Post-operative Pulmonary Function After Kidney Surgery Under Two Different Techniques

Study Overview
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Brief Summary
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To assess the respiratory and analgesic effects of continuous thoracic paravertebral block versus thoracic epidural in patients undergoing kidney surgery

Detailed Description
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Study tools An Ultrasound machine (Madison X6) with superficial linear and curved probe. A 19 gauge echogenic needle and Plexolong Cather (PAJUNK, Plexolong Meier nanoline, Geisingen, Germany; 60 mm). A 17-gauge Tuohy needle and 19 G flex-tip catheter: for thoracic epidural. Spirometer: (Enraf-Nonius, Model SPIRO 601). Drugs: isobaric bupivacaine 0.25% (aside from the drugs used in the standard operation theatre). Computer software: computer generated random tables (for randomization) and SPSS 22 (for data analysis) Thoracic epidural (TEP): A pre-procedural ultrasound examination will be done to first identify the correct targeted thoracic level. To accomplish this, the transducer will be placed in the parasagittal plane approximately 5 cm from midline. The thoracic level will be determined by identifying the 12th rib and counting in a cephalad direction until the targeted level is marked. All epidurals will be performed under all aseptic precautions with a 17-gauge Tuohy needle and 19 G flex-tip catheters. Using the loss of resistance to saline technique, catheters will be inserted 4 cm into the epidural space and a suitable test dose will be administered to exclude intravascular or sub-arachnoid injection Bupivacaine 0.25% of 7.5-12 ml volume will be given through the epidural catheter then continuous infusion of bupivacaine 0.1% will be infused at a rate of 5 ml/h up to 15 ml/h with bolus infusion of 5 to 10 ml of the infusion mixture for breakthrough pain. The block height will be tested using pin prick method. After spirometry testing and diaphragmatic ultrasound, the infusion of TEP will be gradually weaned of and the catheter will be removed under complete aseptic precautions. Thoracic paravertebral block: (TPVB) The Ultrasound-probe will be centered on T7. The sagittal technique at the transverse process, in-plane, will be used. The 19 gauge echogenic needle will be inserted in-plane at the lower border of the transducer and advanced in a cephalad position with real-time ultrasound sonography. Injection of small amounts of fluid (hydro-dissection) will aid in needle tip location. When the needle tip reaches the paravertebral space, 7.5-12 ml Bupivacaine 0.25% will be slowly injected after negative aspiration. The endpoint for a successful block is anterior displacement of the pleura. The catheter will be then inserted through the needle and positioned up to 3 cm from skin entry directing upwards in the paravertebral space then continuous infusion of bupivacaine 0.1% will be infused at a rate of 5 ml/h up to 15 ml/h with bolus infusion of 5 to 10 ml of the infusion mixture for breakthrough pain.

Official Title
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Evaluation of Post-operative Pulmonary Function After Open Kidney Surgery: Comparison Between Thoracic Epidural and Paravertebral Block

Conditions
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Pulmonary Function

Intervention / Treatment
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* Procedure: thoracic epidural block
* Procedure: paravertebral block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA II, III elective kidney surgery Exclusion Criteria: patient refusal contraindications to neuraxial blocks pneumonectomy planed postoperative mechanical ventilatoin

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: thoracic epidural group<br>patients in this group will receive ultrasound guided thoracic epidural block preoperatively for pain management, continuous infusion of 0.5% bupivacaine through epidural catheter during operation and early post-operative period | Procedure: thoracic epidural block<br>* thoracic epidural block with bupivacaine 0.25% will be given in the 8th thoracic space using ultrasound<br>|
| Active Comparator: paravertebral group<br>patients in this group will receive ultrasound guided pararvertebral block preoperatively for pain management, continuous infusion of paravertebral bupivacaine 0.5% through paravetebral catheter during operation and early post-operative period | Procedure: paravertebral block<br>* paravertebral block with 0.25 bupivacaine will be given at the level of the incision using ultrasound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vital capacity | measured by spirometer (Enraf-Nonius, Model SPIRO 601 medical Technologies) | 24 hours after operation | 
| forced vital capacity | measured by spirometer (Enraf-Nonius, Model SPIRO 601 medical Technologies) | 24 hours after operation | 
| forced expiratory volume in one second | measured by spirometer (Enraf-Nonius, Model SPIRO 601 medical Tecnologies) | 24 hours after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score | pain will be assessed using VAS score, it provides a range of scores from 0-100. A higher score indicates greater pain intensity. | 24 hours after operation | 
| diaphragmatic excursion | ultrasound assessment of diaphragmatic excursion | 24 hours after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kidney surgery, thoracic epidural block, paravertebral block