Dexmedetomidine and Morphine as Adjuvants to US Guided Erector Spinae Plane Blocks in Elective Thoracic Surgeries

The aim of this study will be to compare the effects of morphine versus dexmedetomidine when used as adjuvants to local anesthetic (Ropivacaine) in Erector Spinae Plane Block under ultrasound guidance. A group without an adjuvant will also be compared to the groups.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain, Postoperative; Analgesia; Pain, Acute; Dexmedetomidine; Pain, Chronic; Morphine
• Intervention / Treatment: Drug: erector spinae plane block with a combination of ropivacaine and morphine; Drug: erector spinae plane block with a combination of ropivacaine and dexmedetomidine; Drug: erector spinae plane block with ropivacaine only

Detailed Description

Erector Spinae Plane Block (ESPB) was first introduced in 2016 as a treatment technique for chronic thoracic neuropathic pain, and rapidly became popular in peri-operative medicine due to its relatively simple technique and low complication rate. It has been also used extensively in thoracic surgery. According to a systematic review, ESPB can be used effectively as part of multimodal analgesia in thoracic surgery since, when used, opioid consumption decreases.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kassiani Theodoraki, PhD DESA; Phone Number: +306974634162; Email: ktheodoraki@hotmail.com

Study Locations

• Greece
  • Athens, Greece, 11528
    • ARETAIEION University Hospital
    • Contact: Kassiani Theodoraki, PhD, DESA; Phone Number: +306974634162
  • Athens, Greece, 11527
    • Sotiria Thoracic Diseases Hospital
    • Contact: Dimitra Papadopoulou, MD, MSc; Phone Number: +306942466678; Email: dim.dim.pap@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patients undergoing elective thoracotomy for any cause (ASA I-III)

Exclusion Criteria:

• known allergy to local anesthetic
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ropivacaine and morphine group; erector spinae plane block with a combination of ropivacaine and morphine	Drug: 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; Other Names: ropivacaine plus morphine
Active Comparator: ropivacaine and dexmedetomidine group; erector spinae plane block with a combination of ropivacaine and dexmedetomidine	Drug: 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; Other Names: ropivacaine plus dexmedetomidine
Active Comparator: ropivacaine group; erector spinae plane block with ropivacaine only	Drug: 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 Names: ropivacaine only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intravenous morphine consumption in the first 48 hours post-operatively	Patients will be tracked for cumulative morphine consumption through a patient controlled analgesia device for the first 48 hours.	48 hours post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IV morphine consumption in the first 6 hours	Patients will be tracked for cumulative morphine consumption through a patient controlled analgesia device for the first 6 hours.	6 hours post-operatively
IV morphine consumption in the first 12 hours	Patients will be tracked for cumulative morphine consumption through a patient controlled analgesia device for the first 12 hours.	12 hours post-operatively
IV morphine consumption in the first 24 hours	Patients will be tracked for cumulative morphine consumption through a patient controlled analgesia device for the first 24 hours.	24 hours post-operatively
Intraoperative remifentanil consumption	intraoperative remifentanil consumption will be monitored according to nociception level (NOL) index	Duration of operation
Intraoperative morphine consumption	Intraoperative morphine consumption will be monitored according to nociception level (NOL) index	Duration of operation
Pain score after surgery (PACU)	Pain score by the use of Numeric Rating Scale (NRS) on arrival at PACU , from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"	immediately post-operatively
Pain score 6 hours post-operatively	Pain score by the use of Numeric Rating Scale (NRS) 6 hours post-operatively , from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"	6 hours post-operatively
Pain score 12 hours post-operatively	Pain score by the use of Numeric Rating Scale (NRS) 12 hours post-operatively , from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"	12 hours post-operatively
Pain score 24 hours post-operatively	Pain score by the use of Numeric Rating Scale (NRS) 24 hours post-operatively , from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"	24 hours post-operatively
Pain score 48 hours post-operatively	Pain score by the use of Numeric Rating Scale (NRS) 48 hours post-operatively , from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"	48 hours post-operatively
side effects post-operatively	patients will be monitored for any side effects post-operatively	48 hours post-operatively
satisfaction from post-operative analgesia	satisfaction from post-operative analgesia on a four-point Likert scale with 1 marked as minimal satisfaction and 4 as maximal satisfaction	48 hours post-operatively
time to first request of analgesia	the time for the first patient for analgesia will be noted	48 hours post-operatively
Patient agitation- sedation status post-operatively (PACU)	Patient status will be monitored using Richmond Agitation Sedation Scale (RASS) on arrival at PACU. This scale can range from -5 (unarousable) to +4 (combative) and 0 means alert and calm	Immediately post-operatively
Patient agitation- sedation status in the first 6 hours	Patient status will be monitored using Richmond Agitation Sedation Scale (RASS) 6 hours post-operatively. This scale can range from -5 (unarousable) to +4 (combative) and 0 means alert and calm	6 hours post-operatively
Patient agitation- sedation status in the first 12 hours	Patient status will be monitored using Richmond Agitation Sedation Scale (RASS) 12 hours postoperatively. This scale can range from -5 (unarousable) to +4 (combative) and 0 means alert and calm	12 hours post-operatively
Patient agitation- sedation status in the first 24 hours	Patient status will be monitored using Richmond Agitation Sedation Scale (RASS) 24 hours postoperatively. This scale can range from -5 (unarousable) to +4 (combative) and 0 means alert and calm	24 hours post-operatively
Patient agitation- sedation status in the first 48 hours	Patient status will be monitored using Richmond Agitation Sedation Scale (RASS) 48 hours postoperatively. This scale can range from -5 (unarousable) to +4 (combative) and 0 means alert and calm	48 hours post-operatively
Nausea and vomiting	Incidence of nausea and vomiting will be monitored for the first 24 hours postoperatively	24 hours post-operatively
Chronic pain 3 months after operation	Incidence of chronic pain using douleur neuropathique 4 (DN4) pain scale 3 months after the operation. This scale can range from 0 to 10 and 10 means a worse outcome.	3 months post-operatively
Chronic pain 6 months after operation	Incidence of chronic pain using douleur neuropathique 4 (DN4) pain scale 6 months after the operation. This scale can range from 0 to 10 and 10 means a worse outcome.	6 months post-operatively
Post-operative cognitive disorder (POCD)	Incidence of POCD will be assessed using Mini-Mental State Examination (MMSE) pre-operatively and 48 hours post-operatively	48hours post-operatively
Post-operative Delirium (POD) Incidence	Incidence of POD will be assessed	48 hours post-operatively

Collaborators and Investigators

• Sponsor: Dr Kassiani Theodoraki
• Collaborators: Sotiria General Hospital
• Investigators: Principal Investigator: Kassiani Theodoraki, PhD, DESA, Aretaieion UNiversity Hospital, National and Kapodistrin University of Athens, Greece

Publications and helpful links

General Publications

• Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007.
• 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.
• 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.
• 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.
• 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.
• 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
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): May 1, 2025
• Study Completion (Anticipated): May 1, 2025

Study Registration Dates

• First Submitted: April 12, 2023
• First Submitted That Met QC Criteria: May 3, 2023
• First Posted (Estimate): May 4, 2023

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Chronic Pain; Acute Pain; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Anesthetics, Local; Dexmedetomidine; Ropivacaine; Morphine
• Other Study ID Numbers: 492/15-03-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No