Dexmedetomidine and Morphine as Adjuvants to US Guided Erector Spinae Plane Blocks in Elective Thoracic Surgeries
NCT ID: NCT05843344
Last Updated: 2023-05-06
Study Results
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Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2023-05-01
2025-05-01
Brief Summary
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Detailed Description
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The use of adjuvants has been studied to a limited extent in ESPB. Dexmedetomidine and dexamethasone have been tried as adjuvants in ESPB and it has been shown that dexmedetomidine is more effective in block prolongation and post-operative opioid consumption. According to our knowledge, morphine has not been used yet as an adjuvant for ESPB.
Therefore, the investigators will perform a randomized controlled trial in order to compare morphine and dexmedetomidine as adjuvants in ESPB in elective thoracotomies in terms of intraoperative and post-operative opioid consumption. Intraoperative opioid consumption will be guided by vital signs and Nociception-Level Index (NOL) and post-operative opioid consumption will be measured by the amount of morphine consumed by the patient during the first 48 hours post-operatively. Secondary outcomes will also be recorded.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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ropivacaine and morphine group
erector spinae plane block with a combination of ropivacaine and morphine
erector spinae plane block with a combination of ropivacaine and morphine
Before surgery, a US guided ESPB will be performed, and a catheter will be placed. Serratus Anterior Plane Block (SAPB) will be also performed without catheter placement. 20 mL of Ropivacaine 0.375% will be injected in the SAPB. In this group, 19 mL of 0.375% Ropivacaine + 2 mg (1mL) of morphine will be injected in the ESPB. Continuous peripheral nerve catheters will be placed for postoperative analgesia under the Erector Spinae muscle. A pump of 497 ml of 0.2 % ropivacaine + 6 mg of morphine (contained in 3 mL) will be connected to the catheter after the end of the surgery, and the continuous dose will be 10 mL/hr
ropivacaine and dexmedetomidine group
erector spinae plane block with a combination of ropivacaine and dexmedetomidine
erector spinae plane block with a combination of ropivacaine and dexmedetomidine
Before surgery, a US guided ESPB will be performed, and a catheter will be placed. SAPB will be also performed without catheter placement. 20 mL of Ropivacaine 0.375% will be injected in the SAPB. In this group, 19 mL of 0.375% Ropivacaine +0.5 mcg/kg (1mL) of dexmedetomidine will be injected in the ESPB. Continuous peripheral nerve catheters will be placed for postoperative analgesia under the Erector Spinae muscle. A pump of 497 ml of 0.2 % ropivacaine + 200 mcg of dexmedetomidine (contained in 3 mL) will be connected to the catheter after the end of the surgery, and the continuous dose will be 10 mL/hr
ropivacaine group
erector spinae plane block with ropivacaine only
erector spinae plane block with ropivacaine only
Before surgery, a US guided ESPB will be performed, and a catheter will be placed. SAPB will be also performed without catheter placement. 20 mL of Ropivacaine 0.375% will be injected in the SAPB. In this group, 19 mL of 0.375% Ropivacaine +1 mL of normal saline will be injected in the ESPB. Continuous peripheral nerve catheters will be placed for postoperative analgesia under the Erector Spinae muscle. A pump of 497 ml of 0.2 % ropivacaine + 3 mL of normal saline will be connected to the catheter after the end of the surgery, and the continuous dose will be 10 mL/hr
Interventions
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erector spinae plane block with a combination of ropivacaine and morphine
Before surgery, a US guided ESPB will be performed, and a catheter will be placed. Serratus Anterior Plane Block (SAPB) will be also performed without catheter placement. 20 mL of Ropivacaine 0.375% will be injected in the SAPB. In this group, 19 mL of 0.375% Ropivacaine + 2 mg (1mL) of morphine will be injected in the ESPB. Continuous peripheral nerve catheters will be placed for postoperative analgesia under the Erector Spinae muscle. A pump of 497 ml of 0.2 % ropivacaine + 6 mg of morphine (contained in 3 mL) will be connected to the catheter after the end of the surgery, and the continuous dose will be 10 mL/hr
erector spinae plane block with a combination of ropivacaine and dexmedetomidine
Before surgery, a US guided ESPB will be performed, and a catheter will be placed. SAPB will be also performed without catheter placement. 20 mL of Ropivacaine 0.375% will be injected in the SAPB. In this group, 19 mL of 0.375% Ropivacaine +0.5 mcg/kg (1mL) of dexmedetomidine will be injected in the ESPB. Continuous peripheral nerve catheters will be placed for postoperative analgesia under the Erector Spinae muscle. A pump of 497 ml of 0.2 % ropivacaine + 200 mcg of dexmedetomidine (contained in 3 mL) will be connected to the catheter after the end of the surgery, and the continuous dose will be 10 mL/hr
erector spinae plane block with ropivacaine only
Before surgery, a US guided ESPB will be performed, and a catheter will be placed. SAPB will be also performed without catheter placement. 20 mL of Ropivacaine 0.375% will be injected in the SAPB. In this group, 19 mL of 0.375% Ropivacaine +1 mL of normal saline will be injected in the ESPB. Continuous peripheral nerve catheters will be placed for postoperative analgesia under the Erector Spinae muscle. A pump of 497 ml of 0.2 % ropivacaine + 3 mL of normal saline will be connected to the catheter after the end of the surgery, and the continuous dose will be 10 mL/hr
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* local inflammation
* severe respiratory distress ( breathing dependence on accessory muscles)
* severe spinal deformities
* severe ipsilateral diaphragmatic paresis
* morbid obesity (BMI\>35 kg/m2)
* blood coagulation disorder
* known contraindication for administration of dexmedetomidine or morphine
* severe cardiovascular disease
* systematic use of opioids due to chronic pain
* renal or hepatic failure
* patients who refuse to participate.
