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

A Randomised Trial to compare post-operative respiratory function in patients receiving bolus abdominal block local anaesthesia, to patients receiving the standard infusional abdominal block local anaesthesia in patients undergoing gastrointestinal resectional surgery

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000380796

Acronym

ABBI Study (Abdominal Block Bolus Infusion Study)

Enrollment

120

Registered

2013-04-09

Start date

2013-04-09

Completion date

2014-06-13

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The study is trying to find out which is the best way to deliver a medication for pain relief called a local anaesthetic (a drug that helps to numb areas of the body e.g. the skin) to the abdominal wall in patients undergoing major abdominal surgery in order to help reduce the post-operative pain.

Interventions

Arm B is intervention: abdominal wall block by bolus administration of the local anaesthetic agent ropivacaine 0.2% every 6 hours until block is removed. Boluses are 20mls of 0.2% ropivacaine through each catheter for bilateral catheters, and 40mls of 0.2% ropivacaine for unilateral catheters. A maximum dose of 0.2% ropivacaine for intervention arm is 3mg/kg for each bolus dose.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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)

Outcome results