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Thoracic epidural analgesia (TEA) is the basic method of analgesia in patients undergoing pulmonary lobectomy. TEA is considered to be a safe and thoroughly investigated method of pain relief that rarely causes serious complications. However, blocking the nerves as they emerge from the spinal column (paravertebral block, PVB) may represent an alternative method with some potential benefits. In this study, TEA and PVB will be compared for patients undergoing pulmonary lobectomy by video assisted thoracoscopic surgery. The aim of the study is to test the hypothesis, that PVB is a time-saving procedure compared with TEA on the day of surgery and that PVB is as efficient in postoperative pain reduction as TEA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thoracic epidural analgesia | Active Comparator | Standard thoracic epidurals preoperatively at the dag of surgery. |
|
| Paravertebral block | Experimental | Paravertebral block inserted at the end of the operation by the surgeons |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thoracic epidural | Drug | Standard thoracic epidural (needle inserted into the space between the covering of spinal cord and the cord itself) preoperatively. Standard thoracic epidural analgesia mixture (2 mg/ ml bupivacaine, 2 µg/ ml fentanyl and 2 µg/ ml adrenalin) with an infusion of 6-10 ml/hour until day 2 postoperatively. Thereafter reduction by 30 % every four hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Time in minutes total time at the operating ward | 1 hour | |
| Pain intensity during hospitalization: Numerical Rating Scale (NRS) | using the Numerical Rating Scale (NRS) in predetermined time intervals after the operation | Up to 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital length of stay in days | until discharge from hospital (max 1 month) |
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Inclusion Criteria:
Patients with lung cancer in stage 1 or 2 who are accepted for VATS-lobectomy
Exclusion Criteria, preoperative:
Patients who do not wish to participate
Patients with:
Exclusion Criteria, Per- and postoperative
Patients who wish to withdraw from the study
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Wahba, md phd | St. Olavs Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Olavs Hospital | Trondheim | Norway |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D013662 | Tea |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
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|
| Paravertebral block | Drug | Paravertebral block containing 5 ml bupivacaine 5 mg/ ml (optionally 10 ml bupivacaine 2,5 mg/ ml). In addition per-oral painkillers (oxycodone and paracetamol) from the day of surgery. |
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |