New Truncal Nerve Blocks for Thoracoscopic Surgery & Open Heart Surgery.

Status Recruiting

Clinical Trial Summary

This study is divided to two sub-studies. First sub-study evaluates if Serratus Anterior Plane block (SAPB) reduces opioid consumption after thoracoscopic surgery. Secondly continuous SAPB is compared to continuous intercostal blockade. Second sub-study evaluates if Subpectoral Interfascial Plane block (SIP) reduces opioid consumption after medial sternotomy.

Clinical Trial Description

Serratus anterior plane block (SAPB) - sub-study 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03704753
Study type	Interventional
Source	Tampere University Hospital
Contact	Antti J Kalli, MD
Phone	0500723498
Email	antti.kalli@sydansairaala.fi
Status	Recruiting
Phase	Phase 4
Start date	January 25, 2019
Completion date	May 31, 2025

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

New Truncal Nerve Blocks for Thoracoscopic Surgery and Open Heart Surgery.

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms