Lung Diseases Clinical Trial
Official title:
Comparison Of Erector Spinae Plane Block And Thoracal Paravertebral Block For Postoperative Analgesia Management Following Vıdeo Assisted Thoracic Surgery
NCT number | NCT03854773 |
Other study ID # | MedipolU |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2019 |
Est. completion date | May 1, 2020 |
Verified date | May 2020 |
Source | Medipol University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Video assisted thoracic surgery (VATS) has recently been evaluated as the standard surgical procedure for lung surgery. Although VATS is less painful than thoracotomy, patients may feel severe pain during the first hours at postoperative period. Analgesia management is very important for these patients in postoperative period since insufficient analgesia can cause pulmonary complications such as atelectasis, pneumonia and increased oxygen consumption. The ultrasound (US) guided erector spina plane (ESP) block is a novel interfacial plan block defined by Forero et al. at 2016. ESP block provides thoracic analgesia at T5 level and abdominal analgesia at T7-9 level. Visualization of sonoanatomy with US is easy, and the spread of local anesthesic agents can be easily seen under the erector spinae muscle (12). Thus, analgesia occurs in several dermatomes with cephalad-caudad way. In the literature, there is not still any randomized study evaluating ESP block efficiency for postoperative analgesia management after VATS. The aim of this study is to compare US-guided ESP block and TPVB for postoperative analgesia management after VATS.
Status | Completed |
Enrollment | 90 |
Est. completion date | May 1, 2020 |
Est. primary completion date | May 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - American Society of Anesthesiologists (ASA) classification I-II - scheduled for VATS under general anesthesia Exclusion Criteria: - history of bleeding diathesis, - receiving anticoagulant treatment, - known local anesthetics and opioid allergy, - infection of the skin at the site of the needle puncture, - pregnancy or lactation, - patients who do not accept the procedure |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul Medipol University Hospital | Istanbul | Bagcilar |
Lead Sponsor | Collaborator |
---|---|
Medipol University |
Turkey,
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451. — View Citation
Forero M, Rajarathinam M, Adhikary S, Chin KJ. Continuous Erector Spinae Plane Block for Rescue Analgesia in Thoracotomy After Epidural Failure: A Case Report. A A Case Rep. 2017 May 15;8(10):254-256. doi: 10.1213/XAA.0000000000000478. — View Citation
Vogt A, Stieger DS, Theurillat C, Curatolo M. Single-injection thoracic paravertebral block for postoperative pain treatment after thoracoscopic surgery. Br J Anaesth. 2005 Dec;95(6):816-21. Epub 2005 Sep 30. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | opioid consumption | The primary aim is to compare perioperative and postoperative opioid consumption | Change from Baseline Postoperative Visual Analogue Score at 48 hours | |
Secondary | Visual analogue scores (VAS) | Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores at rest and during cough will be recorded at postoperative 1, 2, 4, 8, 16 and 24 hours. | postoperative 1, 2, 4, 8, 16, 24, and 48 hours |
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