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Completed

NCT Number: NCT03885583

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

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

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University Hospital

Asyut, 71516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA II, III
  • elective kidney surgery

Exclusion criteria

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

Treatment and study plan

Thoracic epidural block

Procedure

thoracic epidural block with bupivacaine 0.25% will be given in the 8th thoracic space using ultrasound

paravertebral block

Procedure

paravertebral block with 0.25 bupivacaine will be given at the level of the incision using ultrasound

Primary outcomes

  1. vital capacity

    Time frame: 24 hours after operation

    measured by spirometer (Enraf-Nonius, Model SPIRO 601 medical Technologies)

  2. forced vital capacity

    Time frame: 24 hours after operation

    measured by spirometer (Enraf-Nonius, Model SPIRO 601 medical Technologies)

  3. forced expiratory volume in one second

    Time frame: 24 hours after operation

    measured by spirometer (Enraf-Nonius, Model SPIRO 601 medical Tecnologies)

Secondary outcomes

  1. pain score

    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.

  2. diaphragmatic excursion

    Time frame: 24 hours after operation

    ultrasound assessment of diaphragmatic excursion

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 21, 2019
Registry last updated
Dec 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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