Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000915459
Ethics application status
Approved
Date submitted
3/07/2016
Date registered
11/07/2016
Date last updated
5/03/2019
Date data sharing statement initially provided
21/12/2018
Date results information initially provided
21/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison between Ultrasound Guided Abdominal Wall Catheter (by Anaesthetist) and Wound Catheter (by Surgeon) for the Treatment of Postoperative Pain after Abdominal Surgery
Scientific title
Transmuscular Quadratus Lumborum versus Pre-Peritoneal Catheters for Postoperative Analgesia in Abdominal Surgery
Secondary ID [1] 289541 0
NilKnown
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative Analgesia in Abdominal Surgery 299255 0
Condition category
Condition code
Anaesthesiology 299264 299264 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The two groups are Pre peritoneal(PP) and Trans-muscular Quadratus lumborum(TQL) group. Both groups will have standard General anesthesia. Both groups will have standard monitoring: involving ECG, pulse oximetr, capnography, noninvasive BP.,At the end of the surgery patients in the PP group, the surgeon will inject 20ml of 0.375% ropivacaine at subcutaneous, sub-fascial and pre-peritoneal level followed by catheter insertion under direct vision and connected to an elastomeric pump. In the TQL group anaesthetist performs the TQL block post-surgery in lateral position, Under aseptic precautions, ultrasound guidance, an 18 gauge Tuohy needle will be used to reach the QL muscle posterior aspect. This is confirmed by injecting saline and followed by a bolus dose of 20 ml of0.375% ropivacaine . Subsequently a catheter is inserted. The same technique is repeated on the other side. Both groups will receive multimodal analgesia which is part of Acute pain service(APS) hospital protocol. Which involves Paracetamol 1 gram 6hourly (IV/oral) and fentanyl PCA. Paracetamol will be administered IV if patient not tolerating orally at the discretion of treating physician. Fentanyl PCA device (bolus 10 to 40 mcg based on pain scores with lockout time 5 min) is managed at the discretion of APS staff. Both groups will be infused with 0.2% ropivacaine 5ml/hr on each side during 48 hours. Intervention will be adhered to the protocol in the single center at the hospital, which also include staff from the the pain service in the post operative period. APS personnel will independently assess the postoperative pain scores and analgesia used in recovery and on day one and two. Duration of introduction of catheter insertions and complications related to it will be noted. Patient satisfaction will be assessed on day 2 and during a follow-up telephone call at one month. First flatus or bowels opening time and discharge time will also be tracked. Personnel and material costs will be used for a cost analysis
Intervention code [1] 295136 0
Prevention
Intervention code [2] 295137 0
Treatment: Drugs
Comparator / control treatment
The comparator is Pre peritoneal catheter group.
Control group
Active

Outcomes
Primary outcome [1] 298840 0
Pain scores on cough in the post anaesthesia care unit
Timepoint [1] 298840 0
Pain scores on cough in the post anaesthesia care unit
Primary outcome [2] 298877 0
Pain scores on cough on day one and two
Timepoint [2] 298877 0
Post operative period on day one and two.
Data obtained from the review of medical records.
Secondary outcome [1] 325127 0
satisfaction scores ,
Likert score is used to assess patient satisfaction with the analgesic technique on the scale of 1-4.
Timepoint [1] 325127 0
on Day 2 and day 30 post surgery
Secondary outcome [2] 325128 0
The cost of the all consumables and time consumed by the staff .
Timepoint [2] 325128 0
First post operative week., data collected from patient medical records
Secondary outcome [3] 325384 0
Time to first passing of flatus or bowel movement.
Timepoint [3] 325384 0
At time of first passing of flatus or bowel movement. Data collected from the post operative visit on review of the medical records
Secondary outcome [4] 325385 0
discharge time
Timepoint [4] 325385 0
At time of hospital discharge. Data collected from the post operative visit on review of the medical records.
