New Truncal Nerve Blocks for Thoracoscopic Surgery and Open Heart Surgery.
NCT ID: NCT03704753
Last Updated: 2023-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
200 participants
INTERVENTIONAL
2019-01-25
2025-05-31
Brief Summary
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Detailed Description
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In this sub-study 120 patients will be randomly assigned to one of four groups:
SAPB group A 30ml of Ropivacaine 7,5mg/ml is injected above m. serratus anterior after thoracoscopic lung surgery. Injection is done under ultrasound guidance.
SAPB group B 30ml of Sodiumchloride 0.9 is injected above m. serratus anterior after thoracoscopic lung surgery. Injection is done under ultrasound guidance.
SAPB group C 30ml of Ropivacaine 7,5mg/m is injected above m. serratus anterior after thoracoscopic lung surgery. Also a multi-holed catheter is left in place. Through catheter 20ml Ropivacaine 2mg/ml is injected every 12 hours after surgery.
SAPB group D A multi-holed catheter is placed in single intercostal space under thoracoscopic visualization. 20ml of Ropivacaine 7,5mg/ml is injected after application of the catheter, also a continuous infusion of ropivacaine 2mg/ml is started. Rate of the infusion is determined by patients weight.
Subpectoral Interfascial Plane block (SIP) - sub-study
In this sub-study 80 patients will be randomly assigned to one of two groups:
SIP group A 20ml of ropivacaine 7,5mg/ml is injected under both pectoralis major muscles before medial sternotomy. Injection is done under ultrasound guidance.
SIP group B 20ml of sodiumchloride 0.9 is injected under both pectoralis major muscles before medial sternotomy. Injection is done under ultrasound guidance.
Every patients postoperative pain is treated with intravenous oxycodone PCA-pump.
The investigators will evaluate post operative pain based on the Numeric rating Scale, 24 hours oxycodone consumption. The investigators will also evaluate post operative chronic pain using three questionnaires: EQ5D, STAIT-TRAIT and Pain Detect. In SAPB sub-study the questionnaires are done three weeks and 6 months post. operatively. In SIP sub-study the questionnaires are done 6 months and 12 months post.operatively.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SAPB group A
SAPB single injection. 30ml of Ropivacaine 7,5mg/ml is injected above m. serratus anterior after thoracoscopic lung surgery. Infection is done under ultrasound guidance.
Ropivacaine
Serratus anterior plane block for thoracic surgery patients and subpectoral interfascial nerve block for open heart surgery patients
SAPB group B
SAPB single injection (placebo). 30ml of SodiumChloride 0.9 is injected above m. serratus anterior after thoracoscopic lung surgery. Infection is done under ultrasound guidance.
Sodium chloride 0.9%
Serratus anterior plane block for thoracic surgery patients and subpectoral interfascial nerve block for open heart surgery patients (placebo).
SAPB group C
SAPB single injection and catheter. 30ml of Ropivacaine 7,5mg/ml is injected above m. serratus anterior after thoracoscopic lung surgery and a multi-holed catheter is left in place. 20ml of Ropivacaine 2mg/ml is injected every 12h through catheter postoperatively.
Ropivacaine
Serratus anterior plane block for thoracic surgery patients and subpectoral interfascial nerve block for open heart surgery patients
SAPB group D
Continious intercostal catheter. 20ml of Ropivacaine 7,5mg/ml is injected through intercostal catheter, which i placed under thoracoscopic visualization. After single injection a continuous infusion of Ropivacaine 2mg/ml is started (weight dependent daily dosage).
Ropivacaine
Serratus anterior plane block for thoracic surgery patients and subpectoral interfascial nerve block for open heart surgery patients
SIP group A
SIP single injection 20ml of Ropivacaine 7,5mg/ml is injected under pectoralis major muscle on both sides of sternum. Injection is done under ultrasound guidance.
Ropivacaine
Serratus anterior plane block for thoracic surgery patients and subpectoral interfascial nerve block for open heart surgery patients
SIP group B
SIP single injection (placebo) 20ml of SodiumChloride 0.9 is injected under pectoralis major muscle on both sides of sternum. Injection is done under ultrasound guidance.
Sodium chloride 0.9%
Serratus anterior plane block for thoracic surgery patients and subpectoral interfascial nerve block for open heart surgery patients (placebo).
Interventions
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Ropivacaine
Serratus anterior plane block for thoracic surgery patients and subpectoral interfascial nerve block for open heart surgery patients
Sodium chloride 0.9%
Serratus anterior plane block for thoracic surgery patients and subpectoral interfascial nerve block for open heart surgery patients (placebo).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
85 Years
ALL
No
Sponsors
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Tampere University Hospital
OTHER
Responsible Party
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Locations
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Tampere Heart Hospital
Tampere, , Finland
Countries
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Central Contacts
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Facility Contacts
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References
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Kalli A, Vistbacka J, Moilanen E, Jarvela K, Mennander A. Superficial Parasternal Intercostal Plane Block and Full Sternotomy; A Randomized Trial. Eur J Cardiothorac Surg. 2025 Jul 1;67(7):ezaf226. doi: 10.1093/ejcts/ezaf226.
Other Identifiers
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R18011M
Identifier Type: -
Identifier Source: org_study_id
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