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

Phase 3

Completed

• Conditions: Bowel Cancer Surgery; Cancer - Bowel - Anal; Cancer - Bowel - Back passage (rectum) or large bowel (colon); Cancer - Bowel - Small bowel (duodenum and ileum; Anaesthesiology - Pain management; Surgery - Other surgery

• Registration Number: ACTRN12605000413628
• Lead Sponsor: TQEH Research Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of LA[serial blood sampling 0-96hr of local anaesthetic administration]

Secondary Outcome Measures

Name	Time	Method
Efficacy (measured by 12hrly pain scores using Visual Analogue Scales; and also by frequency of using Patient Controlled Analgesia with narcotic).[Over the 4-5 days of the admission.];Infection rate (scored by the appearance, duration, organism, and treatment of infection at the surgical site).[During the 4-day treatment with the PainBuster.]