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

Pulmonary Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03885583
• Other study ID #: aunanesth202019
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: November 30, 2022

Study information

• Verified date: November 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 30, 2022
• Est. primary completion date: August 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• ASA II, III

• elective kidney surgery

Exclusion Criteria:

• patient refusal

• contraindications to neuraxial blocks

• pneumonectomy

• planed postoperative mechanical ventilatoin

Related Conditions & MeSH terms

• Pulmonary Function

Intervention

Procedure:
• thoracic epidural block
thoracic epidural block with bupivacaine 0.25% will be given in the 8th thoracic space using ultrasound
• paravertebral block
paravertebral block with 0.25 bupivacaine will be given at the level of the incision using ultrasound

Locations

Country	Name	City	State
Egypt	Assiut University Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vital capacity	measured by spirometer (Enraf-Nonius, Model SPIRO 601 medical Technologies)	24 hours after operation
Primary	forced vital capacity	measured by spirometer (Enraf-Nonius, Model SPIRO 601 medical Technologies)	24 hours after operation
Primary	forced expiratory volume in one second	measured by spirometer (Enraf-Nonius, Model SPIRO 601 medical Tecnologies)	24 hours after operation
Secondary	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
Secondary	diaphragmatic excursion	ultrasound assessment of diaphragmatic excursion	24 hours after operation