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Thoracic surgery correlates with significant pain in postoperative period. In order to alleviate the pain various combinations of pharmaceuticals and administration methods are employed. So as to reduce the extent of surgical trauma and, consequently, correlated pain various operation techniques are used. In traditional thoracotomy epidural anesthesia remains a golden standard. Epidural anesthesia however demands high skills to be performed correctly and presents an increased risk of grave complications. In videothoracoscopic (VATS) operations paravertebral blockade can be employed, yet there is no certainty if its efficacy after lung lobectomy. We therefore designed a prospective, randomized, parallel group, single site study to test the hypothesis, that continuous paravertebral blockade is as efficient in postoperative pain reduction as continuous epidural blockade and possesses a higher safety profile.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Thoracic Paravertebral Block | Experimental |
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| Continuous Thoracic Epidural Analgesia | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Thoracic Epidural Block | Procedure | Before anesthesia, continuous thoracic epidural block of T5/T6 is performed (Portex Epidural Minipack set). Identification of paravertebral space by loss of resistance technique (air). A catheter is advanced ca. 3-5 cm, and test dose with 2 ml of lidocaine 2% i injected. At the end of surgery syringe with 0,25% bupivacaine with epinephrine 1:200.000 is connected to catheter and 6 ml bolus is injected, followed by an infusion of the same mixture at 0,06 ml/kg/h for postoperative pain management. |
| Measure | Description | Time Frame |
|---|---|---|
| pain intensity measured in VAS in predetermined time intervals after the operation | up to 96 hrs after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| respiratory parameters indirectly indicating conditions for efficient cough: peak expiratory flow (PEF), forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) | up to 96 hrs after the surgery | |
| frequency of side effects of regional anesthesia: urine retention resulting in necessity of bladder catheterization, hypotension, respiratory depression |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Hospital | Zakopane | 34-500 | Poland |
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| Continuous Thoracic Paravertebral Block | Procedure | Before anesthesia, continuous thoracic paravertebral block of T5/T6 is performed (Portex Epidural Minipack set). Identification of paravertebral space by loss of resistance technique (normal saline). After injection of 5-10 ml of normal saline a catheter is advanced medially ca. 5 cm. At the end of surgery syringe with 0,25% bupivacaine with epinephrine 1:200.000 is connected to catheter and 20 ml bolus is injected, followed by an infusion of the same mixture at 0,08 ml/kg/h for postoperative pain management |
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| Patient-Controlled Analgesia with Morphine | Procedure | Once arrived at the PACU all patients are placed on a postoperative analgesia regimen, that include:
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| up to 96 hrs after surgery |
| frequency of respiratory complications: atelectasis or pneumonia | up to 96 hrs after surgery |
| cumulative opioid (morphine) consumption | up to 96 hrs after surgery |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D016058 | Analgesia, Patient-Controlled |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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