Analgesia, Dexmedetomidine, Morphine, Pain, Acute, Pain, Chronic, Pain, Postoperative
Conditions
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.
Interventions
DRUGerector 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
DRUGerector 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
DRUGerector 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
Sponsors
Sotiria General Hospital
Dr Kassiani Theodoraki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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 |
| 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 |
| 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 |
| side effects post-operatively | 48 hours post-operatively | patients will be monitored for any side effects post-operatively |
| 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 |
| 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. |
| 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 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 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 |
| 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 |
| 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 |
| Nausea and vomiting | 24 hours post-operatively | Incidence of nausea and vomiting will be monitored for the first 24 hours postoperatively |
| 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. |
| 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. |
| 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 |
| time to first request of analgesia | 48 hours post-operatively | the time for the first patient for analgesia will be noted |
Countries
Greece
Contacts
Primary ContactKassiani Theodoraki, PhD DESA
Outcome results
None listed