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Trial registered on ANZCTR


Registration number
ACTRN12617001448336
Ethics application status
Approved
Date submitted
28/09/2017
Date registered
12/10/2017
Date last updated
12/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised single blinded trial of surgically placed pre-peritoneal vs ultrasound placed rectus sheath catheters post laparotomy.
Scientific title
Randomised single blinded trial of surgically placed pre-peritoneal vs ultrasound placed rectus sheath catheters post laparotomy.
Secondary ID [1] 293002 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative Pain Management 304915 0
Condition category
Condition code
Anaesthesiology 304242 304242 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. All patients recruited (undergoing a laparotomy) will be randomised into two groups either receiving a rectus sheath catheter inserted by a General Surgeon intra-operatively into the pre-peritoneal space under direct visualisation or by an Anaesthetist into the intra-fascicular space via ultrasound guidance post-operatively.

2. Rectus sheath catheters placed by General Surgery will be on completion of the operation, prior to closure of the laparotomy wound. Anaesthetic placement of rectus sheath catheters will be at the end of the entire operation, prior to waking the patient up from general anaesthetic. Devices by both arms are standardised to 16G 110mm Touhy Needle, 16G Epidural catheter (multiperforated with 3 lateral eyes), 16/17G LOCKIT PLUS regional anaesthesia catheter securement device, ALARIS PRODUCTS 0.2microm Line Filters, 20ml Luer-lock syringe, Opsite Flexigrid (10X12cm). In regards to adherence and standardisation of procedure, prior to commencement of this study, consultant general surgeons and anaesthetists performing rectus sheath catheter insertions will be given a information session on placement of these catheters, equipments to be used and dosage of local anaesthetic to be infused (0.2% : 10-20mg/hr for up to 72hrs). These educational sessions will be led by the director of surgery and anaesthetics.
Intervention code [1] 299242 0
Treatment: Surgery
Comparator / control treatment
Control Group would be the General Surgical arm of the study whereby the rectus sheath catheters are inserted by a general surgeon intra-operatively into the pre-peritoneal space under direct visualisation.
Control group
Active

Outcomes
Primary outcome [1] 303527 0
Narcotic Usage (Will be calculated to equivalents of morphine)
Timepoint [1] 303527 0
The total duration the rectus sheath catheters remain in-situ is 72 hours. This is the primary time-point of the study.

Secondary outcome [1] 339201 0
Time taken for procedure (insertion of rectus sheath catheters by both arms). The time will be recorded by the General Surgical Team and the assisting nursing staff present as part of the final surgical check and count once the rectus sheath catheter equipment has been set aside for either surgical placement intraoperatively or by anaesthetic placement at the end of the procedure.

Timepoint [1] 339201 0
Minutes
Secondary outcome [2] 339204 0
Patient blinded VAS scores at rest and coughing (0-10)
Timepoint [2] 339204 0
3 days. This will be assessed and documented at 6 hour intervals for 72 hrs.
Secondary outcome [3] 339206 0
Time till flatus (Days)- Patients will be asked on review if they have had a bowel motion.

Timepoint [3] 339206 0
Measured in days:This will be recorded as within 24 (day 1) or 48 (day 2) or 72 hours (day 3).
Secondary outcome [4] 339207 0
Time till bowels open. Patients will be asked on review if they have had a bowel motion.

Timepoint [4] 339207 0
Measured in days:This will be recorded as within 24(day 1) or 48 (day 2) or 72 hours (day 3).
Secondary outcome [5] 339208 0
Time till discharge from hospital. Once the 72 hours of data collection is over, patients recruited in the study will be reviewed via chart review for the first six months.

