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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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12606000148572
Acronym
EVITA
Enrollment
100
Registered
2006-05-01
Start date
2006-08-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

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.

Sponsors

Dr Michael Duncan
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No

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.

Exclusion criteria

Use of prescribed opoids or sedatives, postoperative ventilation.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026