CompletedPhase 3Phase 4ACTRN12605000413628

A preliminary safety study comparing the concentration of a local anaesthetic absorbed into the blood (when trickling near the surgical site for 96hours after surgery) to published threshold for toxicity

Pilot study investigating the safety & efficacy of 96hr duration local anaesthesia (ropivacaine) infused at the incision site for post-operative pain management following right hemicolectomy


Sponsor

TQEH Research Foundation

Enrollment

10 participants

Start Date

Jan 2, 2005

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying A preliminary safety study comparing the concentration of a local anaesthetic absorbed into the blood (when trickling near the surgical site for 96hours after surgery) to published threshold for toxicity. It may be open to adults aged 18 and older. Participation typically involves regular medical visits, tests, and following the study's treatment plan.

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

Pain management with local anaesthetic (ropivacaine) continuous infusion during- & post-op using ON-Q pain Buster device.

Pain management with local anaesthetic (ropivacaine) continuous infusion during- & post-op using ON-Q pain Buster device.


Locations(1)

Australia

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ACTRN12605000413628