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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: Sodium chloride 0.9%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective thoracoscopic lung surgery or elective open heart valve surgery Exclusion Criteria: DM1 with complications, lack of co-operation, refusal, chronic pain, chronic intake of opioids or use of SNRI or tricyclic antidepressants.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised and double blinded.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SAPB group A<br>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. | Drug: Ropivacaine<br>* Serratus anterior plane block for thoracic surgery patients and subpectoral interfascial nerve block for open heart surgery patients<br>|
| Placebo Comparator: SAPB group B<br>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. | Drug: Sodium chloride 0.9%<br>* Serratus anterior plane block for thoracic surgery patients and subpectoral interfascial nerve block for open heart surgery patients (placebo).<br>|
| Active Comparator: SAPB group C<br>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. | Drug: Ropivacaine<br>* Serratus anterior plane block for thoracic surgery patients and subpectoral interfascial nerve block for open heart surgery patients<br>|
| Active Comparator: SAPB group D<br>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). | Drug: Ropivacaine<br>* Serratus anterior plane block for thoracic surgery patients and subpectoral interfascial nerve block for open heart surgery patients<br>|
| Active Comparator: SIP group A<br>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. | Drug: Ropivacaine<br>* Serratus anterior plane block for thoracic surgery patients and subpectoral interfascial nerve block for open heart surgery patients<br>|
| Placebo Comparator: SIP group B<br>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. | Drug: Sodium chloride 0.9%<br>* Serratus anterior plane block for thoracic surgery patients and subpectoral interfascial nerve block for open heart surgery patients (placebo).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption | Oxycodone | 24 postoperative hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Surgery, Thoracic Surgery, Nerve block