Secondary outcome [5] 325492 0
duration of introduction of catheter insertions,
Timepoint [5] 325492 0
outcome is assessed at the end of the surgical procedure on the operative day. This time is obtained from the observation sheet or review of medical records
Secondary outcome [6] 325515 0
Catheter related complications
Timepoint [6] 325515 0
At the end of 48 hours in the post-operative period from the pain or medical records
Secondary outcome [7] 326603 0
Dermatomes levels assessed by ice pack tested for cold sensation and test results. by review of medical records,
Timepoint [7] 326603 0
Recovery room on the operative day and day one
Secondary outcome [8] 367795 0
pain score at rest
Timepoint [8] 367795 0
in the immediate post operative period in PACU ( post anaesthesia care unit) and till day two
Secondary outcome [9] 367796 0
Analgesia use
Timepoint [9] 367796 0
Analgesia used in the immediate postoperative period in PACU (post anaesthesia care unit) till day 2

Eligibility
Key inclusion criteria
1.Elective abdominal surgery
2.Between 18 and 85 years of age
3.ASA less then 4
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
1.Emergency surgery
2.Allergy to local anaesthetic
3.Pregnancy
4.On regular opioid medication prior to surgery(>30mg/day)
5.Mental handicap or psychiatric condition precluding adequate communication

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)
Randomization will occur by random group allocations through a computer program (computerised sequence generation). This will provide group allocation concealed in sealed numbered opaque envelopes. Preoperatively the patients will not know which group they are allocated to. The medical staff involved in the treatment of the patient will not be blinded. We have decided not to use sham treatments due to additional time investment required, treatment related risks, and ethical considerations. As the employed techniques are essentially different, the assessors and APS staff will not be blinded either.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will occur by random group allocations through a computer program (computerised sequence generation). This will provide group allocation concealed in sealed numbered opaque envelopes. Preoperatively the patients will not know which group they are allocated to. The medical staff involved in the treatment of the patient will not be blinded. We have decided not to use sham treatments due to additional time investment required, treatment related risks, and ethical considerations. As the employed techniques are essentially different, the assessors and APS staff will not be blinded either
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Its a prospective study single blinded. The study is designed to recruit 82 patients; 41 in each arm of the study
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the statistical analysis of the data we will be using the following methods: Differences between the continuous variables by the “t”-test; categorical variables by Fisher's exact test; and the pain scores between groups (TQL vs PP) will be analysed by rank non-parametric methods (Man Whitney U test).
Sample size: There are no parallel trials available.Based on our previous report (Vasanth Kadam and John Moran, epidural infusions versus transversus abdominis plane (TAP) block infusions: retrospective study. Journal of Anesthesia 2011; 25 (5):786-787), the peak cough pain score (Numerical Rating Scores for Pain; NRS-P; 0-10) was noted to be 5(SD=3) and as appropriate randomised controlled trials for the use of QL blocks catheters have not been published, an approximate scenario was established for patient number: the total patient number (at 80% power) for a 2 point (40%) mean decrease in NRS was 72. On this basis, it was proposed to randomise 82 patients to the two treatment arms.Target sample size of 82 participants were considered appropriate with 41 in each arm.
A blinded interim analysis will be performed during the initial stage of progress of the study on completing 50 patients.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2016
Actual
3/11/2016
Date of last participant enrolment
Anticipated
Actual
17/09/2018
Date of last data collection
Anticipated
Actual
24/10/2018
Sample size
Target
82
Accrual to date
Final
82
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 6023 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [2] 6869 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 13454 0
5011 - Woodville
Recruitment postcode(s) [2] 14539 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 293920 0
Hospital
Name [1] 293920 0
Anaesthesia department, The Queen Elizabeth hospital
Country [1] 293920 0
Australia
Funding source category [2] 298470 0
Charities/Societies/Foundations
Name [2] 298470 0
Australian and New Zealand College of Anaesthetists
Country [2] 298470 0
Australia
Primary sponsor type
Hospital
Name
The Queen Elizabeth hospital
Address
The Queen Elizabeth hospital, 28 Woodville road, Woodville south.SA.5011.
