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Description of intervention(s) / exposure:
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Ultrasound guided transversus abdominis plane (TAP) block with local anaesthetic. At the end of the caesarean section, a TAP block will be performed with either local anaesthetic or placebo.
TAP block technique
Equipment
Ultrasound – 38mm linear array probe 13-6MHz
22G 150mm Stimuplex needle
Study drug – 40ml of 0.5% ropivacaine / saline
Betadine antiseptic preparation for skin preparation
Pulse oximetry to measure heart rate
Availability of full monitoring and resuscitation equipment
Identification of landmarks
Ultrasound positioned in the mid axillary line in the axial plane half way between the iliac crest and the costal margin.
Structures to be identified: subcutaneous fat, external oblique muscle, internal oblique muscle, transversus abdominis muscle, peritoneum and intraperitoneal structures. As a means of confirmation, the transversus abdominis tends to be darker and less echogenic.
If these are not readily identified, the probe may be moved posteriorly to identify the latissimus dorsi muscle which is external to the fascial extension of these muscles. The probe may also be moved anteriorly to the rectus sheath and the fascial planes followed back out laterally. The final position of the probe is to be no further anterior than the anterior axillary line. Oblique angulation may assist with identifying the planes.
Landmarks are to be classified as 'unsatisfactory' if any of 1. external oblique, 2. internal oblique, 3. transversus abdominis, or 4. intraperitoneal structures cannot be identified posterior to the anterior axillary line. The block may still be performed if the investigator is satisfied that the transversus abdominis muscle can be differentiated. Views will be considered ‘excellent’ if quadratus lumborum can be seen in addition to the above four structures.
If landmark identification is impossible, the block will not be performed.
Needle technique
The needle is inserted 'in plane' and directed to lie between the internal oblique and transversus abdominis under real time ultrasound guidance.
To confirm location, 2ml of local anaesthetic can be injected.
Once position is satisfactory, local anaesthetic is then injected in 5ml aliquots with aspiration between injection to a total of 20ml each side. Appropriate placement will be judged as production of an echolucent plane between the two muscles. Visible separation of muscle bundles of the internal oblique considered superficial placement. Separation of muscle bundles of the transversus abdominis indicates deep placement. Superficial or deep placement requires the needle to be repositioned.
Intervention drug
The active treatment arm will receive 20ml of 0.5% ropivacaine on each side (total 200mg ropivacaine). The placebo arm will receive 20ml saline on each side. The local anaesthetic duration of action is expected to be between 12 and 24 hours.
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| Intervention code: | Treatment: drugs |
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Comparator / control treatment:
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Ultrasound guided transversus abdominis plane block with inactive placebo (saline) at the end of the caesarean section.
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Control group: |
Placebo |
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Page 5
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Key inclusion criteria:
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Patients having elective caesarean sections under spinal or combined spinal epidural anaesthesia. |
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Reason:
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Minimum Age:
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18
Years
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Maximum Age:
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No limit
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Gender:
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Females |
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Healthy volunteers?
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No |
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Key exclusion criteria:
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Conditions associated with opioid tolerance: regular opioid analgesia use in the last three months, previous intravenous (IV) drug use
Transversus abdominis plane block technically difficult to perform: obesity (body mass index (BMI) > 35)
Contraindication to TAPB: local sepsis, local anaesthetic allergy, abnormal anatomy preventing spread of local anaesthetic (for example nephrectomy scars)
Contraindications to non-steroidal anti-inflammatory drugs: renal dysfunction, peptic ulcer disease, aspirin sensitive asthma, pregnancy induced hypertension/pre-eclampsia
Contraindications to neuraxial anaesthesia
Planned general anaesthesia
Risk of local anaesthetic toxicity: booking-in weight less than 50kg. Other local anaesthetic administration. |
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Page 6
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Study type: |
Interventional |
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Reason:
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Purpose of the study: |
Treatment |
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Allocation to intervention: |
Randomised controlled trial |
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures): |
All patients undergoing elective caesarean section at the Mater Mothers' Public and Private Hospital are eligible.
When patients are booked for elective caesarean section in the obstetric clinics, they receive the information sheet about this research.
