Not Yet RecruitingPhase 2ACTRN12606000148572

Epidural Versus Intrathecal Analgesia in Abdominal Surgery - the EVITA study

A randomised trial to compare pain relief after major open abdominal surgery in patients receiving either epidural or intrathecal analgesia


Sponsor

Dr Michael Duncan

Enrollment

100 participants

Start Date

Aug 1, 2006

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying: Epidural Versus Intrathecal Analgesia in Abdominal Surgery - the EVITA study. It may be open to adults aged 50 and older. Participation typically involves medical assessments, possible treatment with the study intervention, and follow-up visits to track your health.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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.

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.


Locations(1)

Australia

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ACTRN12606000148572