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Trial registered on ANZCTR


Trial ID
ACTRN12617000589381
Ethics application status
Approved
Date submitted
23/03/2017
Date registered
26/04/2017
Date last updated
17/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Surgical transversus abdominis plane (TAP) blocks for post-operative pain relief following lower segment caesarean section (LSCS) under spinal anaesthesia.
Scientific title
A blinded randomised controlled trial assessing the efficacy of surgical transversus abdominis plane (TAP) blocks on reducing pain scores and analgesia requirements following lower segment caesarean section (LSCS) under spinal anaesthesia
Secondary ID [1] 291508 0
None
Universal Trial Number (UTN)
U1111-1194-5467
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative pain following lower segment caesarean section 302587 0
Condition category
Condition code
Anaesthesiology 302113 302113 0 0
Pain management
Reproductive Health and Childbirth 302201 302201 0 0
Childbirth and postnatal care
Surgery 302202 302202 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Bilateral surgical transversus abdominis plane block using a total 2mg/kg of ropivicaine in 40mls normal saline. 20mls of the solution to be injected into each side of the lateral abdominal wall by the surgeon once haemostasis has been achieved following delivery of the baby and closure of the uterus. The intervention group will also receive standard oral analgesia post-operatively.
Intervention code [1] 297580 0
Treatment: Drugs
Comparator / control treatment
The control group will receive standard care rather than an invasive saline placebo as this is felt to be more consistent with considerations of patient safety and in keeping with the Helskini Declaration. Both groups will therefore receive standard oral analgesia post-operatively which includes: paracetamol 1g four times a day, ibuprofen 400mg three times a day and slow release oxycodone/naloxone (Targin) 20/10mg twice daily for 48 hours with as required oral oxycodone 10-15mg 3 hourly and intravenous/oral tramadol 50-100mg 6 hourly.
Control group
Active

Outcomes
Primary outcome [1] 301551 0
Dynamic visual analogue scale (VAS) pain score (0-100mm)
Timepoint [1] 301551 0
Six (6) hours post-operatively
Secondary outcome [1] 333006 0
Rest visual analogue scale (VAS) pain score (0-100mm)


Timepoint [1] 333006 0
2, 6, 24 and 48 hours post-operatively
Secondary outcome [2] 333007 0
Cumulative oxycodone IR use
Timepoint [2] 333007 0
2, 6, 24 and 48 hours post-operatively

Secondary outcome [3] 333008 0
Patient satisfaction scores: (10: completely satisfied, 1: completely dissatisfied)

Timepoint [3] 333008 0
24 and 48 hours post-operatively
Secondary outcome [4] 333009 0
Opioid-related adverse effects: sedation
Assessed by the Ramsay Sedation score 1-6
1 Agitated and anxious, 2 orientated and tranquil, 3 asleep but responsive to commands only, 4 asleep but brisk response to loud auditory stimulus, 5 response only to pain, no response to any stimuli.

Timepoint [4] 333009 0
2, 6, 24 and 48 hours post-operatively
Secondary outcome [5] 333010 0
Opioid-related adverse effects: nausea and vomiting
Graded 0-3 where 0 is none, 1 is mild with no treatment required, 2 is moderate and treatment required and helpful and 3 is severe where treatment is required and not helpful.
Timepoint [5] 333010 0
2, 6, 24 and 48 hours post-operatively
Secondary outcome [6] 333410 0
Dynamic visual analogue scale (VAS) pain score (0-100mm)
Timepoint [6] 333410 0
2, 24 and 48 hours post-operatively
Secondary outcome [7] 333411 0
Opioid-related adverse effects: itching
Graded 0-3 where 0 is none, 1 is mild with no treatment required, 2 is moderate and treatment required and helpful and 3 is severe where treatment is required and not helpful.
Timepoint [7] 333411 0
2, 6, 24 and 48 hours post-operatively
Secondary outcome [8] 333412 0
Opioid-related adverse effects: constipation
Graded 0-3 where 0 is none, 1 is mild with no treatment required, 2 is moderate and treatment required and helpful and 3 is severe where treatment is required and not helpful.
Timepoint [8] 333412 0
48 hours post-operatively

Eligibility
Key inclusion criteria
Women at full term (>37 weeks)
Singleton pregnancy
ASA 1 or 2
Booked for elective caesarean section under spinal anaesthesia.
Uncomplicated lower uterine segment caesarean section (eg. no abnormal placentation).
Written informed consent
18 years or older
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
ASA 3 or greater
Weight<60kg or >100kg
Hepatic or renal dysfunction
History of chronic pain requiring more than simple analgesia
Allergy/sensitivity to local anaesthetic or any other protocol medication
Drug or alcohol abuse
Caesarean section under general anaesthesia
Failure of spinal anaesthesia
Emergency caesarean section
Signs or symptoms of labour
Non-English speaking or inability to easily respond appropriately and independently to the post-operative questioning.
Caesarean section anticipated to be greater than 1.5 hours duration.
Complicated caesarean section e.g. requiring hysterectomy
Post-partum haemorrhage requiring further medical or surgical intervention
Localised infection at Pfannenstiel wound
Withdrawal of participant from the 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)
Sealed opaque envelopes will be used to allocate each participant to one of the 2 groups. Envelopes will be opened by the anaesthetic nurse after delivery of the baby and closure of the uterus. The card will be shown to the scrub nurse and surgeon but not verbalised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be achieved using a computer-generated random number table to allocate each participant to one of the 2 groups
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
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
A pilot audit of our Acute Pain Service data revealed the mean (SD) maximum pain score (0-10 mm) in the first 12 hours following caesarean section was 5.39 (2.14). It was considered that a 20% reduction in VAS pain score would be clinically important. Sample size calculation based on a student’s t test with two groups, power =0.8, alpha 0.05, revealed 42 patients required in each group.
We will aim to recruit 50 patients in each group in order to allow for patient dropouts, protocol violations, etc.

Demographic and obstetric data will be displayed as mean and standard deviation, median with interquartile ranges or number and percentage as appropriate.
Outcomes will be assessed on an intention to treat basis.
Categorical variables will be assessed using Chi squared test (or if appropriate Fischer’s Exact test). Continuous variables will be assessed using ANOVA or repeated measures ANOVA where appropriate. Ordinal categorical variables will be assessed using the exact Cochrane Armitage test. The null hypothesis will be rejected if p < 0.05 for each of the variables. All analyses will be performed using Stata/MP 13.1 (Stata Software Inc., Chicago IL).

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] 7699 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 15622 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 295997 0
Hospital
Name [1] 295997 0
The Royal Women's Hospital
Address [1] 295997 0
20 Flemington Road
Parkville
Victoria 3052

Country [1] 295997 0
Australia
Primary sponsor type
Individual
Name
James Griffiths
Address
The Royal Women's Hospital
20 Flemington Road
Parkville
Victoria 3052

Country
Australia
Secondary sponsor category [1] 294883 0
Individual
Name [1] 294883 0
Thomas Callaghan
Address [1] 294883 0
The Royal Women's Hospital
20 Flemington Road
Parkville
Victoria 3052
Country [1] 294883 0
Australia
Secondary sponsor category [2] 294886 0
Individual
Name [2] 294886 0
Thaamharah Mahendrayogam
Address [2] 294886 0
The Royal Women's Hospital
20 Flemington Road
Parkville
Victoria 3052
Country [2] 294886 0
Australia
Other collaborator category [1] 279494 0
Individual
Name [1] 279494 0
Sarah Grant
Address [1] 279494 0
The Royal Women's Hospital
20 Flemington Road
Parkville
Victoria 3052
Country [1] 279494 0
Australia
Other collaborator category [2] 279495 0
Individual
Name [2] 279495 0
Tom Cade
Address [2] 279495 0
The Royal Women's Hospital
20 Flemington Road
Parkville
Victoria 3052
Country [2] 279495 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297258 0
Human Research and Ethics Committee
Ethics committee address [1] 297258 0
The Royal Women's Hospital
20 Flemington Road
Parkville
Victoria 3052
Ethics committee country [1] 297258 0
Australia
Date submitted for ethics approval [1] 297258 0
14/12/2016
Approval date [1] 297258 0
09/01/2017
Ethics approval number [1] 297258 0
16/45

