- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07782073
Comparison Between Paravertebral and Erector Spinal Block Efficacy in Robotic Thoracic Surgeries (TPVB vs ESP)
A Prospective Comparison of Continues Catheter Paravertebral Block vs Continues Catheter Erector Spinal Block in Patients Undergoing Robotic Assistant Thoracic Surgery
The overall goal of this work is to find the preferred continues catheter- based thoracic block for patients who undergoing major ROBOTIC assisted thoracic surgery (Lobectomy, multiple segmental resection and thoracotomy). Specifically, this project aims to complete the following:
- To compare analgesic efficiency of continuous TPVB vs ESP block in patients undergoing major robotic thoracoscopic operation
- To assess failure rate, time to catheter placement and patient satisfaction of each block group
- To compare complication rate of each block
Study Overview
Status
Intervention / Treatment
Detailed Description
All adult patients undergoing major robotic thoracic procedures, such as Lobectomy, multiple segmental resection and thoracotomy. The recruitment period is planned for approximately 1 year. The follow-up period will be from admission until hospital discharge.
Video-assisted thoracic surgery (VATS) is a type of minimally invasive thoracic surgery that can remove parts of the diseased lung and lymph nodes. In video-assisted thoracoscopic surgery (VATS), a small tube called a thoracoscope is inserted through a small cut (incision) between the ribs. At the end of the tube is a small camera. This lets the surgeon see the entire chest cavity without having to open up the chest or spread the ribs. The surgeon then removes lung tissue with specially designed instruments inserted through one or two additional small incisions. The VATS technique can be used for other types of chest procedures involving the lungs, esophagus, thymus, pleural or pericardium besides lung cancer surgery.
Thoracic paravertebral block (TPVB) is the technique of injecting local anesthetic adjacent to the thoracic vertebra close to where the spinal nerves emerge from the intervertebral foramina. This results in ipsilateral somatic and sympathetic nerve blockade in multiple contiguous thoracic dermatomes above and below the site of injection
In recent years a new conceptual type of regional anesthesia has emerged: the Erector Spinae Plane Block (ESP block). Originally it was described in 2016 in a case report regarding analgesia intervention for thoracic neuropathic pain. Since then, there has been growing interest and research adding experience about the ESP block for pain control after thoracic and abdominal surgery and also traumatic injury of chest and abdomen. Current literature is limited to approximately 60 publications, the majority of which is case reports and case series.
Comparison of both techniques:
In thoracic surgery, both the Erector Spinae Plane (ESP) block and the Thoracic Paravertebral Block (TPVB) are utilized for analgesia.
Erector Spinae Plane (ESP) Block:
Advantages:
- Technical Simplicity: The ESP block is generally easier to perform due to its superficial anatomical location, making it more accessible, especially for practitioners less experienced with deeper blocks.
- Safety Profile: There's a reduced risk of complications such as pneumothorax because the injection site is farther from the pleura and major vascular structures.
- Analgesic Efficacy: Studies suggest that ESP blocks provide effective analgesia for thoracic surgeries, with benefits comparable to TPVB when a similar number of injections are administered.
Disadvantages:
- Potentially Limited Analgesic Coverage: While effective, the ESP block may not provide as extensive analgesic coverage as TPVB in some cases, potentially necessitating additional analgesic measures.
- Limited Long-Term Data: As a relatively newer technique, long-term efficacy and safety data are less comprehensive compared to TPVB.
Thoracic Paravertebral Block (TPVB):
Advantages:
- Established Efficacy: TPVB has a long-standing history of providing reliable analgesia for thoracic surgeries, with well-documented outcomes.
- Comprehensive Analgesia: It offers effective unilateral analgesia, which can be advantageous for procedures involving one side of the thorax.
Disadvantages:
- Technical Complexity: TPVB requires a higher degree of technical skill due to the proximity to the pleura and neurovascular structures, increasing the risk of complications.
- Risk of Complications: There's a higher potential for adverse events such as pneumothorax, vascular puncture, and hypotension.
In summary, both ESP and TPVB are effective for analgesia in thoracic surgery. The choice between them should be guided by patient-specific factors, surgical requirements, and the clinician's expertise with each technique.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beersheba, Israel
- Soroka Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥18 years
- All patients undergo major robotic thoracic surgery
Exclusion Criteria:
- Patients who refuse to participate in the study.
- Patients who are unable to give an informed consent.
