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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
90
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
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
Sotiria Thoracic Diseases Hospital
Athens, Greece
Aretaieion University Hospital
Athens, Greece
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.
Time frame: 48 hours post-operatively
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.
Time frame: 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.
Time frame: 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.
Time frame: 24 hours post-operatively
Intraoperative remifentanil consumption
intraoperative remifentanil consumption will be monitored according to nociception level (NOL) index
Time frame: Duration of operation
Intraoperative morphine consumption
Intraoperative morphine consumption will be monitored according to nociception level (NOL) index
Time frame: 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"
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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
Time frame: 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"
Time frame: 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"
Time frame: 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"
Time frame: 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"
Time frame: 48 hours post-operatively
side effects post-operatively
patients will be monitored for any side effects post-operatively
Time frame: 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
Time frame: 48 hours post-operatively
time to first request of analgesia
the time for the first patient for analgesia will be noted
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 48 hours post-operatively
Nausea and vomiting
Incidence of nausea and vomiting will be monitored for the first 24 hours postoperatively
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 48hours post-operatively
Post-operative Delirium (POD) Incidence
Incidence of POD will be assessed
Time frame: 48 hours post-operatively