25 Years
80 Years
ALL
No
Sponsors
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Sotiria General Hospital
OTHER
Dr Kassiani Theodoraki
OTHER
Responsible Party
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Dr Kassiani Theodoraki
Professor of Anesthesiology
Principal Investigators
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Kassiani Theodoraki, PhD, DESA
Role: PRINCIPAL_INVESTIGATOR
Aretaieion UNiversity Hospital, National and Kapodistrin University of Athens, Greece
Locations
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Sotiria Thoracic Diseases Hospital
Athens, , Greece
Aretaieion University Hospital
Athens, , Greece
Countries
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Central Contacts
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Facility Contacts
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Kassiani Theodoraki, PhD, DESA
Role: primary
References
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Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007.
A Mesbah, MB BCh FCAI FRCA, J Yeung, MB ChB FRCA PhD FFICM, F Gao, MB BS PhD MPhil FRCA MD FFICM, Pain after thoracotomy, BJA Education, Volume 16, Issue 1, January 2016, Pages 1-7, https://doi.org/10.1093/bjaceaccp/mkv005
Mazo V, Sabate S, Canet J, Gallart L, de Abreu MG, Belda J, Langeron O, Hoeft A, Pelosi P. Prospective external validation of a predictive score for postoperative pulmonary complications. Anesthesiology. 2014 Aug;121(2):219-31. doi: 10.1097/ALN.0000000000000334.
Yeung JH, Gates S, Naidu BV, Wilson MJ, Gao Smith F. Paravertebral block versus thoracic epidural for patients undergoing thoracotomy. Cochrane Database Syst Rev. 2016 Feb 21;2(2):CD009121. doi: 10.1002/14651858.CD009121.pub2.
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.
Kot P, Rodriguez P, Granell M, Cano B, Rovira L, Morales J, Broseta A, Andres J. The erector spinae plane block: a narrative review. Korean J Anesthesiol. 2019 Jun;72(3):209-220. doi: 10.4097/kja.d.19.00012. Epub 2019 Mar 19.
Hassan ME, Wadod MAA. Serratus anterior plane block and erector spinae plane block in postoperative analgesia in thoracotomy: A randomised controlled study. Indian J Anaesth. 2022 Feb;66(2):119-125. doi: 10.4103/ija.ija_257_21. Epub 2022 Feb 24.
Hamed MA, Fargaly OS, Abdelghaffar RA, Moussa MA, Algyar MF. The role of dexmedetomidine as an adjuvant for high-thoracic erector spinae plane block for analgesia in shoulder arthroscopy; a randomized controlled study. BMC Anesthesiol. 2023 Feb 15;23(1):53. doi: 10.1186/s12871-023-02014-2.
Gao Z, Xiao Y, Wang Q, Li Y. Comparison of dexmedetomidine and dexamethasone as adjuvant for ropivacaine in ultrasound-guided erector spinae plane block for video-assisted thoracoscopic lobectomy surgery: a randomized, double-blind, placebo-controlled trial. Ann Transl Med. 2019 Nov;7(22):668. doi: 10.21037/atm.2019.10.74.
Ling L, Yang TX, Lee SWK. Effect of Anaesthesia Depth on Postoperative Delirium and Postoperative Cognitive Dysfunction in High-Risk Patients: A Systematic Review and Meta-Analysis. Cureus. 2022 Oct 10;14(10):e30120. doi: 10.7759/cureus.30120. eCollection 2022 Oct.
Suraarunsumrit P, Pathonsmith C, Srinonprasert V, Sangarunakul N, Jiraphorncharas C, Siriussawakul A. Postoperative cognitive dysfunction in older surgical patients associated with increased healthcare utilization: a prospective study from an upper-middle-income country. BMC Geriatr. 2022 Mar 16;22(1):213. doi: 10.1186/s12877-022-02873-3.
Other Identifiers
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492/15-03-2023
Identifier Type: -
Identifier Source: org_study_id
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