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Continuous Local Anaesthetic Wound Infiltration in Hepatobiliary Surgery - A Comparison with Placebo

In hepatobiliary surgical patients, does the use of continuous local anaesthetic wound infiltration compared with placebo wound infiltration improve patient outcomes in terms of better analgesia, reduced opiate consumption and reduced opiate side effects

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000832077
Enrollment
80
Registered
2010-10-05
Start date
2010-11-01
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

The aim of this project is to see whether continuous local anaesthetic wound infiltration for 48 hours post-operatively is useful in hepatobiliary surgical procedures in terms of: 1. Better pain relief 2. Reduced opiate consumption via patient-controlled analgesia (PCA) regime 3. Reduced opiate side effects (eg. nausea and vomiting, sedation, itch) All patients enrolled would have a continuous wound infiltration catheter with a local anaesthetic pump device attached, as well as an opioid-continaing PCA machine. The contents of this pump device would be randomised to contain either local anaesthetic agent or normal saline (placebo). The wound infiltration catheter and infusion pump would remain for 48 hours post-operatively, and the PCA would remain available to each patient as long as clinically required. Each patient would be reviewed post-operatively as per our normal Acute Pain Service (APS) practice, and each patient would have regular observations performed and recorded as per normal protocol. The data collected from each patient would include total opioid requirement via PCA, visual analogue scale (VAS) pain scores both at rest and with movement, and any side effects possibly related to local anaesthetic agents or infusion pump catheters.

Interventions

Painbuster' wound infiltration device infusing local anaesthetic agent (0.2% Ropivacaine at rate of 4ml / hour) into surgical wounds for a 48 hour period post-operatively

Sponsors

Dr Lauren Radford
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. Undergoing elective open hepatobiliary surgical procedure 2. American Society of Anaesthesiologists (ASA) physical status I, II or III 3. Physically and mentally able to use patient-controlled analgesia (PCA) machine

Exclusion criteria

1. Contraindication or known allergy to local anaesthetic drug 2. Preoperative cognitive dysfunction 3. Preoperative diagnosis of chronic pain or opiate tolerance

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026