A comparison of plasma levobupivacaine concentrations following thoracic epidural analgesia (TEA) and subpleural analgesia (SPA).

A comparison of plasma levobupivacaine concentrations following thoracic epidural analgesia and intrapleural analgesia - a comparison of pharmacokinetics of levobupivacaine, analgesic effectiveness and complication rate in pacient undergoing thoracotomy.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616001541493

Enrollment

Registered

2016-11-08

Start date

2017-05-01

Completion date

2018-02-01

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

A comparison ot two groups with either TEA or IPA after thoracotomy. The aim of the prospective study is to compare a blood concentrations of levobupivacaine 30, 60 and 120 minutes after an injection. Futher, possible side effects of levobupivacaine as well as analgesic effectivness (VAS, AM-PAC score) will be monitored and related to measured blood levobupivacaine concentrations.

Interventions

1. Thoracotomy - diagnostic or therapeutic.anterolateral thoracotomy. 2. Introduction of either thoracic epidural analgesia (TEA) or subpleural (SPA) - epidural or subpleural cathether insertion. TEA group. Insertion of epidural catheter prior surgery using midline or paramedian approach ( level Th2-Th7 depending on surgical procedure). Surgery under general anaesthesia. Immediatelly after thoracotomy closure, bolus of 0,25% 0,25ml/kg levobupivacaine (Chirocaine, AbbVie Ltd., Wanwall, UK) will be given into the epi-catheter. SPA group. Surgery under general anaesthesia (the same type as in TEA group). Insertion of Subpleural cathether placement subpleuraly into paravertebral space before thoracotomy closure under direct visual control of a surgeon. Immediatelly after thoracotomy closure, bolus of 0,25% 0,25ml/kg levobupivacaine (Chirocaine, AbbVie Ltd., Wanwall, UK) will be given into the subpleural catheter.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. elective surgery (thoracotomy) 2. ASA status I-IV

Exclusion criteria

1. Age < 18 years 2. Acute or emergent surgery 3. Contraindication of both TEA and IPA method 4. Refusal of both TEA and IPA by a patient. 5. Chronic pain prior to surgery. 6. Known allergy to painkillers.

Outcome results