Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000639628
Ethics application status
Approved
Date submitted
22/04/2014
Date registered
17/06/2014
Date last updated
18/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of transversus abdominis plane block continuous catheter infusion vs intermittent bolus dosing for postoperative pain relief in abdominal surgery.-Prospective randomised study.
Scientific title
Comparison Transversus abdominis plane block continuous catheter infusion vs intermittent bolus dosing for postoperative analgesia in abdominal surgery- Prospective randomized study.
Secondary ID [1] 284269 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Study of postoperative pain scores and analgesia between the groups 291399 0
Quality of pain relief(satisfaction scores) and cost of pain relief methods 291400 0
Condition category
Condition code
Anaesthesiology 292084 292084 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the continous group under ultrasound guidance TAP block performed and catheter inserted,thru the catheter the anaesthetist boluses ropivacaine 0.5% 20ml on each side, followed by ropivacaine 0.2% infusion @ 8ml/hr each side in recovery room till 48hrs. whereas in Intermittent group with same technique and same bolus dose as other gp but subsequent bolus of 0.2% ropivacaine 20ml each side delivered by pain service team at 8hours intervel till 48hrs.
Patients in both groups will be provided with Paracetamol 1 gram 4 times a day (orally or IV) and a Fentanyl PCA device (bolus 10 to 40 mcg; lockout time 5 min; no back-ground infusion) as part of a multimodal analgesic approach
Intervention code [1] 289228 0
Prevention
Intervention code [2] 289305 0
Treatment: Drugs
Comparator / control treatment
Under ultrsound guide, bilateral TAP block will be performed in both the groups.In the continous group the bolus dose of ropivacaine 0.5% 20ml on each side followed by ropivacaine 0.2% infusion @ 8ml/hr each side till 48hrs
Control group
Active

Outcomes
Primary outcome [1] 291958 0
Pain scores on the numerating scale of 0-10
Timepoint [1] 291958 0
at 1 hour, 24 hours and 48 hours
Primary outcome [2] 292049 0
other primary outcome would be analgesia used in the perioperativ period
Timepoint [2] 292049 0
time point in the immediate recovery period, at 24 hrs and 48hrs
Secondary outcome [1] 307925 0
Satisfaction scores
Likert scale for satisfaction with pain relief methods: 4 point rating used: 1. completely relieved; 2. relieved; 3. somewhat relieved; and 4. not relieved
Timepoint [1] 307925 0
on day 2 and 30 days
Secondary outcome [2] 308077 0
cost of consumables and labour
Timepoint [2] 308077 0
During the 48 hours
The cost of all the consumables and time consumed by the staff done by the nurse co-ordinator.
Secondary outcome [3] 308744 0
Discharge time
Timepoint [3] 308744 0
1st post operative week, data collected electronically fron hspital database

Eligibility
Key inclusion criteria
Inclusion Criteria:
Elective abdominal surgery
Between 18 and 85 years of age
ASA less then 4
Adequate English language skills
Minimum age
18 Years
Maximum age
85 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

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)
Transversus abdominis plane (TAP) block with catheter is inserted intra operatively in all cases but the method of local anaesthetic delivery in the post op period is either intermittent bolus or continous infusion group.
The allocation done by simple randomisation table created by computer software(computerised sequence generation). This allocation was concealed by sealed opaque envelope with numbered and group what alloted to .
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation done by simple randomisation table created by computer software(computerised sequence generation). This allocation was concealed by sealed opaque envelope with numbered and group what alloted to .
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Its a prospective study approximately 10 in each group,randomised controlled trial, with patient and data collecting person are blinded
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The data will be analysed using the following methods: differences between the
continuous variables by the “t”-test; categorical variables by Fisher's exact test. The pain scores between groups (Continuous vs Intermittent TAP) will be analysed by rank non-parametric methods (Man Whitney U test).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/12/2014
Actual
22/12/2014
Date of last participant enrolment
Anticipated
Actual
12/10/2015
Date of last data collection
Anticipated
Actual
12/11/2015
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 2353 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 8017 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 289121 0
Hospital
Name [1] 289121 0
ThE queen Elizabeth hospital
Self funded
Country [1] 289121 0
Australia
Primary sponsor type
Hospital
Name
The Queen Elizabeth hospital
Address
TQEH dept of anaesthesia
28 woodville rd
woodville 5011.SA
Country
Australia
Secondary sponsor category [1] 288119 0
None
Name [1] 288119 0
Address [1] 288119 0
Country [1] 288119 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290901 0
The Queen Elizabeth hospital Ethics committee
Ethics committee address [1] 290901 0
28 woodville rd
woodville 5011.SA
Ethics committee country [1] 290901 0
Australia
Date submitted for ethics approval [1] 290901 0
15/07/2014
Approval date [1] 290901 0
08/10/2014
Ethics approval number [1] 290901 0
HREC/14/TQEHLMH/116

