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.

Not Applicable

Completed

• Conditions: Post-operative pain management; Surgery - Other surgery

• Registration Number: ACTRN12607000439448
• Lead Sponsor: The Queen Elizabeth Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-08-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified