Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000297325
Ethics application status
Not yet submitted
Date submitted
14/03/2008
Date registered
16/06/2008
Date last updated
16/06/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
The Analgesic Efficacy of Ultrasound-Guided Transversus Abdominis Plane Blocks after Abdominal Surgery
Scientific title
The Analgesic Efficacy of Ultrasound Guided Transversus Abdominis Plane (TAP) blocks compared with Placebo in Patients Undergoing Abdominal Surgery
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Analgesia in patients undergoing abdominal surgery 2927 0
Condition category
Condition code
Anaesthesiology 3065 3065 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transversus abdominis plane injection using ropivacaine 0.5%, 20ml bilaterally at the completion of surgery prior to waking from anaesthesia
Intervention code [1] 2658 0
Treatment: Other
Comparator / control treatment
Transversus abdominis plane block using normal saline, 20ml injected bilaterally into the Transversus Abdominis Plane at the completion of surgery prior to waking from anaesthesia
Control group
Placebo

Outcomes
Primary outcome [1] 3949 0
Patient controlled analgesia morphine cummulative requirement measured in milligrams of morphine required
Timepoint [1] 3949 0
48 hours post injection
Secondary outcome [1] 6630 0
Patient controlled analgesia morphine cummulative requirement measured in milligrams of morphine required. There is only one primary outcome, being the 48 hour morphine requirement. This is because the sample size for the trial has been calculated using 48 hour morphine requirements. The morphine requirements at the other timepoints are secondary outcomes.
Timepoint [1] 6630 0
6, 24 and 72 hours post injection
Secondary outcome [2] 6631 0
Functional Activity Score. This is a patient self-assessed score with the following gradings:
1. no limitation - activity is unrestricted by pain
2. mild limitation - activity is mild to moderately restricted by pain
3. severe limitation - the ability to perform the activity is severely limited by pain.
Timepoint [2] 6631 0
6, 24, 48 and 72 hours post injection
Secondary outcome [3] 6632 0
Verbal Pain Scores (VPS). Patients rate their pain from zero to ten, with zero representing no pain and ten representing worst pain ever experienced. Patients will be asked to note their VPS at rest and on movement or coughing.
Timepoint [3] 6632 0
6, 24, 48 and 72 hours post injection
Secondary outcome [4] 6633 0
Presence and severity of nausea and vomiting. A patient assessed score with none, mild, moderate or severe symptoms recorded.
Timepoint [4] 6633 0
6, 24, 48 and 72 hours post injection
Secondary outcome [5] 6634 0
Presence or absence of pruritis (itch). A yes/no question answered by the patient.
Timepoint [5] 6634 0
6, 24, 48 and 72 hours post injection
Secondary outcome [6] 6635 0
Presence and severity of sedation. This is a score with the following gradings:
0 ALERT
1 MILD: Sometimes drowsy, easy to rouse and can stay awake once woken
2 MODERATE: Constantly drowsy, still easy to rouse, unable to stay awake once woken
3 SEVERE: Constantly drowsy (somnolent), difficult to rouse, severe respiratory depression
Timepoint [6] 6635 0
6, 24, 48 and 72 hours post injection

Eligibility
Key inclusion criteria
Age over 18 years
Elective or semi-elective abdominal surgery requiring mid-line incision
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient refusal
Acute abdomen
A clinical history consistent with opioid tolerance including preoperative opioid consumption of longer than one week, intravenous opioid drug use
Preoperative use of opioid antagonists like buprenorphine and naltrexone
A clinical history of chronic pain, where patients may benefit from early commencement of agents like ketamine
Renal impairment with creatinine clearance less than 60 mL/min
Drug allergy or contraindication to morphine, ropivacaine, paracetamol
Anaesthetist preference for placement of central neuroaxial blockade/catheter
Surgeon refusal to placement of catheters
Inability of patient to use patient controlled analgesia pump post-operatively or to understand grading of pain via verbal pain score

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential trial patients will be identified in the pre-admission clinic (PAC), and the trial discussed with them there by one of the researchers. If they consent to participation, or express an interest in considering participation, a notifying page will be placed in the admission notes. This will alert staff to the presence of a trial patient once they are admitted, and trigger a call to the Acute Pain Management Service (ACPM). The ACPM nurse will then coordinate with the treating anaesthetist to facilitate trial inclusion. The elective surgical lists will also be examined to find patients who will be having abdominal surgery requiring mid-line laparotomy in case the patient has not attended PAC. Additionally, non-elective surgery patients will also be targeted if the urgency of the surgery or the clinical state of the patient does not preclude discussion of the trial.
A recruitment log will be kept of all patients identified for participation.
Randomisation Procedure: When a patient is recruited to the trial they will be assigned a unique five digit code. The first digit of the code will represent the hospital pharmacy preparing their test solution: 1 for Western Hospital and 2 for RMH. The next three digits will represent the patient number for that hospital. The last digit will be a check digit, being the last digit of the sum of the previous three numbers. This will allow a check that transcription of the code number from the test solution to the patient protocol has been accurate.
Each hospital pharmacy will have a master list of all patient codes. Each patient code will have been matched to one of two patient groups: ropivacaine or saline. This randomisation will have been performed using a computer random number generator. The pharmacy will use this list to prepare test solutions, labelled with the unique identifying patient code, and further marked with ‘one of two’ or ‘two of two’, on each of the patient’s syringes.
After a patient is recruited, pharmacy will be notified to allow the designated test solution to be brought to theatre. This will allow the TAP injection to be performed at the completion of surgery prior to waking the patient.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer random number generator will produce a list of numbers between 0 and 1. Those numbers between 0 and 0.5 will be assigned ropivacaine. Those numbers between 0.5 and 1 will be assigned saline.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3180 0
Charities/Societies/Foundations
Name [1] 3180 0
Australian and New Zealand College of Anaesthetists (ANZCA)
Country [1] 3180 0
Australia
Primary sponsor type
Individual
Name
Dr Elizabeth Hessian
Address
197 Roden St
West Melbourne
VIC 3003
Country
Australia
Secondary sponsor category [1] 2849 0
Hospital
Name [1] 2849 0
Western Hospital Dept Anaesthesia, Intensive Care and Pain Management
Address [1] 2849 0
Gordon St
Footscray
VIC 3011
Country [1] 2849 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5496 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 5496 0
Ethics committee country [1] 5496 0
Australia
Date submitted for ethics approval [1] 5496 0
01/07/2008
Approval date [1] 5496 0
Ethics approval number [1] 5496 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28437 0
Address 28437 0
Country 28437 0
Phone 28437 0
Fax 28437 0
Email 28437 0
Contact person for public queries
Name 11594 0
Dr Elizabeth Hessian
Address 11594 0
Western Hospital Department of Anaesthesia, Intensive Care and Pain Management
Gordon St
Footscray
VIC 3011
Country 11594 0
Australia
Phone 11594 0
0431834636
Fax 11594 0
Email 11594 0
[email protected]
Contact person for scientific queries
Name 2522 0
Dr Elizabeth Hessian
Address 2522 0
Western Hospital Department of Anaesthesia, Intensive Care and Pain Management
Gordon St
Footscray
VIC 3011
Country 2522 0
Australia
Phone 2522 0
0431834636
Fax 2522 0
Email 2522 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.