Thoracic Paravertebral Blocks in Open Nephrectomy

Study Overview
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Brief Summary
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60 patients ASA I-III, undergoing open nephrectomy will be randomly assigned into one of two groups, namely group A (n=30), where a thoracic paravertebral block will be performed preoperatively and a paravertebral catheter for continuous and patient controlled bolus local anesthetic (ropivacaine) doses will be inserted and group B (n=30) where morphine IV will be administered at the beginning and the end of operation and postoperatively through patient controlled IV doses. NRS scores in static and dynamic conditions, complications, patient satisfaction, oxidative stress (through lactic acid, superoxide dismutase, malondialdehyde) and NGAL pre- and postoperatively, will be recorded.

Official Title
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Thoracic Paravertebral Blocks in Open Nephrectomy. A Prospective, Randomized Study of Block Efficacy and Influence on Oxidative Stress and Patient Outcome.

Conditions
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Nephrectomy, Analgesia

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: Morphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physical status according to American Society of Anesthesiologists (ASA) I-III Patients scheduled for open nephrectomy Exclusion Criteria: Previous operation on same kidney Contraindication of paravertebral block or any of the agents used in the protocol BMI above 32 Any concurrent malignancy not cured Serious psychiatric, mental and cognitive disorders Block failure Chronic pain Severe kidney disfunction

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 80 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Thoracic paravertebral block using ropivacaine | Drug: Ropivacaine<br>* Paravertebral block using ropivacaine preoperatively and postoperatively<br>|
| Active Comparator: Group B<br>Morphine IV | Drug: Morphine<br>* Morphine intraoperatively and postoperatively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever) | 48 hours | 
| Oxidative stress - lactic acid (mmol/L) |  | 24 hours | 
| Oxidative stress - superoxide dismutase (units/ml) |  | 24 hours | 
| Oxidative stress - malondialdehyde (nmol/mg protein) |  | 24 hours | 
| Oxidative stress - neutrophil gelatinase-associated lipocalin (NGAL) (ng/ml) |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications |  | 48 hours | 
| Patient satisfaction | Patients asked whether they would choose the same anaesthetic management in a future operation: Yes/No | 48 hours | 
| Patient mobilization | Patient reporting time of first standing to the side of the bed | 7 days | 
| Intestinal function | Time of first passing of rectal gas, reported by the patient | 7 days | 
| Chronic pain | Using of Graded Chronic Pain Scale (GCPS) Grade 0: No pain in prior 6 months Grade 1: Low Intensity - Low Disability Grade II: High Intensity Characteristic Pain Intensity - Low Disability Grade III: High Disability - Moderately Limiting Grade IV: High Disability - Severely Limiting | 6 months |