Country
Australia
Secondary sponsor category [1] 292744 0
None
Name [1] 292744 0
not known
Address [1] 292744 0
Not known
Country [1] 292744 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295336 0
HUMAN RESEARCH ETHICS COMMITTEE (TQEH/LMH/MH)
Ethics committee address [1] 295336 0
BHI
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South SA 5011
Ethics committee country [1] 295336 0
Australia
Date submitted for ethics approval [1] 295336 0
29/07/2016
Approval date [1] 295336 0
21/09/2016
Ethics approval number [1] 295336 0

Summary
Brief summary
The investigators are proposing a prospective, randomized study of 2x41 patients undergoing major abdominal surgery to compare ultrasound-guided TQL block catheters versus surgically placed PP catheters as an active control-group. We have been conservative in estimating the number of patients required, as there are no parallel active trials in the literature to draw from. However a single study using single shot TQl block in the lower abdominal surgery found 25 patients sufficient to get power of 0.8.The study will be conducted with pain score on cough as primary measurable endpoint and Analgesic use as secondary endpoint (cumulative and daily -PACU, day 1, day 2- Fentanyl use) and pain score differences over time as secondary endpoint -PAC, day 1, day 2 at rest.The investigators hypothesize that ultrasound-guided TQL block is superior to surgically guided Pre-Peritoneal block with respect to both end-points and either technique may be superior in discharge times or cost-efficacy.
The primary objective of the study is to compare analgesia used and the pain scores with the ultrasound guided TQL vs. surgically placed PP catheter infusion techniques in abdominal surgery. Secondary aim is to assess the subjective quality of pain management (satisfaction score), discharge times and cost analysis of the two methods of delivery. Patients in the PP group will have PP catheters placed under direct vision by the surgeon at the end of the surgery. Initially the surgeon injects 20 ml ropivacaine 0.375% at each site; subcutaneous, sub-fascia and pre-peritoneal levels followed by catheter insertion. This catheter are connected to an elastomeric pump. In the TQL group post-surgery, with the patient in lateral position, under ultrasound guidance, an 18 gauge Tuohy needle will be used to reach the QL muscle posterior aspect. This is confirmed by injecting saline and followed by a bolus dose of 20 ml of ropivacaine 0.375%. Subsequently a catheter is inserted. The same technique is repeated on the other side. Both groups will receive multimodal analgesia with Paracetamol 1 gram QID (orally or IV) and a Fentanyl PCA device (bolus 10 to 40 mcg; lockout time 5 min). Both groups will be infused with 0.2% ropivacaine 5ml/hr on each side during 48 hours via elastomeric pump. Acute Pain Service (APS) personnel will independently assess the postoperative pain scores and analgesia used in recovery and on day one and two. Procedure related technical issues; duration of introduction of catheter insertions and complications related to it will be noted. Patient satisfaction will be assessed on day 2 and during a follow-up telephone call at one month. First flatus or bowels opening time and discharge time will also be tracked. Personnel and material costs will be used for a cost analysis.
Trial website
none
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66922 0
Dr Vasanth Rao Kadam
Address 66922 0
Anaesthesia department.The Queen Elizabeth hospital, 28 Woodville road. Woodville south. SA.5011
Country 66922 0
Australia
Phone 66922 0
+61 8 82226000
Fax 66922 0
+61 8 82227065
Email 66922 0
[email protected]
Contact person for public queries
Name 66923 0
A/Prof Van Wyjk Roelof
Address 66923 0
Head of Anaesthesia, Anaesthesia department. The Queen Elizabeth hospital, 28 Woodville road. Woodville south. SA.5011
Country 66923 0
Australia
Phone 66923 0
+61 8 82226000
Fax 66923 0
+61 8 82227065
Email 66923 0
[email protected]
Contact person for scientific queries
Name 66924 0
Dr Vasanth Rao Kadam
Address 66924 0
Anaesthesia department. The Queen Elizabeth hospital, 28 Woodville road. Woodville south. SA.5011
Country 66924 0
Australia
Phone 66924 0
+61 8 82226000
Fax 66924 0
+61 8 82227065
Email 66924 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.