Dexmedetomidine and Morphine as Adjuvants to US Guided Erector Spinae Plane Blocks in Elective Thoracic Surgeries
- Conditions
- Pain, PostoperativeMorphineDexmedetomidineAnalgesiaPain, AcutePain, Chronic
- Interventions
- Registration Number
- NCT05843344
- Lead Sponsor
- Dr Kassiani Theodoraki
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 90
- patients undergoing elective thoracotomy for any cause (ASA I-III)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 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 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 ropivacaine group erector spinae plane block with ropivacaine only erector spinae plane block with ropivacaine only
- Primary Outcome Measures
Name Time Method Intravenous morphine consumption in the first 48 hours post-operatively 48 hours post-operatively Patients will be tracked for cumulative morphine consumption through a patient controlled analgesia device for the first 48 hours.
- Secondary Outcome Measures
Name Time Method IV morphine consumption in the first 6 hours 6 hours post-operatively Patients will be tracked for cumulative morphine consumption through a patient controlled analgesia device for the first 6 hours.
IV morphine consumption in the first 12 hours 12 hours post-operatively Patients will be tracked for cumulative morphine consumption through a patient controlled analgesia device for the first 12 hours.
IV morphine consumption in the first 24 hours 24 hours post-operatively Patients will be tracked for cumulative morphine consumption through a patient controlled analgesia device for the first 24 hours.
Pain score 24 hours post-operatively 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"
side effects post-operatively 48 hours post-operatively patients will be monitored for any side effects post-operatively
Patient agitation- sedation status in the first 12 hours 12 hours post-operatively 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
Nausea and vomiting 24 hours post-operatively Incidence of nausea and vomiting will be monitored for the first 24 hours postoperatively
Post-operative cognitive disorder (POCD) 48hours post-operatively Incidence of POCD will be assessed using Mini-Mental State Examination (MMSE) pre-operatively and 48 hours post-operatively
Post-operative Delirium (POD) Incidence 48 hours post-operatively Incidence of POD will be assessed
Intraoperative remifentanil consumption Duration of operation intraoperative remifentanil consumption will be monitored according to nociception level (NOL) index
Intraoperative morphine consumption Duration of operation Intraoperative morphine consumption will be monitored according to nociception level (NOL) index
Pain score after surgery (PACU) immediately post-operatively 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"
Pain score 48 hours post-operatively 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 to first request of analgesia 48 hours post-operatively the time for the first patient for analgesia will be noted
Patient agitation- sedation status post-operatively (PACU) Immediately post-operatively 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
Patient agitation- sedation status in the first 24 hours 24 hours post-operatively 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
Pain score 6 hours post-operatively 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"
Pain score 12 hours post-operatively 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"
Chronic pain 3 months after operation 3 months post-operatively 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.
satisfaction from post-operative analgesia 48 hours post-operatively satisfaction from post-operative analgesia on a four-point Likert scale with 1 marked as minimal satisfaction and 4 as maximal satisfaction
Patient agitation- sedation status in the first 6 hours 6 hours post-operatively 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
Patient agitation- sedation status in the first 48 hours 48 hours post-operatively 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
Chronic pain 6 months after operation 6 months post-operatively 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.
Trial Locations
- Locations (2)
Aretaieion University Hospital
🇬🇷Athens, Greece
Sotiria Thoracic Diseases Hospital
🇬🇷Athens, Greece