Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000148572
Ethics application status
Approved
Date submitted
14/04/2006
Date registered
1/05/2006
Date last updated
1/05/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Epidural Versus Intrathecal Analgesia in Abdominal Surgery - the EVITA study
Scientific title
A randomised trial to compare pain relief after major open abdominal surgery in patients receiving either epidural or intrathecal analgesia
Universal Trial Number (UTN)
Trial acronym
EVITA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain relief and recovery after surgical resection of the stomach, small bowel or colon. 1120 0
Condition category
Condition code
Oral and Gastrointestinal 1197 1197 0 0
Other surgery
Oral and Gastrointestinal 1198 1198 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
continous infusion analgesia for postoperative pain for 3 days by intrathecal infusion of a solution containing midazolam 0.1mg/ml, morphine 10mcg/ml and bupivacaine 0.gmg/ml at 1-2 ml/hour.
Intervention code [1] 984 0
Treatment: Drugs
Comparator / control treatment
continous infusion analgesia for postoperative pain for 3 days by standard epidural technique (bupivacaine 1.25mg/l + fentanyl 2mcg/ml at 6-14 ml/hour).
Control group
Active

Outcomes
Primary outcome [1] 1626 0
Pain scores on coughing on the verbal analog pain scale
Timepoint [1] 1626 0
On day 2 after surgery
Secondary outcome [1] 2912 0
1. Incidence and frequency of side effects (nausea, vomiting, itch, motor block, sedation, hypotension).
Timepoint [1] 2912 0
Postoperative days 1 to 3.
Secondary outcome [2] 2913 0
2. Use of and type of co-analgesics
Timepoint [2] 2913 0
Postoperative days 1 to 3.
Secondary outcome [3] 2914 0
3. Number of rescue top ups
Timepoint [3] 2914 0
Postoperative days 1 to 3.

Eligibility
Key inclusion criteria
1. Elective open colorectal, gastric or small bowel resection surgery. 2. patient willing to have a neuraxial catheter placed as part of the anaesthetic technique.
Minimum age
50 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Use of prescribed opoids or sedatives, postoperative ventilation.

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)
Double blinding. Sealed envelope method.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1311 0
Self funded/Unfunded
Name [1] 1311 0
Country [1] 1311 0
Primary sponsor type
Individual
Name
Dr Michael Duncan
Address
Country
Secondary sponsor category [1] 1158 0
None
Name [1] 1158 0
n/a
Address [1] 1158 0
Country [1] 1158 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2640 0
Southern Health Ethics committee-Wentworth Area Health Service Ethics committee
Ethics committee address [1] 2640 0
Ethics committee country [1] 2640 0
Australia
Date submitted for ethics approval [1] 2640 0
Approval date [1] 2640 0
Ethics approval number [1] 2640 0

Summary
Brief summary
Patients undergoing major abdominal surgery require intensive postoperative pain relief for many days. Good pain relief improves recovery and poor pain relief hinders recovery. The conventional choices of pain relief are powerful intravenous drugs or an epidural infusion of local anaesthetic with some morphine like drug (opioid) added. Despite extensive experience with these two techniques it remain unclear in which patients the epidural technique is indicated. In Southern Health and selected other hospitals in Australia a third technique has been in use for 15 years – a continous spinal infusion of pain relieving drugs using a spinal catheter (the ‘intrathecal technique’) . A recent quality assurance audit at Monash medical centre showed that the intrathecal technique was superior to the other two techniques. Patients receiving this had better pain relief than alternative techniques. Unfortunately this work was an unblinded audit comparing 3 groups of patients among whom major differences existed in surgical length, type of surgery and age. This limits what can be concluded from the results. In the proposed project the intention is to recruit patients aged over 50 that are scheduled for gut surgery into a study comparing epidural and intrathecal analgesia postoperatively. The aim is to improve pain relief and quality of recovery after surgery. Other factors that will be studied include length of stay, need for additional pain relieving drugs and time till oral intake. The participants, assessor and data analyst will be blinded to the treatment groups. The hospital staff will not be blinded.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36133 0
Address 36133 0
Country 36133 0
Phone 36133 0
Fax 36133 0
Email 36133 0
Contact person for public queries
Name 10173 0
Dr Michael Duncan
Address 10173 0
Dept. Anaesthesia
Monash Medical Centre
246 Clayton Rd
Vic 3168
Country 10173 0
Australia
Phone 10173 0
0395943283
Fax 10173 0
0395946290
Email 10173 0
[email protected]
Contact person for scientific queries
Name 1101 0
Dr Michael Duncan
Address 1101 0
Monash Medical Centre
246 Clayton Rd
Vic 3168
Country 1101 0
Australia
Phone 1101 0
0395943283
Fax 1101 0
0395946290
Email 1101 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

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