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

TQEH Research Foundation0 sites10 target enrollmentSeptember 15, 2005

Overview

No summary available.

Registry

who.int

Start Date

September 15, 2005

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

TQEH Research Foundation

•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.

•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.