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

Phase 4

Recruiting

• Conditions: Thoracic Surgery; Pain Management; Anaesthesiology - Pain management

• Registration Number: ACTRN12618001626257
• Lead Sponsor: Austin Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-03
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

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

Inclusion Criteria

Patients undergoing Video-assisted thoracic surgery (VATS)

Exclusion Criteria

-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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oxycodone consumption on day 1. This will be taken from the CADD-Solis pump which tracks PCA usage.. Electronic medical records will be checked for administration of other opiates (off protocol) and this will be converted to iv oxycodone equivalents as per ANZCA opioid calculator app v1.0 and added together.[Day 1 post surgery. From 8:00 am to 8:00 am]

Secondary Outcome Measures

Name	Time	Method
Oxycodone consumption on day 1. This will be taken from the CADD-Solis pump which tracks PCA usage.. Electronic medical records will be checked for administration of other opiates (off protocol) and this will be converted to iv oxycodone equivalents as per ANZCA opioid calculator app v1.0 and added together.[Day 2 and 3 post-operatively<br>Cumulative 72 hour dose. postoperatively];NRS Pain scores[Days 1 2 and 3 postoperatively];Respiratory Function tests performed by hand-held spirometry. Looking at % change in FEV1 from baseline. [Day 1 2 and 3 post-operatively];Length of stay, taken from medical records electronic database and calculated from the time of completion of surgery to hospital discharge.[Hospital stay];Persistent post surgical pain as measured by the Brief Pain Inventory short form[3 months post- surgery (+/- 7 days) ];Respiratory Function tests performed by hand-held spirometry. Looking at % change in FVC from baseline. [Day 1 2 and 3 post-operatively]