An opportunity is given to all patients to discuss the study before the day of surgery with an anaesthetist. This occurs either at the anaesthetic clinic or by telephone interview. Patients are then be approached on the day of surgery in the admissions area by the investigator.
Allocation to placebo or treatment group is by sequentially numbered syringes filled with either placebo or local anaesthetic by the pharmacy. |
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation): |
Random order generation is by block randomisation using a randomisation table. |
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Masking / blinding: |
Blinded (masking used) |
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Who is/are masked/blinded: |
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
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Assignment: |
Parallel |
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Type of endpoint(s): |
Efficacy |
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Page 7
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Phase |
Phase 4 |
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Anticipated or actual start date: |
1/09/2008 |
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Target sample size: |
50 |
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Recruitment status: |
Completed |
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Page 8
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| Funding source 1: | Commercial sector/Industry |
| Name: | AstraZeneca |
| Address: | 5 Alma Road
North Ryde 2113 |
| Country: | Australia |
| Funding source 2: | Hospital |
| Name: | Mater Misericordiae Health Services Brisbane Ltd |
| Address: | Raymond Terrace
South Brisbane Qld 4101 |
| Country: | Australia |
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Primary sponsor: |
Hospital |
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Name: |
Mater Misericordiae Health Services Brisbane Ltd |
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Address: |
Raymond Terrace
South Brisbane Qld 4101 |
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Australia |
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| Secondary sponsor: | None |
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Page 9
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Has the study received approval from at least one ethics committee? |
Yes |
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Reason:
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| Ethics Committee name: | Mater Health Services Human Research Ethics Committee |
| Address: | Rm 235
Level 2 Aubigny Place
Raymond Terrace
South Brisbane QLD 4101 |
| Country: | Australia |
| Date of approval: | 23/04/2008 |
| HREC Number: | 1994M |
| Countries of recruitment: | Australia |
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Brief summary: |
The transversus abdominis plane (TAP) block is a local anaesthetic technique that has been developed in recent years for pain relief after abdominal surgey. It has been shown to work after caesarean delivery when performed by skilled operators. We aim to test an ultrasound guided approach to this block for pain relief after caesarean section. Women having elective caesarean sections will be randomly allocated to receive an ultrasound guided TAP block with local anaesthetic or placebo in addition to standard pain relief including morphine. We hope to find women who receive the local anaesthetic have better pain relief, need less morphine and have fewer side effects from morphine after caesarean section. |
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Trial website: |
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Presentations / publication list: |
Presented at the Australia and New Zealand College of Anaesthetists Annual Scientific Meeting in Cairns 2009.
Published:
Ultrasound-guided transversus abdominis plane block for analgesia after Caesarean delivery
D. Belavy; P. J. Cowlishaw; M. Howes; F. Phillips
British Journal of Anaesthesia 2009; doi: 10.1093/bja/aep235 |
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Page 10
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Contact person for public queries
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Name: |
Dr Phillip Cowlishaw |
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Address: |
Mater Misericordiae Health Services Brisbane Ltd
Raymond Terrace
South Brisbane Qld 4101 |
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Australia |
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Tel: |
07 31638646 |
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Email: |
phillip.cowlishaw@mater.org.au |
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Contact person for scientific queries |
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Name: |
Dr Phillip Cowlishaw |
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Address: |
Mater Misericordiae Health Services Brisbane Ltd
Raymond Terrace
South Brisbane Qld 4101 |
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Australia |
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07 31638646 |
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Email: |
phillip.cowlishaw@mater.org.au |
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Contact person responsible for updating information |
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Name: |
Dr David Belavy |
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Address: |
Mater Misericordiae Health Services Brisbane Ltd
Raymond Terrace
South Brisbane Qld 4101 |
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Australia |
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07 31638646 |
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Email: |
david.belavy@mater.org.au |
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International Committee of Medical Journal Editors (ICMJE): June 2007 editorial
International Committee of Medical Journal Editors (ICMJE): May 2005 editorial
WHO International Clinical Trials Registry Platform (ICTRP)
The World Health Organization announces new standards for registration of all human medical research
WHO trial registration data set
NHMRC Clinical Trials Centre
National Health and Medical Research Council (NHMRC) information about the ANZCTR
Frequently Asked Questions about the ANZCTR
About the ANZCTR
How to register a trial
How to update a trial