Efficacy of a 96hr duration local anaesthesia (l-bupivacaine) infusion using PainBuster device at the incision site compared with saline controls for post-operative pain management against a background of narcotic analgesia, following open or laparoscopic abdominal surgery.

Colorectal surgical patients treated with Chirocaine infusion versus saline at surgical site, and demands/usage of PCA narcotic analgesic and VAS score.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000439448

Enrollment

Registered

2007-08-29

Start date

2007-09-01

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

Interventions

The aim is to test whether continuous local anaesthetic infusion (0.5% l-bupivacaine at 5ml/h for 0-48hr and 2ml/h for 48-96h post-op) using a commercial infiltration device can minimise, or eliminate, the need for narcotic analgesia following abdominal open or laparoscopic surgery. The potential benefits to the patient include earlier mobilisation, minimisation or averting the side-effects from narcotics (a particular issue in elderly patients following abdominal surgery), and shorter length-of

Study design

Allocation

Non-randomised trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

Able to give informed consent ASA Score <4 (ie., level 1, 2 or 3) Normal to mildly elevated biochemical indices of renal and/or hepatic function Mental status of the patient should be considered and included only if in the opinion of the surgeon and other attended medical staff, that the patient is capable of giving informed consent and would be capable of complying with the reasonable instructions to allow the study to progress Smokers are admissible, and other drugs/medicines normally taken, other than those specified below

Exclusion criteria

Pregnancy. ASA Score >4 (ie., level 4, 5) Moderate to severely elevated indices of renal and/or hepatic function, and patients with dementia Taking drugs known to influence l-bupivacaine kinetics (CYP1A2 or CYP3A inhibitor/inducers; fluvoxamine, quinoline antibacterials, “conazole” antifungals) Taking drugs that may affect pain perception [narcotics (including codeine containing preparations), tricyclic antidepressants, chronic pain killers, anti-epileptic drugs also used in pain therapy) Patients receiving epidural anaesthesia Known allergy to l-bupivacaine or fentanyl

Outcome results