a Caesarean Section involves the injection of local anaesthetic into the muscle layers to surround the nerves that supply pain sensation to the lower abdomen. These blocks are called Ilioinguinal / Iliohypogastric nerve blocks and Transversus Abdominis Plane (TAP) blocks and have been used for a range of surgeries. This helps to reduce pain over the surgical wound where the Caesarean Section is performed.

The purpose of this study is to determine if combining these blocks in addition to opioid and anti-inflammatory pain management will improve pain relief in the first 24 hours for women who have an elective Caesarean Section. This block will be performed at the end of the Caesarean section before the spinal anaesthetic has worn off.

HYPOTHESIS
Our primary aim is to determine whether administering the modified Ilioinguinal-Transversus Abdominis Plane (iTAP) nerve block in addition to opioid plus NSAID analgesia is superior to opioid plus NSAID analgesia alone following caesarean section with a Pfannenstiel incision.

STUDY DESIGN AND INTERVENTION
Approximately 100 volunteers will participate in this study and the study will be conducted at the Lyell McEwin Hospital. You will be enrolled in this study on the day of your Caesarean Section and randomly allocated to one of two groups. One group will receive pain medication with the iTAP block in the Post Anaesthetic Recovery Unit (PARU) as well as opioid medication (Fentanyl) through a Patient Controlled Analgesia (PCA) device. The second group will receive pain medication with the PCA but will receive a placebo block. A placebo is a medication with no active ingredients or a procedure without any medical benefit. It will feel like the real thing but it is not. Your participation in the study will continue until 24 hours after the iTAP block / placebo block.

OUTCOMES
We will be measuring total pain medication usage (opioids) and pain levels (VAS) over a 24 hour period. We will also measure adverse side effects of pain medication and the block, as well as the satisfaction of our participants. Hopefully there will be less pain and pain medication usage in our interventional group.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 60814 0
Dr Jessica Staker
Address 60814 0
Lyell McEwin Hospital
Haydown road
Elizabeth Vale
SA 5112
Country 60814 0
Australia
Phone 60814 0
+618 81829000
Fax 60814 0
Email 60814 0
jjstaker@gmail.com
Contact person for public queries
Name 60815 0
Dr Jessica Staker
Address 60815 0
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale
SA 5112
Country 60815 0
Australia
Phone 60815 0
+6181829000
Fax 60815 0
Email 60815 0
jjstaker@gmail.com
Contact person for scientific queries
Name 60816 0
Dr Jessica Staker
Address 60816 0
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale
SA 5112
Country 60816 0
Australia
Phone 60816 0
+618 81829000
Fax 60816 0
Email 60816 0
jjstaker@gmail.com

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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