Pain, PostoperativeNCT05843344
Dexmedetomidine and Morphine as Adjuvants to US Guided Erector Spinae Plane Blocks in Elective Thoracic Surgeries
A study testing erector spinae plane block with a combination of ropivacaine and morphine, erector spinae plane block with a combination of ropivacaine and dexmedetomidine and erector spinae plane block with ropivacaine only in people with Pain, Postoperative and Pain, Acute, run by Dr Kassiani Theodoraki at 2 sites in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Pain, Postoperative, Pain, Acute, Pain, Chronic
- What is being tested?
- erector spinae plane block with a combination of ropivacaine and morphine, erector spinae plane block with a combination of ropivacaine and dexmedetomidine and erector spinae plane block with ropivacaine only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesGreece
- Study dates
- 1 May 2023to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing elective thoracotomy for any cause (ASA I-III)
Who cannot join
- 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)
Show all 12Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Sotiria Thoracic Diseases Hospital
Athens, 11527
Dimitra Papadopoulou, MD, MSc, +306942466678, dim.dim.pap@gmail.com
Aretaieion University Hospital
Athens, 11528
Kassiani Theodoraki, PhD, DESA, +306974634162
About this study
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.
Read the 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.
- Conditions
- Pain, Postoperative, Pain, Acute, Pain, Chronic, Morphine, Dexmedetomidine, Analgesia
- Being tested
- 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
- Medical subject headings
- Pain, Postoperative, Acute Pain, Chronic Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erector spinae plane block with a combination of ropivacaine and morphineDrug
Also called ropivacaine plus 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
erector spinae plane block with a combination of ropivacaine and dexmedetomidineDrug
Also called ropivacaine plus 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
erector spinae plane block with ropivacaine onlyDrug
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| ropivacaine and morphine group | Active comparator | erector spinae plane block with a combination of ropivacaine and morphine Receives: Drug: erector spinae plane block with a combination of ropivacaine and morphine |
| ropivacaine and dexmedetomidine group | Active comparator | erector spinae plane block with a combination of ropivacaine and dexmedetomidine Receives: Drug: erector spinae plane block with a combination of ropivacaine and dexmedetomidine |
| ropivacaine group | Active comparator | erector spinae plane block with ropivacaine only Receives: Drug: erector spinae plane block with ropivacaine only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours post-operatively
Secondary outcomes (23)
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.
Measured: 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.
Measured: 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.
Measured: 24 hours post-operatively
Intraoperative remifentanil consumption
intraoperative remifentanil consumption will be monitored according to nociception level (NOL) index
Measured: Duration of operation
Intraoperative morphine consumption
Intraoperative morphine consumption will be monitored according to nociception level (NOL) index
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 48 hours post-operatively
side effects post-operatively
patients will be monitored for any side effects post-operatively
Measured: 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
Measured: 48 hours post-operatively
time to first request of analgesia
the time for the first patient for analgesia will be noted
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 48 hours post-operatively
Nausea and vomiting
Incidence of nausea and vomiting will be monitored for the first 24 hours postoperatively
Measured: 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.
Measured: 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.
Measured: 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
Measured: 48hours post-operatively
Post-operative Delirium (POD) Incidence
Incidence of POD will be assessed
Measured: 48 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 May 2023 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Kassiani Theodoraki
- Sponsor type
- University, hospital or other
- Collaborators
- Sotiria General Hospital
- Responsible party
- Sponsor-investigator, Dr Kassiani Theodoraki, Aretaieion University Hospital
- Investigators
- Kassiani Theodoraki, PhD, DESA, Principal investigator, Aretaieion UNiversity Hospital, National and Kapodistrin University of Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843344
- Sponsor's protocol ID
- 492/15-03-2023
- Status last verified
- May 2023
- First submitted
- 12 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007.
PubMed 18456219A Mesbah, MB BCh FCAI FRCA, J Yeung, MB ChB FRCA PhD FFICM, F Gao, MB BS PhD MPhil FRCA MD FFICM, Pain after thoracotomy, BJA Education, Volume 16, Issue 1, January 2016, Pages 1-7, https://doi.org/10.1093/bjaceaccp/mkv005
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.
PubMed 24901240Yeung JH, Gates S, Naidu BV, Wilson MJ, Gao Smith F. Paravertebral block versus thoracic epidural for patients undergoing thoracotomy. Cochrane Database Syst Rev. 2016 Feb 21;2(2):CD009121. doi: 10.1002/14651858.CD009121.pub2.
PubMed 26897642Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016Kot P, Rodriguez P, Granell M, Cano B, Rovira L, Morales J, Broseta A, Andres J. The erector spinae plane block: a narrative review. Korean J Anesthesiol. 2019 Jun;72(3):209-220. doi: 10.4097/kja.d.19.00012. Epub 2019 Mar 19.
