Postoperative PainNCT05282303
REGIONAL ANALGESIA TECHNIQUES FOR EFFECTIVE RECOVERY TO CORONARY ARTERY BYPASS SURGERIES: A RETROSPECTİVE STUDY IN A SINGLE CENTER EXPERIENCE
An observational study of Postoperative Pain, run by V.K.V. American Hospital, Istanbul at 1 site in Turkey (Türkiye).
Trial summary
Background Pain after cardiac surgery is both multifocal and multifactorial. Sternotomy, sternal retraction, internal mammary dissection, posterior rib dislocation or fracture, possible brachial plexus injury, and mediastinal and pleural drains contribute to pain experienced in the immediate postoperative period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- CABG operation
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 221 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2020to 20 Jan 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with coronary artery disease scheduled for bypass surgery
Who may be able to join
- Who underwent coronary artery bypass grafting (CABG) surgery at the VKV American Hospital between January 2015 and May 2020 were reviewed retrospectively
Who cannot join
- History of cerebrovascular event
- History of Alzheimer's and dementia
- Inadequate cognitive functions
- History of chronic pain
- Long-term opioid therapy
Trial locations and contacts
1 site in 1 country.
About this study
Background Pain after cardiac surgery is both multifocal and multifactorial. Sternotomy, sternal retraction, internal mammary dissection, posterior rib dislocation or fracture, possible brachial plexus injury, and mediastinal and pleural drains contribute to pain experienced in the immediate postoperative period. Ineffective pain management can cause systemic and pulmonary complications and significant cardiac consequences.
Methods This study was conducted to compare the effectiveness of regional anesthesia techniques for perioperative pain management in cardiac surgery patients at our clinic. The effects of analgesic methods, in terms of contributing to recovery, have been examined.
Read the detailed description
This study was approved by the Koç University Clinical Research Ethics Committee (2021.464.IRB1.131); patients who underwent coronary artery bypass grafting (CABG) surgery at the VKV American Hospital between January 2015 and May 2020 were reviewed retrospectively. Patients with a history of cerebrovascular events, scheduled carotid surgery, or emergency CABG surgery were excluded from the study. Demographic data from the preoperative evaluation forms and operation types from the surgery reports were recorded. Intraoperative anesthesia follow-up forms were assessed if regional anesthesia was used, and the type and extent of opioids during the operation were examined. The postoperative transfer forms were examined to the cardiovascular intensive care unit (CICU), intensive care follow-up forms, and service ward record follow-up forms. Pain scores (NRS) during rest and coughing, vital signs, mobilization, and the start of respiratory exercises were recorded for postoperative respiratory complications.
- Conditions
- Postoperative Pain
- Being tested
- CABG operation
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CABG operationProcedure or surgery
Efficacy of regional analgesia techniques in coronary artery bypass operations
| Study group | Role | What they receive |
|---|---|---|
| DIESPB | Dual injection of erector spinae plane block Receives: Procedure: CABG operation | |
| TPVB | Thoracic paravertebral block Receives: Procedure: CABG operation | |
| SAB | Serratus anterior plane block Receives: Procedure: CABG operation | |
| PIB | Parasternal ıntercostal block Receives: Procedure: CABG operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative analgesia
NRS score
Measured: 0 - 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start10 Jul 2020
- Primary completion1 Jan 2021
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- V.K.V. American Hospital, Istanbul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sami Kaan Coşarcan, V.K.V. American Hospital, Istanbul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282303
- Sponsor's protocol ID
- Cosarcan3
- Status last verified
- Mar 2022
- First submitted
- 25 Feb 2022
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bigeleisen PE, Goehner N. Novel approaches in pain management in cardiac surgery. Curr Opin Anaesthesiol. 2015 Feb;28(1):89-94. doi: 10.1097/ACO.0000000000000147.
PubMed 25500688Doehring A, Oertel BG, Sittl R, Lotsch J. Chronic opioid use is associated with increased DNA methylation correlating with increased clinical pain. Pain. 2013 Jan;154(1):15-23. doi: 10.1016/j.pain.2012.06.011.
PubMed 23273101Nagaraja PS, Ragavendran S, Singh NG, Asai O, Bhavya G, Manjunath N, Rajesh K. Comparison of continuous thoracic epidural analgesia with bilateral erector spinae plane block for perioperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):323-327. doi: 10.4103/aca.ACA_16_18.
PubMed 30052229Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153.