- Patients with local inflammation at the puncture site
- Patients with known allergy to local anesthetisc
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: group A - TPVB
continues paravertebral block
|
Thoracic paravertebral block (TPVB) is the technique of injecting local anesthetic adjacent to the thoracic vertebra close to where the spinal nerves emerge from the intervertebral foramina. This results in ipsilateral somatic and sympathetic nerve blockade in multiple contiguous thoracic dermatomes above and below the site of injection It is effective in treating acute and chronic pain of unilateral origin from the chest and abdomen. Bilateral use of TPVB has also been described. Our understanding of the safety and efficacy of TPVB has improved significantly in the last two decades, prompting its use in children and neonates and for surgical anesthesia The TPVB is used to provide anesthesia and analgesia for breast surgery, surgery that requires coverage of the axilla (eg, creation of dialysis access, axillary lymph node dissection), or for thoraco-abdominal surgery as an alternative to thoracic epidural. The selected level for the block should be as close to the loca |
|
Active Comparator: group B - ESP
continues erector spinal block
|
we started performing ESP block for postoperative pain control in thoracic and abdominal surgery, with very satisfactory results so far. The block appears to be sufficient for postoperative pain control and the complications are yet to be seen. The results of our previous study show that ESP block is superior to pectoralis and serratus blocks-also used in thoracic surgery-in regard for a larger area of analgesia, easier injection, and longer duration. Also, it offers better safety profile than neuraxial analgesia or the thoracic paravertebral block The current literature suggests that ESP block is an excellent adjuvant to multi-modal analgesia not just for thoracic, but for abdominal surgery as well. It is an ultrasound guided interfacial block, achieved by injecting the local anesthetic solution between the transverse process and the erector spinae muscles (iliocostalis, longissimus, and spinalis). It can be performed either as a single shot or as a continuous catheter techniqu |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post operative opioid consumption
Time Frame: From completion of surgery through hospital discharge, assessed up to 24 hours postoperatively
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measured by MME (morphine equivalent)
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From completion of surgery through hospital discharge, assessed up to 24 hours postoperatively
|
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post operative pain
Time Frame: Every 2 hours starting from PACU admission until hospital discharge, assessed up to 96 hours postoperatively.
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measured by Visual Analog Scale (VAS); measured from 0 to 5, when 5- is maximal pain and 0 - no pain at all.
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Every 2 hours starting from PACU admission until hospital discharge, assessed up to 96 hours postoperatively.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient satisfaction
Time Frame: immediately before discharge from the hospital
|
measured by score of 1 to 5, when 1 is the lowest (very not satisfied) and 5 is the highest (Very satisfied).
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immediately before discharge from the hospital
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 1. H,Nagano, T. Suda, Advantages and disadvantages of robotic and uniportal video-assisted thoracoscopic surgery, Video-assist Thorac Surg 2021;6:14 | http://dx.doi.org/ 2. Veronesi G. Robotic lobectomy and segmentectomy for lung cancer: results and operating technique. J Thorac Dis 2015;7 3. Novellis P, Bottoni E, Vonlaz E, et al. Robotic surgery, video-assisted thoracic surgery, and open surgery for early stage lung cancer: comparison of costs and outcomes at a single institute. J Thorac Dis 2018;1 4. Louie BE, Farivar AS, Aye RW, et al. Early experience with robotic lung resection results in similar operative outcomes and mobidity with compared with matched video-assisted thoracoscopic surgery cases. Ann Thorac Surg 2012;93:1598-6 5. Karmakar M., Thoracic Paravertebral Block, Anesthesiology 2001; 95:771-80 6. S. Feray,J. Lubach,G. P. Joshi,F. Bonnet, M. Van de Velde, PROSPECT guidelines for video-assisted thoracoscopic surgery: a systematic review and procedure-specific postoperative pain management recommendations, Anaesthesia 2022, 77, 311-325 7. Krishna, S.N.; Chauhan, S.; Bhoi, D.; Kaushal, B.; Hasija, S.; Sangdup, T.; Bisoi, A.K. Bilateral Erector Spinae Plane Block for Acute Post-Surgical Pain in Adult Cardiac Surgical Patients: A Randomized Controlled Trial. J. Cardiothorac. Vasc. Anesth. 2019, 33, 368-375. 8. Kawagoe, I.; Hayashida, M.; Satoh, D.; Kochiyama, T.; Fukuda, M.; Kishii, J. Postoperative analgesia in patients undergoing robot-assisted thoracic surgery: A comparison between thoracic epidural analgesia and intercostal nerve block combined with intravenous patient-controlled analgesia. Ann. Palliat. Med. 2021, 10, 1985-1993 9. A. Pawa,, T. Wojcikiewicz,, A. Barron, ,K. El-Boghdadly,, Paravertebral Blocks: Anatomical, Practical, and Future Concepts, Current Anesthesiology Reports (2019) 9:263-270 10. A. Ardon, J. Lee, C. D. Franco, K. T. Riutort, R. A. Greengrass, Paravertebral block: anatomy and relevant safety issues, Korean J Anesthe
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 0349-24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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