Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000291381
Ethics application status
Approved
Date submitted
3/06/2008
Date registered
11/06/2008
Date last updated
9/11/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot Trial of Transversus Abdominis Plane Ropivacaine Infusions following Abdominal Surgery
Scientific title
The Analgesic Efficacy of Ultrasound Guided Transversus Abdominis Plane Ropivacaine Continuous Blockade in Patients Undergoing Abdominal Surgery - Pilot Trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Analgesia in patients undergoing abdominal surgery 3192 0
Post-operative analgesia in patients undergoing abdominal surgery 3193 0
Condition category
Condition code
Anaesthesiology 3355 3355 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transversus abdominis plane infusion using ropivacaine 0.2%, 0.1mL/kg/hr bilaterally. Infusion rate rounded down to the nearest integer. Maximum of 7mL/h bilaterally. 72 hr duration of infusion.
Intervention code [1] 2927 0
Prevention
Comparator / control treatment
uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4242 0
Patient controlled analgesia morphine cummulative requirement
Timepoint [1] 4242 0
48 hours post injection
Secondary outcome [1] 7165 0
Patient controlled analgesia morphine cummulative requirement in milligrams
Timepoint [1] 7165 0
6, 24 and 72 hours post injection
Secondary outcome [2] 7166 0
Functional Activity Score - patient self- assessed score with gradings as follows:
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] 7166 0
6, 24, 48 and 72 hours post injection
Secondary outcome [3] 7167 0
Verbal Pain Scores - patient self-assessed score from zero to 10, 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] 7167 0
6, 24, 48 and 72 hours post injection
Secondary outcome [4] 7168 0
Presence and severity of nausea and vomiting - patient self-assessed score with with gradings of none, mild, moderate or severe symptoms
Timepoint [4] 7168 0
6, 24, 48 and 72 hours post injection
Secondary outcome [5] 7169 0
Presence and severity of pruritus - patient self-assessed score with gradings of none, mild, moderate or severe symptoms
Timepoint [5] 7169 0
6, 24, 48 and 72 hours post injection
Secondary outcome [6] 7170 0
Presence and severity of sedation - investigator graded score with gradings as follows:
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] 7170 0
6, 24, 48 and 72 hours post injection
Secondary outcome [7] 7171 0
Plasma ropivacaine levels (Total and unbound fraction)
Timepoint [7] 7171 0
zero, 2, 6, 12, 24, 48, 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, laparoscopic assisted surgery

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3427 0
Hospital
Name [1] 3427 0
Western Health
Country [1] 3427 0
Australia
Primary sponsor type
Hospital
Name
Western Health
Address
Gordon St Footscray
VIC 3011
Country
Australia
Secondary sponsor category [1] 3069 0
Individual
Name [1] 3069 0
Elizabeth Hessian
Address [1] 3069 0
Department of Anaesthesia, Intensive Care and Pain Management
Western Health
Gordon St
Footscray
VIC 3011
Country [1] 3069 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5452 0
Melbourne Health HREC
Ethics committee address [1] 5452 0
Royal Melbourne Hospital
Grattan St
Parkville 3051
Ethics committee country [1] 5452 0
Australia
Date submitted for ethics approval [1] 5452 0
01/07/2008
Approval date [1] 5452 0
Ethics approval number [1] 5452 0
2008.137

Summary
Brief summary
This is a pilot trial looking at the safety and feasability of running a local anaesthetic infusion to improve the post-operative pain relief of patients who have had abdominal surgery. The local anaesthetic, called ropivacaine, will be run via a transversus abdominis plane catheter. This will be placed in both sides of the abdomen between two muscle layers. The study will look at the effect of the infusion on how much morphine the patient requires after their surgery. The study will also look at the levels of ropivacaine in the blood during the infusion, which will run for three days.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28620 0
Address 28620 0
Country 28620 0
Phone 28620 0
Fax 28620 0
Email 28620 0
Contact person for public queries
Name 11777 0
Dr Elizabeth Hessian
Address 11777 0
Department of Anaesthesia, Intensive Care and Pain Management
Western Health
Gordon St
Footscray
VIC 3011
Country 11777 0
Australia
Phone 11777 0
0431834636
Fax 11777 0
Email 11777 0
[email protected]
Contact person for scientific queries
Name 2705 0
Dr Elizabeth Hessian
Address 2705 0
Department of Anaesthesia, Intensive Care and Pain Management
Western Health
Gordon St
Footscray
VIC 3011
Country 2705 0
Australia
Phone 2705 0
0431834636
Fax 2705 0
Email 2705 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.