A randomised trial to compare post-operative respiratory function following bolus abdominal block local anaesthesia, versus standard infusional abdominal block local anaesthesia in patients undergoing gastrointestinal resectional surgery

Phase 3

Completed

• Conditions: Gastrointestinal resectional surgery; Anaesthesiology - Pain management; Surgery - Other surgery

• Registration Number: ACTRN12613000380796
• Lead Sponsor: Hunter New England Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

All patients undergoing elective or semi-urgent booked abdominal gastrointestinal resectional surgery at the following institutions:
- John Hunter Hospital
- Newcastle Private Hospital
- Belmont District Hospital
- The Calvary Mater Newcastle
- Lake Macquarie Private Hospital
- The Maitland Hospital
- Maitland Private Hospital

Exclusion Criteria

- Refusal or unable to give written, informed consent to participate in the study, or
- Patient has received an epidural, spinal or other neuroaxial anaesthetic
- Patient is under 18 years of age, or
- Patient receives an operation that involves extra incisions outside the abdominal wall (such as abdomino-perineal resections), or
- Patient has a known allergy or adverse drug reaction to local anaesthetic agents or morphine or fentanyl, or
- Patient has a history of arrhythmia or long QT syndrome associated with the drugs used in this trial, or
- Patient remains intubated post procedure
- Patient is taking regular opiate narcotics pre-operatively

Patients will be withdrawn from the trial if: - At any time they wish to discontinue with the trial, or Post-operative complications within the first 72 hours result in the patient being unable to be assessed for study outcomes (e.g. requiring post-operative ventilation)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The difference between baseline pre-operative and post-operative forced expiratory volume in first second (FEV1), forced vital capacity (FVC) and peak expiratory flow (PEF) as measured by hand-held spirometer.<br><br>[Pre-operative baseline and post-operative days 1, 2 and 3]