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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pain, Postoperative, Pain, Acute, Pain, Chronic, Morphine, Dexmedetomidine, Analgesia

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ropivacaine and morphine group<br>erector spinae plane block with a combination of ropivacaine and morphine | Drug: erector spinae plane block with a combination of ropivacaine and morphine<br>* 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<br>* Other names: ropivacaine plus morphine;|
| Active Comparator: ropivacaine and dexmedetomidine group<br>erector spinae plane block with a combination of ropivacaine and dexmedetomidine | Drug: erector spinae plane block with a combination of ropivacaine and dexmedetomidine<br>* 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<br>* Other names: ropivacaine plus dexmedetomidine;|
| Active Comparator: ropivacaine group<br>erector spinae plane block with ropivacaine only | Drug: erector spinae plane block with ropivacaine only<br>* 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<br>* Other names: ropivacaine only;|

What is the study measuring?
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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 |