Timepoint [5] 339208 0
Measured in days:This will be recorded as within 24(day 1) or 48 (day 2) or 72 hours (day 3).
Secondary outcome [6] 339209 0
These will be assessed by review of medical records. All patients recruited into the study will undergo a chart review for the first 6 months to ensure these complications (if present) are not missed.
Complications
o Wound infection
o UTI
o VTE
Timepoint [6] 339209 0
While an inpatient, patients will be reviewed daily and complications such as wound infection, UTI and VTE are assessed directly. On discharge patients will be monitored via chart review for the first 6 months ensuring delayed complications such as VTE is recorded as these complications are managed as an outpatient in the general practice setting.

Eligibility
Key inclusion criteria
All adult general surgical patients undergoing a midline laparotomy at Mackay base hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Local Anaesthetic allergy
- Catheter plastic allergy
- Multiple operations as defined as alteration of anatomy of the abdominal wall, preventing placement of catheters.
- Chronic abdominal pain as defined as abdominal pain with opiate use for > 12 weeks
- Abdomen left open
- Patient under 18 years of age
- Pregnant
- Inability of surgical/anaesthetic staff to perform procedure
- Patients with altered cognition (dementia or delirium) and therefore unable to respond to VAS.
- Patients intubated & therefore unable to communicate

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)
Seal Opaque Envelops
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Single Randomisation created by a computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Calculation of the sample size was performed by using the primary endpoint of 72-hour total morphine usage post laparotomy. In a similar previous study, the total dose of administered morphine was 62mg with a standard deviation of 16mg. It was decided that a difference of 20% (12mg) would be considered clinically relevant, similar to this previous study.
Assuming a = 0·05 and ß = 0·15 (a power of 85 per cent), a total of 66 patients (33 patients per group) would be required to needed to find there was no difference between each group. Assuming a 10% dropout rate 72 patients need to be recruited (36 patients per group) to make this number.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/11/2017
Actual
Date of last participant enrolment
Anticipated
28/12/2018
Actual
Date of last data collection
Anticipated
5/01/2019
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 9120 0
Mackay Base Hospital - Mackay
Recruitment postcode(s) [1] 17626 0
4740 - Mackay

Funding & Sponsors
Funding source category [1] 297628 0
Hospital
Name [1] 297628 0
Mackay Base Hospital
Country [1] 297628 0
Australia
Primary sponsor type
Hospital
Name
Mackay Base Hospital
Address
475 Bridge Road West Mackay, Mackay 4740, Queensland, Australia.
Country
Australia
Secondary sponsor category [1] 296649 0
None
Name [1] 296649 0
Address [1] 296649 0
Country [1] 296649 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298716 0
Townsville Hospital & Health Services Human Research Ethics Committee
Ethics committee address [1] 298716 0
Ethics committee country [1] 298716 0
Australia
Date submitted for ethics approval [1] 298716 0
24/04/2017
Approval date [1] 298716 0
31/08/2017
Ethics approval number [1] 298716 0
HREC/17/QTHS/59

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2086 2086 0 0
/AnzctrAttachments/373735-HREC17QTHS59_4 Approved.pdf (Ethics approval)
Attachments [2] 2087 2087 0 0
/AnzctrAttachments/373735-RCT Protocol V3 .pdf (Protocol)

Contacts
Principal investigator
Name 77998 0
Dr Pranav Divakaran
Address 77998 0
Mackay Base Hospital
475 Bridge Road West Mackay
4740 Queensland
Country 77998 0
Australia
Phone 77998 0
+617 4885 6000
Fax 77998 0
Email 77998 0
[email protected]
Contact person for public queries
Name 77999 0
Pranav Divakaran
Address 77999 0
Mackay Base Hospital
475 Bridge Road West Mackay
4740 Queensland
Country 77999 0
Australia
Phone 77999 0
+617 4885 6000
Fax 77999 0
Email 77999 0
[email protected]
Contact person for scientific queries
Name 78000 0
Pranav Divakaran
Address 78000 0
Mackay Base Hospital
475 Bridge Road West Mackay
4740 Queensland
Country 78000 0
Australia
Phone 78000 0
+617 4885 6000
Fax 78000 0
Email 78000 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
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Documents added automatically
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