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

Primary Purpose

Pain, Postoperative, Pain, Acute, Pain, Chronic

Status
Not yet recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
erector spinae plane block with a combination of ropivacaine and morphine
erector spinae plane block with a combination of ropivacaine and dexmedetomidine
erector spinae plane block with ropivacaine only
Sponsored by
Dr Kassiani Theodoraki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sotiria Thoracic Diseases Hospital
  • Aretaieion University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

ropivacaine and morphine group

ropivacaine and dexmedetomidine group

ropivacaine group

Arm Description

erector spinae plane block with a combination of ropivacaine and morphine

erector spinae plane block with a combination of ropivacaine and dexmedetomidine

erector spinae plane block with ropivacaine only

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Intraoperative remifentanil consumption
intraoperative remifentanil consumption will be monitored according to nociception level (NOL) index
Intraoperative morphine consumption
Intraoperative morphine consumption will be monitored according to nociception level (NOL) index
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"
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"
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"
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"
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"
side effects post-operatively
patients will be monitored for any side effects 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 to first request of analgesia
the time for the first patient for analgesia will be noted
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
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
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
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
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
Nausea and vomiting
Incidence of nausea and vomiting will be monitored for the first 24 hours postoperatively
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.
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.
Post-operative cognitive disorder (POCD)
Incidence of POCD will be assessed using Mini-Mental State Examination (MMSE) pre-operatively and 48 hours post-operatively
Post-operative Delirium (POD) Incidence
Incidence of POD will be assessed

Full Information

First Posted
April 12, 2023
Last Updated
May 3, 2023
Sponsor
Dr Kassiani Theodoraki
Collaborators
Sotiria General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05843344
Brief Title
Dexmedetomidine and Morphine as Adjuvants to US Guided Erector Spinae Plane Blocks in Elective Thoracic Surgeries
Official Title
Dexmedetomidine and Morphine as Adjuvants to US Guided Erector Spinae Plane Blocks in Elective Thoracic Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr Kassiani Theodoraki
Collaborators
Sotiria General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Pain, Acute, Pain, Chronic, Morphine, Dexmedetomidine, Analgesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ropivacaine and morphine group
Arm Type
Active Comparator
Arm Description
erector spinae plane block with a combination of ropivacaine and morphine
Arm Title
ropivacaine and dexmedetomidine group
Arm Type
Active Comparator
Arm Description
erector spinae plane block with a combination of ropivacaine and dexmedetomidine
Arm Title
ropivacaine group
Arm Type
Active Comparator
Arm Description
erector spinae plane block with ropivacaine only
Intervention Type
Drug
Intervention Name(s)
erector spinae plane block with a combination of ropivacaine and morphine
Other Intervention Name(s)
ropivacaine plus morphine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
erector spinae plane block with a combination of ropivacaine and dexmedetomidine
Other Intervention Name(s)
ropivacaine plus dexmedetomidine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
erector spinae plane block with ropivacaine only
Other Intervention Name(s)
ropivacaine only
Intervention Description
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
Primary Outcome Measure Information:
Title
Intravenous morphine consumption in the first 48 hours post-operatively
Description
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
Secondary Outcome Measure Information:
Title
IV morphine consumption in the first 6 hours
Description
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
Title
IV morphine consumption in the first 12 hours
Description
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
Title
IV morphine consumption in the first 24 hours
Description
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
Title
Intraoperative remifentanil consumption
Description
intraoperative remifentanil consumption will be monitored according to nociception level (NOL) index
Time Frame
Duration of operation
Title
Intraoperative morphine consumption
Description
Intraoperative morphine consumption will be monitored according to nociception level (NOL) index
Time Frame
Duration of operation
Title
Pain score after surgery (PACU)
Description
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"
Time Frame
immediately post-operatively
Title
Pain score 6 hours post-operatively
Description
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
Title
Pain score 12 hours post-operatively
Description
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
Title
Pain score 24 hours post-operatively
Description
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
Title
Pain score 48 hours post-operatively
Description
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
Title
side effects post-operatively
Description
patients will be monitored for any side effects post-operatively
Time Frame
48 hours post-operatively
Title
satisfaction from post-operative analgesia
Description
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
Title
time to first request of analgesia
Description
the time for the first patient for analgesia will be noted
Time Frame
48 hours post-operatively
Title
Patient agitation- sedation status post-operatively (PACU)
Description
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
Title
Patient agitation- sedation status in the first 6 hours
Description
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
Title
Patient agitation- sedation status in the first 12 hours
Description
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
Title
Patient agitation- sedation status in the first 24 hours
Description
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
Title
Patient agitation- sedation status in the first 48 hours
Description
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
Title
Nausea and vomiting
Description
Incidence of nausea and vomiting will be monitored for the first 24 hours postoperatively
Time Frame
24 hours post-operatively
Title
Chronic pain 3 months after operation
Description
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
Title
Chronic pain 6 months after operation
Description
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
Title
Post-operative cognitive disorder (POCD)
Description
Incidence of POCD will be assessed using Mini-Mental State Examination (MMSE) pre-operatively and 48 hours post-operatively
Time Frame
48hours post-operatively
Title
Post-operative Delirium (POD) Incidence
Description
Incidence of POD will be assessed
Time Frame
48 hours post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kassiani Theodoraki, PhD DESA
Phone
+306974634162
Email
ktheodoraki@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kassiani Theodoraki, PhD, DESA
Organizational Affiliation
Aretaieion UNiversity Hospital, National and Kapodistrin University of Athens, Greece
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sotiria Thoracic Diseases Hospital
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dimitra Papadopoulou, MD, MSc
Phone
+306942466678
Email
dim.dim.pap@gmail.com
Facility Name
Aretaieion University Hospital
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kassiani Theodoraki, PhD, DESA
Phone
+306974634162

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18456219
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
24901240
Citation
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.
Results Reference
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Results Reference
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Dexmedetomidine and Morphine as Adjuvants to US Guided Erector Spinae Plane Blocks in Elective Thoracic Surgeries

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