Paravertebral Block Versus Thoracic Epidural Analgesia

Study Overview
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Brief Summary
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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.

Official Title
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Paravertebral Block Versus Thoracic Epidural Analgesia in Patients Undergoing Video Assisted Lung Surgery

Conditions
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Lung Cancer, Postoperative Pain

Intervention / Treatment
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* Drug: Thoracic epidural
* Drug: Paravertebral block


Participation Criteria
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Eligibility Criteria
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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: suspicion of ingrowth in the thoracic wall. marginal lung function. kidney failure. chronic pains and/ or daily use of opioids. cognitive, visual and / or linguistic dysfunction. allergies to drugs used in the paravertebral block or the thoracic epidural analgesia. Exclusion Criteria, Per- and postoperative conversion from VATS to thoractomy. unsuccessful admission of thoracic epidural analgesia unsuccessful admission of paravertebral block postoperative respiratory treatment postoperative delirium Patients who for various reasons are not able to self-report pain after surgery. Patients who wish to withdraw from the study

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Thoracic epidural analgesia<br>Standard thoracic epidurals preoperatively at the dag of surgery. | Drug: Thoracic epidural<br>* 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.<br>|
| Experimental: Paravertebral block<br>Paravertebral block inserted at the end of the operation by the surgeons | Drug: Paravertebral block<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay in days |  | until discharge from hospital (max 1 month) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumonectomy, Epidural analgesia