Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000246088
Ethics application status
Approved
Date submitted
16/11/2007
Date registered
24/03/2010
Date last updated
12/09/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
SUSTAIN For PAIN
Scientific title
SUSTAIN For PAIN: Subcostal UltraSound guided Transversus Abdominis plane INfusions for Pain relief of Abdominal INcisions
Secondary ID [1] 1520 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative laparotomy patients 2556 0
Condition category
Condition code
Anaesthesiology 2658 2658 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ropivacaine Transversus Abdominis Plane infusion at a rate of 0.1ml/kg/hr bilaterally up to a maximum of 7ml/hr bilaterally via transversus abdominis plane catheter for 48 hours. The infusion rate will be rounded down to the nearest integer (e.g. a 68 kg patient will receive an infusion rate of 6 ml/hr bilaterally).
Intervention code [1] 2289 0
Treatment: Drugs
Comparator / control treatment
Normal saline Transversus abdominis plane infusion at a rate of 0.1ml/kg/hr bilaterally up to a maximum of 7ml/hr bilaterally via transversus abdominis plane catheter for 48 hours. The infusion rate will be rounded down to the nearest integer (e.g. a 68 kg patient will receive an infusion rate of 6 ml/hr bilaterally).
Control group
Placebo

Outcomes
Primary outcome [1] 257993 0
The primary endpoint of the trial will be the ratio of total morphine administration between 24-48 hours postoperatively and 0-24 hours post-operatively.
Timepoint [1] 257993 0
48 hrs post-operatively.
Secondary outcome [1] 5971 0
A sedation score greater greater than 2.
Sedation scores will be noted, with gradings as follows:
0 = alert.
1 = mild: Sometimes drowsy, easy to rouse and can stay awake once woken.
2 = moderate: Constantly drowsy, still easy to rouse, unable to stay awake once woken.
3 = severe: Constantly drowsy (somnolent), difficult to rouse, severe respiratory depression.
Timepoint [1] 5971 0
6 hours, 24 hours, and 48 hours post-operatively.
Secondary outcome [2] 5972 0
Presence or absence of nausea and/or vomiting in the interval prior to assessment will be noted.
Timepoint [2] 5972 0
6 hours, 24 hours, and 48 hours post-operatively.
Secondary outcome [3] 5973 0
Presence or absence of pruritis (itch). A yes/no question answered by the patient.
Timepoint [3] 5973 0
6 hours, 24 hours, and 48 hours post-operatively.
Secondary outcome [4] 263549 0
Pain Visual Analogue Score.
Patient pain will be assessed using a visual analogue score (VAS), where patients rate their pain on a 100 mm horizontal line, with one end of the line representing no pain and the other end representing severe pain.
Patients will be asked to note their VAS at rest and on movement or coughing.
Timepoint [4] 263549 0
6 hours, 24 hours, and 48 hours post-operatively.
Secondary outcome [5] 263566 0
The patient's Functional Activity Score will be noted. This is a self-assessed score with gradings as follows:
0 = no limitation - activity is unrestricted by pain.
1 = mild limitation - activity is mild to moderately restricted by pain.
2 = severe limitation - the ability to perform the activity is severely limited by pain.
Timepoint [5] 263566 0
6 hours, 24 hours, and 48 hours post-operatively.
Secondary outcome [6] 263567 0
Total morphine use 0-48 hours post-operatively.
Timepoint [6] 263567 0
48 hours post-operatively.

Eligibility
Key inclusion criteria
Patients age 18 years or over.
Elective or semi-elective surgery requiring a mid-line abdominal incision.
Planned intraoperative Transversus Abdominis Plane blocks and postoperative morphine patient controlled analgesia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Plan for epidural and/or spinal analgesia.
Surgeon or anaesthetist refusal to placement of catheters.
Inability to communicate in English due to a language barrier, cognitive deficit or intellectual disability.
Inability of patient to use patient controlled analgesia (PCA) pump postoperatively or to understand visual analogue pain score.
Patients flagged for postoperative ventilation.
Asthma if exacerbated by non-steroidal anti-inflammatory drugs (NSAIDs) or asthma if a patient has never taken a NSAID.
Acute abdomen, with clinical signs of abdominal peritonism.
Septicaemia involving positive bacterial blood cultures.
Localised infection at the site of proposed needle insertion.
Opioid tolerant patients, i.e. any of the following:
-Patient taking an average of 8 Panadeine Forte tablets per day for a greater than one week.
-Patients taking greater than 40 mg oxycodone per day for greater than one week.
-Patients receiving 20 mg morphine parenterally per day for greater than one week.
-Patients on a fentanyl patch of dose greater than 12.5 mcg/hour for greater than one week.
-Any patient receiving buprenorphine.
-Any patient receiving methadone.
-Any patient receiving naltrexone or naloxone as part of an opioid abstinence program.
Any history of injected or inhaled illicit drug use in the previous six months.
A clinical history of chronic pain, where patients may benefit from early commencement of ketamine.
Renal impairment with creatinine clearance less than 60 mL/min.
Severe hepatic impairment (Child-Pugh score greater than or equal to 10).
Patients with unstable or uncontrolled epilepsy.
Allergy or contraindication to morphine, ropivacaine, tramadol, parocoxib, sulphonamides or paracetamol.
Patients on ketaconazole, fluconazole, monoamine oxidase inhibitors, selective serotonin reuptake inhibitors (SSRIs), serotonin noradradrenaline reuptake inhibitors (SNRIs), tricyclic anti-depressents, carbemazepine, quinidine, antipsychotics, zidovudine or warfarin.

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)
Eligible patients to be indentified prior to surgery using surgical lists. They will be approached by research personel to explain trial and obtain consent. Patients will be randomised at the end of surgery to receiving either local anaesthetic or saline infusion. Randomization will be concealed from the investigators and patients as the randomization sequence will be held by the Pharmacy Department. When a patient is recruited, Pharmacy will be contacted and directed to make up the study solution as per the randomization schedule. The log of the bag numbers and the bag contents will be kept by Pharmacy and be available to the Principal Investigator in case of requirement for unblinding. Additionally, a sealed envelope labeled with the patient number will be attached to the infusion bags. This envelope will contain the details of the bags' contents. The envelope will be removed when the study drug comes to theatre, and kept in a locked filing cabinet in the Department of Anaesthesia of the Hospital. This will provide the means for unblinding if Pharmacy is unavailable, for example after hours.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
When a patient is recruited, they will be assigned a unique 5 digit study code. The first digit codes for the hospital; the next three digits represent the patient number for that hospital; and the final digit will be a check digit, being the sum of the previous four digits.

Patients will be randomized from a pre-determined computer-generated list (random number generator with numbers 0-0.499 coding for placebo and 0.5-1.0 coding for treatment). The program will be cycled until equal numbers in each group are obtained. The column of numbers generated will be placed next to the second column of numbers listing the eighty study codes. Randomization will be stratified by centre. Randomization will be concealed from the investigators and patients as the randomization sequence will be held by the Pharmacy Department.
When a patient is recruited, Pharmacy will be contacted and directed to make up the study solution as per the randomization schedule.

The log of the bag numbers and the bag contents will be kept by Pharmacy and be available to the Principal Investigator in case of requirement for unblinding. Additionally, a sealed envelope labeled with the patient number will be attached to the infusion bags. This envelope will contain the details of the bags’ contents. The envelope will be removed when the study drug comes to theatre, and kept in a locked filing cabinet in the Department of Anaesthesia of the Hospital. This will provide the means for unblinding if Pharmacy is unavailable, for example after hours.
Masking / blinding
Blinded (masking 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
Recruiting
Date of first participant enrolment
Anticipated
1/02/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 326 0
3011
Recruitment postcode(s) [2] 2632 0
3051
Recruitment postcode(s) [3] 2633 0
3677
Recruitment postcode(s) [4] 2634 0
3220

Funding & Sponsors
Funding source category [1] 256669 0
Charities/Societies/Foundations
Name [1] 256669 0
Australian Society of Anaesthetists
Country [1] 256669 0
Australia
Primary sponsor type
Hospital
Name
Western Hospital
Address
148 Gordon St
Footscray 3011
VIC
Country
Australia
Secondary sponsor category [1] 255957 0
Charities/Societies/Foundations
Name [1] 255957 0
Australian and New Zealand College of Anaesthetists
Address [1] 255957 0
ANZCA House
630 St Kilda Road
Melbourne 3004
VIC
Country [1] 255957 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4719 0
Melbourne Health Human Research Ethics Committee (HREC)
Ethics committee address [1] 4719 0
Royal Melbourne Hospital
Grattan St
Parkville 3051
VIC
Ethics committee country [1] 4719 0
Australia
Date submitted for ethics approval [1] 4719 0
01/06/2010
Approval date [1] 4719 0
Ethics approval number [1] 4719 0

Summary
Brief summary
To evaluate whether local anaesthetic running via a catheter in the abdominal wall improves analgesia following abdominal surgery
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28190 0
Address 28190 0
Country 28190 0
Phone 28190 0
Fax 28190 0
Email 28190 0
Contact person for public queries
Name 11347 0
Elizabeth Hessian
Address 11347 0
Western Hospital
148 Gordon St
Footscray 3011
VIC
Country 11347 0
Australia
Phone 11347 0
+61 3 8345 6639
Fax 11347 0
+61 3 83456572
Email 11347 0
[email protected]
Contact person for scientific queries
Name 2275 0
Elizabeth Hessian
Address 2275 0
Western Hospital
148 Gordon St
Footscray 3011
VIC
Country 2275 0
Australia
Phone 2275 0
+61 3 8345 6639
Fax 2275 0
+61 3 83456572
Email 2275 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.