PubMed 30886130Hassan ME, Wadod MAA. Serratus anterior plane block and erector spinae plane block in postoperative analgesia in thoracotomy: A randomised controlled study. Indian J Anaesth. 2022 Feb;66(2):119-125. doi: 10.4103/ija.ija_257_21. Epub 2022 Feb 24.
PubMed 35359482Hamed MA, Fargaly OS, Abdelghaffar RA, Moussa MA, Algyar MF. The role of dexmedetomidine as an adjuvant for high-thoracic erector spinae plane block for analgesia in shoulder arthroscopy; a randomized controlled study. BMC Anesthesiol. 2023 Feb 15;23(1):53. doi: 10.1186/s12871-023-02014-2.
PubMed 36793000Gao Z, Xiao Y, Wang Q, Li Y. Comparison of dexmedetomidine and dexamethasone as adjuvant for ropivacaine in ultrasound-guided erector spinae plane block for video-assisted thoracoscopic lobectomy surgery: a randomized, double-blind, placebo-controlled trial. Ann Transl Med. 2019 Nov;7(22):668. doi: 10.21037/atm.2019.10.74.
PubMed 31930069Ling L, Yang TX, Lee SWK. Effect of Anaesthesia Depth on Postoperative Delirium and Postoperative Cognitive Dysfunction in High-Risk Patients: A Systematic Review and Meta-Analysis. Cureus. 2022 Oct 10;14(10):e30120. doi: 10.7759/cureus.30120. eCollection 2022 Oct.
PubMed 36381936Suraarunsumrit P, Pathonsmith C, Srinonprasert V, Sangarunakul N, Jiraphorncharas C, Siriussawakul A. Postoperative cognitive dysfunction in older surgical patients associated with increased healthcare utilization: a prospective study from an upper-middle-income country. BMC Geriatr. 2022 Mar 16;22(1):213. doi: 10.1186/s12877-022-02873-3.
PubMed 35296258
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine and Morphine as Adjuvants to US Guided Erector Spinae Plane Blocks in Elective Thoracic Surgeries
- ClinicalTrials.gov ID
- NCT05843344
- Acronym / sponsor ID
- 492/15-03-2023
- Conditions
- Pain, Postoperative, Pain, Acute, Pain, Chronic, Morphine, Dexmedetomidine, Analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Dr Kassiani TheodorakiUniversity, hospital or other
- Collaborators
- Sotiria General Hospital
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ropivacaine and morphine group | Active comparator | Drug: erector spinae plane block with a combination of ropivacaine and morphineerector spinae plane block with a combination of ropivacaine and morphine |
| ropivacaine and dexmedetomidine group | Active comparator | Drug: erector spinae plane block with a combination of ropivacaine and dexmedetomidineerector spinae plane block with a combination of ropivacaine and dexmedetomidine |
| ropivacaine group | Active comparator | Drug: erector spinae plane block with ropivacaine onlyerector spinae plane block with ropivacaine only |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing elective thoracotomy for any cause (ASA I-III)
Key exclusion criteria (12 listed)
- known allergy to local anesthetic
- local inflammation
- severe respiratory distress ( breathing dependence on accessory muscles)
- severe spinal deformities
- severe ipsilateral diaphragmatic paresis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| erector spinae plane block with a combination of ropivacaine and morphineAlso: ropivacaine plus morphineBefore 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 | Drug | ropivacaine and morphine group |
| erector spinae plane block with a combination of ropivacaine and dexmedetomidineAlso: ropivacaine plus dexmedetomidineBefore 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 | Drug | ropivacaine and dexmedetomidine group |
| erector spinae plane block with ropivacaine onlyAlso: ropivacaine onlyBefore 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 | Drug | ropivacaine group |
Primary outcome
Intravenous morphine consumption in the first 48 hours post-operatively
Time frame: 48 hours post-operatively
Patients will be tracked for cumulative morphine consumption through a patient controlled analgesia device for the first 48 hours.
