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Post-operative Pulmonary Function After Thoracotomy Under Two Different Techniques

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ClinicalTrials.gov Identifier: NCT03885583
Recruitment Status : Not yet recruiting
First Posted : March 21, 2019
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Khaled Abdelbaky Abdelrahman, Assiut University

Study Description
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Brief Summary:
To assess the respiratory and analgesic effects of continuous thoracic paravertebral block versus thoracic epidural in patients undergoing thoracotomy

Condition or disease Intervention/treatment Phase
Pulmonary Function Procedure: thoracic epidural block Procedure: paravertebral block Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of Post-operative Pulmonary Function After Open Thoracotomy: Comparison Between Thoracic Epidural and Paravertebral Block
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : November 1, 2021
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA II, III
  • elective thoracotomy surgery

Exclusion Criteria:

  • patient refusal
  • contraindications to neuraxial blocks
  • pneumonectomy
  • planed postoperative mechanical ventilatoin
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885583


Contacts
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Contact: Khaled A Abdelrahman, MD 00200882413201 khbaqy@gmail.com

Locations
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Egypt
Assiut University Hospital
Assiut, Egypt, 71516
Contact: Hamdy A Youssef, MD    00208824132.4    hamdyayoussef@yahoo.com   
Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Mohammed G Abdelraheem, MD Assiut University
More Information
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Responsible Party: Khaled Abdelbaky Abdelrahman, Assistant professor, Assiut University
ClinicalTrials.gov Identifier: NCT03885583    
Other Study ID Numbers: aunanesth202019
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Khaled Abdelbaky Abdelrahman, Assiut University:
thoracotomy
thoracic epidural block
paravertebral block