Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000099022
Ethics application status
Approved
Date submitted
27/01/2010
Date registered
1/02/2010
Date last updated
5/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Epidural vs Tranversus abdominis plane (TAP) Catheter for pain relief in Abdominal Surgery
Scientific title
Epidural Catheter Technique vs Transversus Abdominis Plane (TAP) Catheter Technique for Postoperative Analgesia after Abdominal Surgery; a Randomized Controlled Trial
Secondary ID [1] 1349 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative analgesia after abdominal surgery 256687 0
Condition category
Condition code
Anaesthesiology 256840 256840 0 0
Pain management
Surgery 256874 256874 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the EPIDURAL group the epidural catheter will be placed pre-operatively. Only a test block will be performed to ensure correct placement of the catheter. At the end of the case in the post anaesthetic care unit (PACU) a bolus of 8-15 ml of Ropicavaine 0.2% will be administered through the epidural catheter, followed by an infusion of 5-15 ml/hr (based on clinical effect) of Ropivacaine 0.2% for 3 days.

In TAP group bilateral catheters will be inserted in the transversus Abdominis Plane using an ultrasound guided approach at the end of the case, to avoid any interference with the surgical procedure. A 20 ml bolus of Ropivacaine 0.375% will be administered through each catheter, followed in the PACU by an infusion of 8 ml/hr of 0.2% Ropivacaine through each catheter for 3 days.
Intervention code [1] 255916 0
Prevention
Intervention code [2] 255917 0
Treatment: Drugs
Comparator / control treatment
The TAP technique will be compared to the Epidural technique (as the gold standard)
Control group
Active

Outcomes
Primary outcome [1] 257709 0
Postoperative Numerical Rating Pain Score
Timepoint [1] 257709 0
0 and 1 hr (in PACU), 24 hrs, 48 hrs, 72 hrs in posoperation.
Secondary outcome [1] 263055 0
Total postoperative Fentanyl use in PACU and postoperative ward
Timepoint [1] 263055 0
Over 72 hrs post operation
Secondary outcome [2] 263056 0
Satisfaction score (4-point Likert scale)
Timepoint [2] 263056 0
Day 3 (72 hrs)
1 Month post operation

Eligibility
Key inclusion criteria
Elective abdominal surgery
American society of anaesthesiologist(ASA) grade less then 4
Adequate English language skills
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Emergency surgery.
Allergy to local anaesthetic.
Pregnancy.
On regular opioid medication prior to surgery.
Mental handicap or psychiatric condition precluding adequate communication.
Spinal cord disorder, bleeding disorder, infection on the back.

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)
The trial will be introduced and discussed in Preadmission clinic. The patient information sheet will be provided at the time. Final consent will be obtained during the preadmission visit.
Allocation will be done by serially drawing a computer generated concealed randomisation envelop.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated (simple randomisation) enveloppes to be drawn serially by a non-investigator
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/02/2010
Actual
10/03/2010
Date of last participant enrolment
Anticipated
Actual
25/08/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256419 0
Hospital
Name [1] 256419 0
The Queen Elizabeth hospital
Country [1] 256419 0
Australia
Primary sponsor type
Hospital
Name
The Queen Elizabeth hospital
Address
28 woodville Rd
Woodville South SA 5011
Country
Australia
Secondary sponsor category [1] 255721 0
None
Name [1] 255721 0
Address [1] 255721 0
Country [1] 255721 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258469 0
Ethics of Human Research Committee
Ethics committee address [1] 258469 0
Ethics committee country [1] 258469 0
Australia
Date submitted for ethics approval [1] 258469 0
Approval date [1] 258469 0
12/01/2010
Ethics approval number [1] 258469 0
2009061

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

Contacts
Principal investigator
Name 30771 0
Dr vasanth rao kadam
Address 30771 0
Dept of Anaesthesia The Queen Elizabeth Hospital 28 Woodville Rd Woodville South SA 5011
Country 30771 0
Australia
Phone 30771 0
+610882226640
Fax 30771 0
Email 30771 0
[email protected]
Contact person for public queries
Name 14018 0
Dr Vasanth Rao
Address 14018 0
Dept of Anaesthesia
The Queen Elizabeth Hospital
28 Woodville Rd
Woodville South SA 5011
Country 14018 0
Australia
Phone 14018 0
+61 8 82226640
Fax 14018 0
+61 8 82227065
Email 14018 0
[email protected]
Contact person for scientific queries
Name 4946 0
Dr Vasanth Rao
Address 4946 0
Dept of Anaesthesia
The Queen Elizabeth Hospital
28 Woodville Rd
Woodville South SA 5011
Country 4946 0
Australia
Phone 4946 0
+61 8 82226640
Fax 4946 0
+61 8 82227065
Email 4946 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.