23 secondary outcomes
IV morphine consumption in the first 6 hours
Time frame: 6 hours post-operatively
IV morphine consumption in the first 12 hours
Time frame: 12 hours post-operatively
IV morphine consumption in the first 24 hours
Time frame: 24 hours post-operatively
Intraoperative remifentanil consumption
Time frame: Duration of operation
Intraoperative morphine consumption
Time frame: Duration of operation
Pain score after surgery (PACU)
Time frame: immediately post-operatively
Pain score 6 hours post-operatively
Time frame: 6 hours post-operatively
Pain score 12 hours post-operatively
Time frame: 12 hours post-operatively
Pain score 24 hours post-operatively
Time frame: 24 hours post-operatively
Pain score 48 hours post-operatively
Time frame: 48 hours post-operatively
side effects post-operatively
Time frame: 48 hours post-operatively
satisfaction from post-operative analgesia
Time frame: 48 hours post-operatively
time to first request of analgesia
Time frame: 48 hours post-operatively
Patient agitation- sedation status post-operatively (PACU)
Time frame: Immediately post-operatively
Patient agitation- sedation status in the first 6 hours
Time frame: 6 hours post-operatively
Patient agitation- sedation status in the first 12 hours
Time frame: 12 hours post-operatively
Patient agitation- sedation status in the first 24 hours
Time frame: 24 hours post-operatively
Patient agitation- sedation status in the first 48 hours
Time frame: 48 hours post-operatively
Nausea and vomiting
Time frame: 24 hours post-operatively
Chronic pain 3 months after operation
Time frame: 3 months post-operatively
Chronic pain 6 months after operation
Time frame: 6 months post-operatively
Post-operative cognitive disorder (POCD)
Time frame: 48hours post-operatively
Post-operative Delirium (POD) Incidence
Time frame: 48 hours post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Background: PubMed 18456219Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007.
- BackgroundA Mesbah, MB BCh FCAI FRCA, J Yeung, MB ChB FRCA PhD FFICM, F Gao, MB BS PhD MPhil FRCA MD FFICM, Pain after thoracotomy, BJA Education, Volume 16, Issue 1, January 2016, Pages 1-7, https://doi.org/10.1093/bjaceaccp/mkv005
- Background: PubMed 24901240Mazo 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.
- Background: PubMed 26897642Yeung JH, Gates S, Naidu BV, Wilson MJ, Gao Smith F. Paravertebral block versus thoracic epidural for patients undergoing thoracotomy. Cochrane Database Syst Rev. 2016 Feb 21;2(2):CD009121. doi: 10.1002/14651858.CD009121.pub2.
- Background: PubMed 27501016Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- Background: PubMed 30886130Kot P, Rodriguez P, Granell M, Cano B, Rovira L, Morales J, Broseta A, Andres J. The erector spinae plane block: a narrative review. Korean J Anesthesiol. 2019 Jun;72(3):209-220. doi: 10.4097/kja.d.19.00012. Epub 2019 Mar 19.
- Background: PubMed 35359482Hassan ME, Wadod MAA. Serratus anterior plane block and erector spinae plane block in postoperative analgesia in thoracotomy: A randomised controlled study. Indian J Anaesth. 2022 Feb;66(2):119-125. doi: 10.4103/ija.ija_257_21. Epub 2022 Feb 24.
- Background: PubMed 36793000Hamed MA, Fargaly OS, Abdelghaffar RA, Moussa MA, Algyar MF. The role of dexmedetomidine as an adjuvant for high-thoracic erector spinae plane block for analgesia in shoulder arthroscopy; a randomized controlled study. BMC Anesthesiol. 2023 Feb 15;23(1):53. doi: 10.1186/s12871-023-02014-2.
- Background: PubMed 31930069Gao Z, Xiao Y, Wang Q, Li Y. Comparison of dexmedetomidine and dexamethasone as adjuvant for ropivacaine in ultrasound-guided erector spinae plane block for video-assisted thoracoscopic lobectomy surgery: a randomized, double-blind, placebo-controlled trial. Ann Transl Med. 2019 Nov;7(22):668. doi: 10.21037/atm.2019.10.74.
- Background: PubMed 36381936Ling L, Yang TX, Lee SWK. Effect of Anaesthesia Depth on Postoperative Delirium and Postoperative Cognitive Dysfunction in High-Risk Patients: A Systematic Review and Meta-Analysis. Cureus. 2022 Oct 10;14(10):e30120. doi: 10.7759/cureus.30120. eCollection 2022 Oct.
- Background: PubMed 35296258Suraarunsumrit P, Pathonsmith C, Srinonprasert V, Sangarunakul N, Jiraphorncharas C, Siriussawakul A. Postoperative cognitive dysfunction in older surgical patients associated with increased healthcare utilization: a prospective study from an upper-middle-income country. BMC Geriatr. 2022 Mar 16;22(1):213. doi: 10.1186/s12877-022-02873-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kassiani Theodoraki, PhD, DESA principal investigator
Aretaieion UNiversity Hospital, National and Kapodistrin University of Athens, Greece
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing erector spinae plane block with a combination of ropivacaine and morphine, erector spinae plane block with a combination of ropivacaine and dexmedetomidine and erector spinae plane block with ropivacaine only in people with Pain, Postoperative and Pain, Acute, run by Dr Kassiani Theodoraki at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kassiani Theodoraki, PhD DESA (+306974634162, ktheodoraki@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intravenous morphine consumption in the first 48 hours post-operatively (time frame: 48 hours post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05843344, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.