Summary
Brief summary
This prospective study 0f 20 patients.In both the groups Bilateral TAP catheters will be placed using an ultrasound guided approach post-operatively with the bolus dose of 20 ml of 0.5% Ropivacaine bilaterally. In post anaesthetic care unit (PACU) an infusion of Ropicavaine 0.2% will be administered @ 8ml/hr for 2 days in the Continuous group. Whereas in Intermittent group only bolus doses 20ml 0.2% ropivacaine will be administered by the Acute pain service personnell every 8 hrly for 48 hrs.

Patients in both groups will be provided with Paracetamol 1 gram 4 times a day (orally or IV) and a Fentanyl PCA device (bolus 10 to 40 mcg; lockout time 5 min; no back-ground infusion) as part of a multimodal analgesic approach.

The following parameters will be registered:
Numerical Rating Scores for Pain (NRS-P; 0-10) at rest and on coughing in PACU at 0 and I hour and in the postoperative ward at 24 hrs, 48 hrs.
Fentanyl use in PACU and postoperative ward on day 1 & day 2.
Procedure related: material costs and other issues will be noted.
Any rescue medication used.
A 4 point ‘Likert’-scale will be used on day 2 and during a follow-up telephone call at one month to assess patient satisfaction with the analgesic technique used.
discharge time and cost analysis will be assessed.

All results will be recorded on a data collection sheet in a prospective fashion and subsequently entered in a protected database
Trial website
nil
Trial related presentations / publications
Presentation
E-poster moderated oral presentation at the Australian and New Zealand College of Anaesthetists and Faculty of Pain Medicine ASM 2016 held at the Aotea Centre, Auckland, New Zealand from April 30 – May 4.
Publication
Continuous transversus abdominis plane block vs intermittent bolus for analgesia after abdominal surgery: a randomized trial. Journal of Pain Research 2017:10 1705–1712.
Public notes

Contacts
Principal investigator
Name 46970 0
Dr vasanth rao kadam
Address 46970 0
The Queen Elizabeth hospital,dept of anaesthesia,
28 woodville rd, Woodville.5011 SA
Country 46970 0
Australia
Phone 46970 0
61882226000
Fax 46970 0
61882227065
Email 46970 0
[email protected]
Contact person for public queries
Name 46971 0
vasanth rao kadam
Address 46971 0
The Queen Elizabeth hospital,dept of anaesthesia,
28 woodville rd.Woodvile 5011.SA
Country 46971 0
Australia
Phone 46971 0
61882226000
Fax 46971 0
Email 46971 0
[email protected]
Contact person for scientific queries
Name 46972 0
Roelof Vanwijk
Address 46972 0
The Queen Elizabeth hospital. dept of anaesthesia,
28 woodville rd Woodville SA 5011
Country 46972 0
Australia
Phone 46972 0
61882226000
Fax 46972 0
61882227065
Email 46972 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
SourceTitleYear of PublicationDOI
EmbaseContinuous transversus abdominis plane block vs intermittent bolus for analgesia after abdominal surgery: A randomized trial.2017https://dx.doi.org/10.2147/JPR.S132891
N.B. These documents automatically identified may not have been verified by the study sponsor.