ANZCTR - Registration

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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.

Condition category

Condition code

Oral and Gastrointestinal

Other surgery

Oral and Gastrointestinal

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]

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]

Pain scores on coughing on the verbal analog pain scale

Timepoint [1]

On day 2 after surgery

Secondary outcome [1]

1. Incidence and frequency of side effects (nausea, vomiting, itch, motor block, sedation, hypotension).

Timepoint [1]

Postoperative days 1 to 3.

Secondary outcome [2]

2. Use of and type of co-analgesics

Timepoint [2]

Postoperative days 1 to 3.

Secondary outcome [3]

3. Number of rescue top ups

Timepoint [3]

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?

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]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Individual

Name

Dr Michael Duncan

Address

Country

Secondary sponsor category [1]

None

Name [1]

n/a

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Health Ethics committee-Wentworth Area Health Service Ethics committee

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Michael Duncan

Address

Dept. Anaesthesia Monash Medical Centre 246 Clayton Rd Vic 3168

Country

Australia

Phone

0395943283

Fax

0395946290

[email protected]

Contact person for scientific queries

Name

Dr Michael Duncan

Address

Monash Medical Centre 246 Clayton Rd Vic 3168

Country

Australia

Phone

0395943283

Fax

0395946290

[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.

Trial Review

Documents added manually

Documents added automatically