CompletedPhase 3ACTRN12613000380796

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


Sponsor

Hunter New England Local Health District

Enrollment

120 participants

Start Date

Apr 9, 2013

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria8

  • 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 Criteria9

  • 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  • Patients will be withdrawn from the trial if: - At any time they wish to discontinue with the trial, or Post-operative complications within the first 72 hours result in the patient being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)

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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

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.


Locations(7)

Belmont Hospital - Belmont

NSW, Australia

The Maitland Hospital - Maitland

NSW, Australia

Calvary Mater Newcastle - Waratah

NSW, Australia

Newcastle Private Hospital - New Lambton Heights

NSW, Australia

Lake Macquarie Private Hospital - Gateshead

NSW, Australia

Maitland Private Hospital - East Maitland

NSW, Australia

John Hunter Hospital Royal Newcastle Centre - New Lambton

NSW, Australia

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ACTRN12613000380796