Summary
Brief summary
A single centre double blinded randomised control trial to determine if surgical TAP blocks provide any additional post-operative analgesic benefit compared with conventional oral analgesia for caesarean sections under spinal anaesthesia with intrathecal fentanyl.
100 term pregnant women undergoing elective caesarean delivery with spinal anaesthesia (2.2mL 0.5% hyperbaric bupivacaine and 15mcg fentanyl) are to be enrolled.
Patients will be randomly allocated to one of two groups of 50: they will either receive a surgical TAP block or no TAP block. In the relevant group the TAP block will be performed by the surgeon after closure of the uterus. Patient blinding will be maintained by use of the standard surgical drapes.
Data collection will be carried out by the acute pain service (APS) who will also be blinded when doing follow-up assessments of pain (visual analogue 0-100mm) scores (VAS) at 2, 6, 24 and 48 hours and cumulative oxycodone use at 2, 6, 24 and 48 hours.
The primary outcome will be the visual analogue scale (VAS) pain score (0-100mm) at six (6) hours post-operatively.
Secondary outcomes will be:
1. Rest and dynamic visual analogue scale (VAS) pain scores (0-100mm) at 2, 6, 24 and 48 hours post-operatively.
2. Oxycodone IR use at 2, 6, 24, and 48 hours
3. Patient satisfaction scores at 24 and 48 hours (10: completely satisfied, 1: completely dissatisfied).
4. Opioid-related adverse effects including sedation, nausea, vomiting, itch and constipation over 48 hours. Sedation (assessed by the Ramsay Sedation score 1-6). The remaining side effects are graded 0-3 where 0 is none, 1 is mild with no treatment required, 2 is moderate and treatment required and helpful and 3 is severe where treatment is required and not helpful. Constipation is assessed at 48 hours only.
5. Incidence of symptoms of local anaesthetic toxicity (perioral tingling, metallic taste, tinnitus, visual disturbance, slurred speech) at 2 hours.

Hypotheses
1. Surgical TAP blocks significantly reduce pain post LSCS under spinal anaesthesia as defined by reduced visual analogue scale (VAS) pain scores and oxycodone use at 2-48 hours and greater patient satisfaction scores compared to having only conventional analgesia.
2. Opioid-related adverse effects including post-operative nausea and vomiting (PONV), pruritus, sedation, constipation) by 48 hours post-operatively are reduced in the surgical TAP block groups compared to those receiving only standard care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73490 0
Dr James Griffiths
Address 73490 0
The Royal Women's Hospital
20 Flemington Road
Parkville
Victoria 3052
Country 73490 0
Australia
Phone 73490 0
+61 418306793
Fax 73490 0
Email 73490 0
jamesgriffiths@me.com
Contact person for public queries
Name 73491 0
Dr Thomas Callaghan
Address 73491 0
The Royal Women's Hospital
20 Flemington Road
Parkville
Victoria 3052
Country 73491 0
Australia
Phone 73491 0
+61 435882560
Fax 73491 0
Email 73491 0
tom_callag@hotmail.com
Contact person for scientific queries
Name 73492 0
Dr James Griffiths
Address 73492 0
The Royal Women's Hospital
20 Flemington Road
Parkville
Victoria 3052
Country 73492 0
Australia
Phone 73492 0
+61 418306793
Fax 73492 0
Email 73492 0
jamesgriffiths@me.com