Assiut University Hospital
Asyut, 71516, Egypt
NCT Number: NCT03885583
To assess the respiratory and analgesic effects of continuous thoracic paravertebral block versus thoracic epidural in patients undergoing kidney surgery
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Asyut, 71516, Egypt
Study tools
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
thoracic epidural block with bupivacaine 0.25% will be given in the 8th thoracic space using ultrasound
paravertebral block with 0.25 bupivacaine will be given at the level of the incision using ultrasound
Time frame: 24 hours after operation
measured by spirometer (Enraf-Nonius, Model SPIRO 601 medical Technologies)
Time frame: 24 hours after operation
measured by spirometer (Enraf-Nonius, Model SPIRO 601 medical Technologies)
Time frame: 24 hours after operation
measured by spirometer (Enraf-Nonius, Model SPIRO 601 medical Tecnologies)
Time frame: 24 hours after operation
pain will be assessed using VAS score, it provides a range of scores from 0-100. A higher score indicates greater pain intensity.
Time frame: 24 hours after operation
ultrasound assessment of diaphragmatic excursion
Assiut University
Other
Evaluation of Post-operative Pulmonary Function After Open Kidney Surgery: Comparison Between Thoracic Epidural and Paravertebral Block
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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