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

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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001626257
Acronym
COBALT
Enrollment
48
Registered
2018-10-03
Start date
2019-02-11
Completion date
2023-07-27
Last updated
2025-09-08

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

Conditions

None listed

Brief 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.

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

Sponsors

Austin Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026