None listed
Conditions
Brief summary
This is a pilot study to consider whether post-operative pain management (following right hemicolectomy surgery using a lateral transverse incision) with continuous ropivacaine infusion using an elastomeric infusion pump (ON-Q Painbusterÿ¿??ÿ¿?ÿ¿ÿ®) for 96hr (rather than epidural) is safe, based on the margin between steady-state plasma ropivacaine concentrations attained (in particular, the unbound concentrations) and the systemic toxicity threshold(s). Whilst this device and local anaesthetic approach are currently used for post-op pain management, common usage in Australia is currently limited to 48-hr post-op.
Interventions
Pain management with local anaesthetic (ropivacaine) continuous infusion during- & post-op using ON-Q pain Buster device.
Sponsors
TQEH Research Foundation
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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 functionMental 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 progressSmokers are admissible, and other drugs/medicines normally taken, other than those specified below. Patient with no previous abdominal surgery.
Exclusion criteria
Failure to provide written informed consentUnder 18 years of agePregnancy. Clearly pregnant females with bowel cancer would be a complication requiring specific clinical management, and so not appropriate for this pilot studyASA Score >4 (ie., level 4, 5)Moderate to severely elevated indices of renal and/or hepatic function, and patients with dementiaTaking drugs known to influence ropivacaine 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, regular non-steroidal use including COX-2 inhibitors, chronic pain killers, anti-epileptic drugs also used in pain therapy)Larger tumor size (>8cm)Previous abdominal surgery, including laparotomyKnown allergy to ropivacaine or fentanyl.
Outcome results
None listed