TerminatedPhase 4ACTRN12618001626257

COntinuous or Bolus Administration of Local Anaesthesia for Thoracic Surgery : a single blinded randomized trial (COBALT Trial)


Sponsor

Austin Hospital

Enrollment

120 participants

Start Date

Feb 11, 2019

Study Type

Interventional

Conditions

Summary

Our study will examine if the use of intermittent boluses improves pain and decreases opioid use when compared to continuous infusions when delivered through an exrtrapleural catheter in patients undergoing thoracoscopic surgery (VATS), a form of lung surgery. We will also investigate whether lung function is improved in the post-operative period. Design: Randomised single centre blinded clinical trial. Both groups will receive the same overall dose of ropivacaine.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

  • Patients undergoing Video-assisted thoracic surgery (VATS)

Exclusion Criteria15

  • Age less than 18 years
  • Indication for operation is Pleurodesis
  • Contraindications or allergy to oxycodone or ropivacaine
  • Failure of, or contraindication to surgical placement of an extrapleural catheter intraoperatively as assessed by thoracic surgeon.
  • Pre-operative regular opioid use (>60 OMEDD)
  • Other recent injuries or surgeries causing significant pain
  • Weight >100kg
  • Pre-operative coagulopathy: INR > 1.5, platelet count < 75 x 109/l
  • Severe renal impairment: serum creatinine > 200ummol/l
  • Severe hepatic insufficiency (bilirubin > 30umol/L, ALP > 300iu/L, ALT > 50iu/L, albumin < 25g/dL, INR > 1.5)
  • American Society of Anesthesiologists (ASA) physical status IV or V
  • Currently pregnant
  • Cognitive impairment or intellectual disability precluding informed consent or satisfactory participation in the study
  • Unable to speak English sufficiently to enable informed consent or understand instructions.
  • Previous enrolment into our study

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Interventions

0.2% Ropivacaine at 0.15 ml/kg given every hour via Programmed intermittent boluses through a paravertebral catheter for three days post-operatively

0.2% Ropivacaine at 0.15 ml/kg given every hour via Programmed intermittent boluses through a paravertebral catheter for three days post-operatively


Locations(1)

Austin Health - Austin Hospital - Heidelberg

VIC, Australia

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ACTRN12618001626257


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