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
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Function||Procedure: thoracic epidural block Procedure: paravertebral block||Not Applicable|
- 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 (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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|
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
- vital capacity [ Time Frame: 24 hours after operation ]measured by spirometer (Enraf-Nonius, Model SPIRO 601 medical Technologies)
- forced vital capacity [ Time Frame: 24 hours after operation ]measured by spirometer (Enraf-Nonius, Model SPIRO 601 medical Technologies)
- forced expiratory volume in one second [ Time Frame: 24 hours after operation ]measured by spirometer (Enraf-Nonius, Model SPIRO 601 medical Tecnologies)
- 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.
- diaphragmatic excursion [ Time Frame: 24 hours after operation ]ultrasound assessment of diaphragmatic excursion
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885583
|Contact: Khaled A Abdelrahman, MDfirstname.lastname@example.org|
|Assiut University Hospital|
|Assiut, Egypt, 71516|
|Contact: Hamdy A Youssef, MD 00208824132.4 email@example.com|
|Study Director:||Mohammed G Abdelraheem, MD||Assiut University|