PubMed 31054241Elsharkawy H, Pawa A, Mariano ER. Interfascial Plane Blocks: Back to Basics. Reg Anesth Pain Med. 2018 May;43(4):341-346. doi: 10.1097/AAP.0000000000000750.
PubMed 29561295
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REGIONAL ANALGESIA TECHNIQUES FOR EFFECTIVE RECOVERY TO CORONARY ARTERY BYPASS SURGERIES: A RETROSPECTİVE STUDY IN A SINGLE CENTER EXPERIENCE
- ClinicalTrials.gov ID
- NCT05282303
- Acronym / sponsor ID
- Cosarcan3
- Conditions
- Postoperative Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- V.K.V. American Hospital, IstanbulUniversity, hospital or other
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 16 Mar 2022 (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.
Background Pain after cardiac surgery is both multifocal and multifactorial. Sternotomy, sternal retraction, internal mammary dissection, posterior rib dislocation or fracture, possible brachial plexus injury, and mediastinal and pleural drains contribute to pain experienced in the immediate postoperative period. Ineffective pain management can cause systemic and pulmonary complications and significant cardiac consequences.
Methods This study was conducted to compare the effectiveness of regional anesthesia techniques for perioperative pain management in cardiac surgery patients at our clinic. The effects of analgesic methods, in terms of contributing to recovery, have been examined.
Detailed description
This study was approved by the Koç University Clinical Research Ethics Committee (2021.464.IRB1.131); patients who underwent coronary artery bypass grafting (CABG) surgery at the VKV American Hospital between January 2015 and May 2020 were reviewed retrospectively. Patients with a history of cerebrovascular events, scheduled carotid surgery, or emergency CABG surgery were excluded from the study. Demographic data from the preoperative evaluation forms and operation types from the surgery reports were recorded. Intraoperative anesthesia follow-up forms were assessed if regional anesthesia was used, and the type and extent of opioids during the operation were examined. The postoperative transfer forms were examined to the cardiovascular intensive care unit (CICU), intensive care follow-up forms, and service ward record follow-up forms. Pain scores (NRS) during rest and coughing, vital signs, mobilization, and the start of respiratory exercises were recorded for postoperative respiratory complications.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DIESPB | – | Procedure: CABG operationDual injection of erector spinae plane block |
| TPVB | – | Procedure: CABG operationThoracic paravertebral block |
| SAB | – | Procedure: CABG operationSerratus anterior plane block |
| PIB | – | Procedure: CABG operationParasternal ıntercostal block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary artery disease scheduled for bypass surgery
Key inclusion criteria (1 listed)
- Who underwent coronary artery bypass grafting (CABG) surgery at the VKV American Hospital between January 2015 and May 2020 were reviewed retrospectively
Key exclusion criteria (5 listed)
- History of cerebrovascular event
- History of Alzheimer's and dementia
- Inadequate cognitive functions
- History of chronic pain
- Long-term opioid therapy
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 |
|---|---|---|
| CABG operationEfficacy of regional analgesia techniques in coronary artery bypass operations | Procedure or surgery | DIESPB, PIB, SAB, TPVB |
Primary outcome
Postoperative analgesia
Time frame: 0 - 24 hours
NRS score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Results publication: PubMed 25500688Bigeleisen PE, Goehner N. Novel approaches in pain management in cardiac surgery. Curr Opin Anaesthesiol. 2015 Feb;28(1):89-94. doi: 10.1097/ACO.0000000000000147.
- Results publication: PubMed 23273101Doehring A, Oertel BG, Sittl R, Lotsch J. Chronic opioid use is associated with increased DNA methylation correlating with increased clinical pain. Pain. 2013 Jan;154(1):15-23. doi: 10.1016/j.pain.2012.06.011.
- Results publication: PubMed 30052229Nagaraja PS, Ragavendran S, Singh NG, Asai O, Bhavya G, Manjunath N, Rajesh K. Comparison of continuous thoracic epidural analgesia with bilateral erector spinae plane block for perioperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):323-327. doi: 10.4103/aca.ACA_16_18.
- Results publication: PubMed 31054241Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153.
- Results publication: PubMed 29561295Elsharkawy H, Pawa A, Mariano ER. Interfascial Plane Blocks: Back to Basics. Reg Anesth Pain Med. 2018 May;43(4):341-346. doi: 10.1097/AAP.0000000000000750.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by V.K.V. American Hospital, Istanbul at 1 site in Turkey (Türkiye).
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 5 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: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative analgesia (time frame: 0 - 24 hours). 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 NCT05282303, which also lists 5 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 16 Mar 2022.