Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000554561
Ethics application status
Approved
Date submitted
7/05/2015
Date registered
29/05/2015
Date last updated
18/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Painbuster rectus sheath infusion device for analgesia following laparotomy
Scientific title
Do patients undergoing major abdominal surgery benefit from use of the Painbuster rectus sheath infusion device for improving analgesia or reducing opioid requirement in the post-operative period, a double blinded placebo controlled trial.
Secondary ID [1] 286658 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative pain 294990 0
Laparotomy 295051 0
Analgesia 295052 0
Condition category
Condition code
Anaesthesiology 295255 295255 0 0
Pain management
Surgery 295303 295303 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
IAll patients eliglble for the study will have a painbuster rectus sheath infusion catheter inserted by the surgeon at the end of surgery. This will be initially bolused with 30ml of 0.2% ropivacaine in all patients. Patients will then be randomized to have the painbuster elastometric pump either filled with normal saline, 0.2% ropivacaine, or 0.5% ropivacaine, and pain scores, opioid consumption, length of hospital stay, time to first eating and mobilisation and presence of side effects will be recorded. The elastometric pump will contain 400ml of fluid (either normal saline or ropivacaine) and this is infused at 4ml an hour for 100 hours following surgery. There are 2 rectus sheath catheters inserted by the surgeon and each catheter runs at a non-titrable rate of 2ml/hr via the elastometric pump. Compliance to use of the painbuster pump and time at discontinuation will be monitored by the pain team who will be responsible for follow up and data collection for the study patients.
Intervention code [1] 291802 0
Treatment: Devices
Intervention code [2] 291844 0
Treatment: Drugs
Comparator / control treatment
Control group - Placebo (normal saline)
The elastometric pump provides a non-titrable rate of 2ml/hr down each of the 2 rectus sheath catheters. The pump is left in situ until it is empty (it is filled with 400ml of fluid so this takes 100 hours).
Control group
Placebo

Outcomes
Primary outcome [1] 295003 0
Pain scores following surgery
Timepoint [1] 295003 0
Worst pain score daily for the first 4 days post surgery using an 11-point likert scale from 0 = no pain to 10 = worst pain imaginable
Primary outcome [2] 295041 0
Opioid consumption following surgery
Timepoint [2] 295041 0
For 100 hours following surgery converted to mg of morphine equivalents
Secondary outcome [1] 314555 0
Length of hospital stay as determined by the electronic hospital record that records admission and discharge times.
Timepoint [1] 314555 0
Hospital discharge.
Secondary outcome [2] 314657 0
Time to first mobilisation as assessed by the physio who makes daily assessments of each patient.
Timepoint [2] 314657 0
Within the first 4 days post-surgery.
Secondary outcome [3] 314658 0
Time to first solid food intakeas assessed by the nursing staff and the patient.
Timepoint [3] 314658 0
During the hospital stay.
Secondary outcome [4] 314659 0
Presence of opioid related side effects as assessed by the pain team on their daily assessment of the patient.
Timepoint [4] 314659 0
Daily for the first 4 days post-surgery

Eligibility
Key inclusion criteria
Age 18-80
Midline laparotomy
Planned painbuster device as part of analgesic regimen
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusions would be patient refusal,
plan for epidural analgesia and inability to follow up the patient i.e. not able to communicate for any reason (dementia, not able to speak English) and expected ICU admission following surgery.

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)
Patients will be approached by research staff pre-operatively and the trial explained and written consent sort. The surgical team and the people doing the follow up (done by the pain service) will be blinded to the group allocation. There will be 3 separate data collection forms, entitled study group one, study group two or study group three, 40 of each of these will be placed into 120 envelopes and when a patient consents to the study, an envelope will be randomly drawn from a box. The anaesthetic technicians are currently responsible for setting up the painbuster pumps by filling them with ropivacaine, they will be only people aware of the group allocation, and fill the pumps accordingly.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation of an envelope which will contain the group allocation. Group allocation will be placed in the envelope (control, 0.2% ropivacaine, or 0.5% ropivacaine ), the envelopes will then be thoroughly shuffled and divided into 3 and placed in the recovery rooms of both levels of our theatre block.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power calculation derived from previously published data indicates a sample size of 35 in each group to show a 30% difference in opioid use and pain scores. The target is for 40 patients to be recruited in each group. Continuous data will be compared with a two-tailed students T test, and categorical data will be compared with chi-squared test. Any differences between the 3 groups will be analysed by a 3 way ANOVA test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/06/2015
Actual
10/11/2015
Date of last participant enrolment
Anticipated
2/03/2018
Actual
23/10/2017
Date of last data collection
Anticipated
Actual
28/10/2017
Sample size
Target
110
Accrual to date
Final
110
Recruitment outside Australia
Country [1] 6863 0
New Zealand
State/province [1] 6863 0
Waikato

Funding & Sponsors
Funding source category [1] 291234 0
Hospital
Name [1] 291234 0
Waikato hospital
Country [1] 291234 0
New Zealand
Primary sponsor type
Hospital
Name
Waikato hospital
Address
Pembroke Street
Hamilton 3204
Country
New Zealand
Secondary sponsor category [1] 289909 0
None
Name [1] 289909 0
Address [1] 289909 0
Country [1] 289909 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292793 0
HDEC
Ethics committee address [1] 292793 0
Ethics committee country [1] 292793 0
New Zealand
Date submitted for ethics approval [1] 292793 0
12/05/2015
Approval date [1] 292793 0
02/09/2015
Ethics approval number [1] 292793 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 447 447 0 0
/AnzctrAttachments/368504-Painbuster_study[1].docx

Contacts
Principal investigator
Name 57074 0
Dr Kelly Byrne
Address 57074 0
C/- Anaesthetic department
Waikato hospital
Pembroke Street
Hamilton 3204
Country 57074 0
New Zealand
Phone 57074 0
+642102224390
Fax 57074 0
Email 57074 0
[email protected]
Contact person for public queries
Name 57075 0
Kelly Byrne
Address 57075 0
C/- Anaesthetic department
Waikato hospital
Pembroke Street
Hamilton 3204
Country 57075 0
New Zealand
Phone 57075 0
+642102224390
Fax 57075 0
Email 57075 0
[email protected]
Contact person for scientific queries
Name 57076 0
Kelly Byrne
Address 57076 0
C/- Anaesthetic department
Waikato hospital
Pembroke Street
Hamilton 3204
Country 57076 0
New Zealand
Phone 57076 0
+642102224390
Fax 57076 0
Email 57076 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.