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

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

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

Study Overview

• Status: Completed
• Conditions: Pulmonary Function
• Intervention / Treatment: Procedure: thoracic epidural block; Procedure: paravertebral block

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71516
    • Assiut University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA II, III
• elective kidney surgery

Exclusion Criteria:

• patient refusal
• contraindications to neuraxial blocks
• pneumonectomy
• planed postoperative mechanical ventilatoin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: thoracic epidural group; 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; thoracic epidural block with bupivacaine 0.25% will be given in the 8th thoracic space using ultrasound
ACTIVE_COMPARATOR: paravertebral group; 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; paravertebral block with 0.25 bupivacaine will be given at the level of the incision using ultrasound

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Mohammed G Abdelraheem, MD, Assiut University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2019
• Primary Completion (ACTUAL): August 29, 2022
• Study Completion (ACTUAL): November 30, 2022

Study Registration Dates

• First Submitted: March 20, 2019
• First Submitted That Met QC Criteria: March 20, 2019
• First Posted (ACTUAL): March 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 2, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: paravertebral block; kidney surgery; thoracic epidural block
• Other Study ID Numbers: aunanesth202019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No