Thoracotomy: Intercostal Nerve Block Versus Epidural Anesthesia

Study Overview
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Brief Summary
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Postoperative pain and consecutive reduction of pulmonary function after thoracic surgery still is a major clinical problem and challenge in anesthesia. Thoracic epidural anesthesia is commonly considered to be the gold standard for postoperative pain control and restoration of pulmonary function after thoracic surgery. Thus, the aim of the present study is to investigate whether an intercostal nerve block with ropivacaine plus intravenous PCA with morphine is as effective as thoracic epidural anesthesia with respect to postoperative pain control and pulmonary

Official Title
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Analgesia and Pulmonary Function After Thoracic Surgery: is an Intercostal Nerve Block Plus Intravenous Morphine as Effective as Epidural Anesthesia? A Prospective Randomized Clinical Study.

Conditions
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Thoracotomy

Intervention / Treatment
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* Procedure: epidural anesthesia
* Procedure: intercostal anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing elective pulmonary surgery, including pneumonectomy, bilobectomy, lobectomy, typical and atypical segmentectomy, via a lateral or posterolateral thoracotomy without chest-wall resection Exclusion Criteria: age<18 yr any contraindication to epidural anaesthesia, intercostal nerve block or the use of ropivacaine, morphine, metamizol or diclofenac lack of patient's cooperation any type of chronic painful condition or current opioid use

Ages Eligible for Study
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Minimum Age: 18 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: epidural anesthesia<br> | Procedure: epidural anesthesia<br>* In the epidural group prior to the induction of general anesthesia, a thoracic epidural catheter will be was placed at the level of the TH6-TH8. 8 ml ropivacaine 1% were administered through the epidural catheter. EDA is aimed at a sensory block level from TH2 to TH10.<br>|
| Active Comparator: intercostal anesthesia<br> | Procedure: intercostal anesthesia<br>* In the intercostal group, before chest closure, each 4 ml ropivacaine 0.75 % will be injected by the surgeon under direct vision into the proximal intercostal space at the level of the thoracotomy and two spaces above and below as well as 5 ml ropivacaine 0,75 % at the thoracic drainage tube exits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at rest and on coughing after thoracic surgery |  | Pain during the first four postoperative days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulmonary function (peak expiratory flow rate) after thoracic surgery |  | first four postoperative days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, thoracotomy, pulmonary function, epidural anesthesia, intercostal nerve block