Chronic PainNCT06315959
Bilateral Erector Spinae Plane Block for Postoperative Chronic Pain After Open Heart Surgery
A study testing Bilateral ultrasound guided erector spinae plane block and morphine PCA in people with Chronic Pain and Cardiac Surgery, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effect of bilateral erector spinae plane (ESP) block application on postoperative chronic pain in patients undergoing on-pump open-heart surgery. At 3 months post-discharge, patients will be contacted by phone to assess their chronic pain status. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Pain, Cardiac Surgery, Post Operative Pain
- What is being tested?
- Bilateral ultrasound guided erector spinae plane block and morphine PCA
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 20 Feb 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-80 undergoing elective on-pump open-heart surgery via median sternotomy.
- American Society of Anesthesiologists (ASA)classification II-III patients.
- Patients who can use PCA.
- Patients who will sign the informed consent form.
Who cannot join
- History of opioid use for more than four weeks
- Chronic pain syndromes
- Patients with a history of local anesthetic or opioid allergy, hypersensitivity
- Alcohol and drug addiction
- Conditions where regional anesthesia is contraindicated
- Failure in the dermatomal examination performed after the block
Show all 14Show fewer
- Emergency surgeries and redo surgeries.
- Individuals with obstructive sleep apnea.
- Left ventricular ejection fraction less than 30%.
- Patients with severe psychiatric illnesses (such as psychosis, dementia) that limit cooperation with verbal numerical pain scales.
- Pregnant and breastfeeding patients.
- Hematological disorders.
- Significant impairment in the function of a major organ (e.g., severe hepatic or renal disease).
- Patients who cannot be extubated within the first 6 hours postoperatively.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayis University
Samsun, Atakum, 55139
About this study
Official title: Bilateral Ultrasound-guided Erector Spinae Plane Block for Postoperative Chronic Pain Following Open Heart Surgery: A Prospective Randomized Controlled Trial
The aim of this study is to investigate the effect of bilateral erector spinae plane (ESP) block application on postoperative chronic pain in patients undergoing on-pump open-heart surgery. At 3 months post-discharge, patients will be contacted by phone to assess their chronic pain status. Pain intensity and status will be evaluated using the Brief Pain Inventory, and the character of pain will be assessed using the Douleur Neuropathique 4 (DN4) score. Additionally, the patient's anxiety and depression status will be evaluated using the Hospital Anxiety and Depression Scale.
Read the detailed description
Acute or chronic pain following cardiac surgery is a common issue that significantly impacts quality of life. The reported incidence of moderate to severe acute pain post-cardiac surgery varies widely in the literature, ranging from less than 5% to over 80%. Factors contributing to severe postoperative pain after median sternotomy include vasospasm, increased inflammatory response, soft tissue and bone injury during dissection, and chest tube placement. While pain typically decreases after the first 24 hours post-surgery, inadequate pain management can prolong this period. Chronic pain syndrome following sternotomy has been reported in 7% to 66% of patients undergoing open-heart surgery.
Initially, neuraxial anesthesia techniques such as thoracic epidural or thoracic paravertebral blocks were recommended for postoperative pain control in minimally invasive cardiac surgery. However, debates exist due to technical and patient-related challenges such as procedural difficulties, coagulation disorders, complete heparinization, hemodynamic instability, and pneumothorax. Fascial plane chest wall blocks involving serratus anterior and erector spinae have gained popularity for managing postoperative pain after minimally invasive cardiac surgery and thoracotomy/sternotomy, especially in patients receiving antiplatelet and anticoagulant therapy. An alternative approach, ultrasound-guided erector spinae plane block (ESPB), was introduced by Forero and colleagues in 2016 for treating thoracic neuropathic pain.
Inadequate pain control post-surgery can lead to persistent postoperative pain, high opioid consumption, and opioid-related morbidity. Theoretically, in patients receiving an erector spinae plane (ESP) block, the local anesthetic spreads both cranio-caudally and anteriorly through the costotransverse foramina, blocking the ventral/dorsal branches of spinal nerves, dorsal root ganglion, and rami communicantes at multiple levels. In patients undergoing sternotomy for cardiac surgery, bilateral thoracic ESP catheters or a single injection technique have reduced opioid use and pain scores.
This study is planned as a prospective, randomized controlled, double-blind, parallel-group trial.
Patients will be divided into two groups:
ESP Group: General anesthesia + ESP Block + Patient-Controlled Analgesia (PCA) Group K: General anesthesia + PCA
- Conditions
- Chronic Pain, Cardiac Surgery, Post Operative Pain
- Being tested
- Bilateral ultrasound guided erector spinae plane block, morphine PCA, Control group
- Keywords
- Chronic Pain, Cardiac surgery, Erector Spinae Plane Block
- Medical subject headings
- Chronic Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral ultrasound guided erector spinae plane blockProcedure or surgery
Also called erector spinae plane block
Bilateral ultrasound-guided ESP(total of 60 ml, %0.25 bupivacaine) will be performed + IV morphine PCA Multimodal analgesia : Intraoperatively, all patients will receive 0.05 mg/kg (IBW) iv morphine. Thirty minutes before the end of surgery, 1 gram of intravenous paracetamol will be administered. Postoperative analgesia: iv paracetamol 1gr every 8 hours and IV PCA of 0,5mg/ml morphine. In cases where rescue analgesia is required (NRS score ≥4),iv fentanyl 25-50 mcg and/or ibuprofen and/or ketamine 10 mg will be administered. Patients are routinely administered iv dexamethasone 4 mg and IV 8 mg ondansetron 20 minutes before end of surgery for postoperative nausea and vomiting prophylaxis.
Postoperative chronic pain will be assessed using the Brief Pain Inventory(BPI).
Anxiety and depression status will be evaluated using the Hospital Anxiety and Depression Scale (HADS).
The character of pain will be evaluated using the Douleur Neuropathique 4 (DN4) score.
morphine PCADrug
Also called PCA
IV PCA of 0,5mg/ml morphine (the bolus dose is 20 µg/kg, the lock-in time of 6-10 minutes, the 4-hour limit is adjusted to be 80% of the calculated total amount).
Control groupOther
Also called control
Patients in this group will not be performed plane blocks. Multimodal analgesia : Intraoperatively, all patients will receive 0.05 mg/kg (IBW) iv morphine. Thirty minutes before the end of surgery, 1 gram of intravenous paracetamol will be administered. Postoperative analgesia: iv paracetamol 1gr every 8 hours and IV PCA of 0,5mg/ml morphine. In cases where rescue analgesia is required (NRS score ≥4),iv fentanyl 25-50 mcg and/or ibuprofen and/or ketamine 10 mg will be administered. Patients are routinely administered iv dexamethasone 4 mg and IV 8 mg ondansetron 20 minutes before end of surgery for postoperative nausea and vomiting prophylaxis.
Postoperative chronic pain will be assessed using the Brief Pain Inventory(BPI).
Anxiety and depression status will be evaluated using the Hospital Anxiety and Depression Scale (HADS) .
The character of pain will be evaluated using the Douleur Neuropathique 4 (DN4) score.
morphine PCADrug
Also called PCA
V PCA of 0,5mg/ml morphine (the bolus dose is 20 µg/kg, the lock-in time of 6-10 minutes, the 4-hour limit is adjusted to be 80% of the calculated total amount).
| Study group | Role | What they receive |
|---|---|---|
| Group ESP | Active comparator | A bilateral ESP Block(60 ml, %0.25 bupivacaine, totally) + IV morphine patient-controlled analgesia (PCA) Receives: Procedure: Bilateral ultrasound guided erector spinae plane block; Drug: morphine PCA |
| Group Control | Other | IV morphine PCA Receives: Other: Control group; Drug: morphine PCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic pain status
After patients are discharged, they will be contacted by phone at 3 months. Pain intensity and status will be assessed using the BPI, and the character of pain will be evaluated using the DN4 score.
Measured: Postoperative 3rd month
Secondary outcomes (8)
Postoperative opioid consumption in the first 24 Hours
Morphine consumption in the first 24 hours will be measured. Patients will be able to request opioids via a PCA device when their NRS score ≥4
Measured: Postoperative day 1
Postoperative pain scores
Pain at rest and while coughing will be assessed by numerical rating scale (NRS) scores at 0, 3, 6, 12, 18, and 24 hours after extubation. The NRS is an 11-point numeric scale that ranges from 0 to 10. The NRS is an 11-point scale consisting of integers from 0 to 10: 0 indicates "no pain" and 10 indicates "the worst pain ever possible." One day before the surgery, all patients will be informed about NRS and instructed on how to use a patient-controlled analgesia device.
Measured: Postoperative day 1
The incidences of post-operative nausea and vomiting (PONV)
The severity of postoperative nausea and vomiting (PONV) will be assessed using a descriptive verbal rating scale at 0, 3, 6, 12, 18, and 24 hours after extubation. If a score of 3 or more ondansetron 4 mg IV will be administered and will repeat after 8 hours if required.The PONV scale is 0 = no nausea; 1 = slight nausea; 2 = moderate nausea; 3 = vomiting once; and 4 = vomiting more than once.
Measured: Postoperative day 1
The number of patient requiring rescue analgesic
The number of patients who required rescue analgesics will be recorded at 0, 3, 6, 12, 18, and 24 hours after extubation
Measured: Postoperative day 1
Time to extubation
After the operation, the time until the patient is extubated will be recorded.
Measured: Postoperative day 1
The number of patients with complications
The number of patients have any complications -directly related to the block or the drug used in the block- will be recorded.
Measured: Postoperative 7 days on an average
Chronic pain status at 6 months.
After discharge, patients will be contacted by phone at 6 months. Pain intensity and status will be assessed using the Brief Pain Inventory, and the character of pain will be evaluated using the Douleur Neuropathique 4 (DN4) score. Additionally, the patient's anxiety and depression status will be assessed using the Hospital Anxiety and Depression Scale.
Measured: Postoperative 6th month
Length of stay in the ICU
Total duration of stay in ICU will be recorded.
Measured: The time from admission to the ICU to the time of discharge to the hospital ward; during the hospital stay, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 Apr 2024
- Primary completion1 Nov 2024
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A block randomization list will be created by a doctor who does not participate in patient follow-up using a web-based program, 'Research Randomizer (Urbaniak and Plous, 2013)'.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BURHAN DOST, Ondokuz Mayıs University
- Investigators
- Burhan Dost, Study director, : Ondokuz Mayis Universitesi, Samsun, Atakum 55139
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315959
- Sponsor's protocol ID
- ESPCHRONIC2023
- Status last verified
- Apr 2024
- First submitted
- 12 Mar 2024
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Ultrasound-guided Erector Spinae Plane Block for Postoperative Chronic Pain Following Open Heart Surgery: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06315959
- Acronym / sponsor ID
- ESPCHRONIC2023
- Conditions
- Chronic Pain, Cardiac Surgery, Post Operative Pain
- Keywords
- Chronic Pain, Cardiac surgery, Erector Spinae Plane Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 18 Mar 2024 (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 is to investigate the effect of bilateral erector spinae plane (ESP) block application on postoperative chronic pain in patients undergoing on-pump open-heart surgery. At 3 months post-discharge, patients will be contacted by phone to assess their chronic pain status. Pain intensity and status will be evaluated using the Brief Pain Inventory, and the character of pain will be assessed using the Douleur Neuropathique 4 (DN4) score. Additionally, the patient's anxiety and depression status will be evaluated using the Hospital Anxiety and Depression Scale.
Detailed description
Acute or chronic pain following cardiac surgery is a common issue that significantly impacts quality of life. The reported incidence of moderate to severe acute pain post-cardiac surgery varies widely in the literature, ranging from less than 5% to over 80%. Factors contributing to severe postoperative pain after median sternotomy include vasospasm, increased inflammatory response, soft tissue and bone injury during dissection, and chest tube placement. While pain typically decreases after the first 24 hours post-surgery, inadequate pain management can prolong this period. Chronic pain syndrome following sternotomy has been reported in 7% to 66% of patients undergoing open-heart surgery.
Initially, neuraxial anesthesia techniques such as thoracic epidural or thoracic paravertebral blocks were recommended for postoperative pain control in minimally invasive cardiac surgery. However, debates exist due to technical and patient-related challenges such as procedural difficulties, coagulation disorders, complete heparinization, hemodynamic instability, and pneumothorax. Fascial plane chest wall blocks involving serratus anterior and erector spinae have gained popularity for managing postoperative pain after minimally invasive cardiac surgery and thoracotomy/sternotomy, especially in patients receiving antiplatelet and anticoagulant therapy. An alternative approach, ultrasound-guided erector spinae plane block (ESPB), was introduced by Forero and colleagues in 2016 for treating thoracic neuropathic pain.
Inadequate pain control post-surgery can lead to persistent postoperative pain, high opioid consumption, and opioid-related morbidity. Theoretically, in patients receiving an erector spinae plane (ESP) block, the local anesthetic spreads both cranio-caudally and anteriorly through the costotransverse foramina, blocking the ventral/dorsal branches of spinal nerves, dorsal root ganglion, and rami communicantes at multiple levels. In patients undergoing sternotomy for cardiac surgery, bilateral thoracic ESP catheters or a single injection technique have reduced opioid use and pain scores.
This study is planned as a prospective, randomized controlled, double-blind, parallel-group trial.
Patients will be divided into two groups:
ESP Group: General anesthesia + ESP Block + Patient-Controlled Analgesia (PCA) Group K: General anesthesia + PCA
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A block randomization list will be created by a doctor who does not participate in patient follow-up using a web-based program, 'Research Randomizer (Urbaniak and Plous, 2013)'.
| Arm | Type | Receives |
|---|---|---|
| Group ESP | Active comparator | Procedure: Bilateral ultrasound guided erector spinae plane block, Drug: morphine PCAA bilateral ESP Block(60 ml, %0.25 bupivacaine, totally) + IV morphine patient-controlled analgesia (PCA) |
| Group Control | Other | Other: Control group, Drug: morphine PCAIV morphine PCA |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18-80 undergoing elective on-pump open-heart surgery via median sternotomy.
- American Society of Anesthesiologists (ASA)classification II-III patients.
- Patients who can use PCA.
- Patients who will sign the informed consent form.
Key exclusion criteria (14 listed)
- History of opioid use for more than four weeks
- Chronic pain syndromes
- Patients with a history of local anesthetic or opioid allergy, hypersensitivity
- Alcohol and drug addiction
- Conditions where regional anesthesia is contraindicated
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 |
|---|---|---|
| Bilateral ultrasound guided erector spinae plane blockAlso: erector spinae plane blockBilateral ultrasound-guided ESP(total of 60 ml, %0.25 bupivacaine) will be performed + IV morphine PCA Multimodal analgesia : Intraoperatively, all patients will receive 0.05 mg/kg (IBW) iv morphine. Thirty minutes before the end of surgery, 1 gram of intravenous paracetamol will be administered. Postoperative analgesia: iv paracetamol 1gr every 8 hours and IV PCA of 0,5mg/ml morphine. In cases where rescue analgesia is required (NRS score ≥4),iv fentanyl 25-50 mcg and/or ibuprofen and/or ketamine 10 mg will be administered. Patients are routinely administered iv dexamethasone 4 mg and IV 8 mg ondansetron 20 minutes before end of surgery for postoperative nausea and vomiting prophylaxis. Postoperative chronic pain will be assessed using the Brief Pain Inventory(BPI). Anxiety and depression status will be evaluated using the Hospital Anxiety and Depression Scale (HADS). The character of pain will be evaluated using the Douleur Neuropathique 4 (DN4) score. | Procedure or surgery | Group ESP |
| morphine PCAAlso: PCAIV PCA of 0,5mg/ml morphine (the bolus dose is 20 µg/kg, the lock-in time of 6-10 minutes, the 4-hour limit is adjusted to be 80% of the calculated total amount). | Drug | Group ESP |
| Control groupAlso: controlPatients in this group will not be performed plane blocks. Multimodal analgesia : Intraoperatively, all patients will receive 0.05 mg/kg (IBW) iv morphine. Thirty minutes before the end of surgery, 1 gram of intravenous paracetamol will be administered. Postoperative analgesia: iv paracetamol 1gr every 8 hours and IV PCA of 0,5mg/ml morphine. In cases where rescue analgesia is required (NRS score ≥4),iv fentanyl 25-50 mcg and/or ibuprofen and/or ketamine 10 mg will be administered. Patients are routinely administered iv dexamethasone 4 mg and IV 8 mg ondansetron 20 minutes before end of surgery for postoperative nausea and vomiting prophylaxis. Postoperative chronic pain will be assessed using the Brief Pain Inventory(BPI). Anxiety and depression status will be evaluated using the Hospital Anxiety and Depression Scale (HADS) . The character of pain will be evaluated using the Douleur Neuropathique 4 (DN4) score. | Other | Group Control |
| morphine PCAAlso: PCAV PCA of 0,5mg/ml morphine (the bolus dose is 20 µg/kg, the lock-in time of 6-10 minutes, the 4-hour limit is adjusted to be 80% of the calculated total amount). | Drug | Group Control |
Primary outcome
Chronic pain status
Time frame: Postoperative 3rd month
After patients are discharged, they will be contacted by phone at 3 months. Pain intensity and status will be assessed using the BPI, and the character of pain will be evaluated using the DN4 score.
8 secondary outcomes
Postoperative opioid consumption in the first 24 Hours
Time frame: Postoperative day 1
Postoperative pain scores
Time frame: Postoperative day 1
The incidences of post-operative nausea and vomiting (PONV)
Time frame: Postoperative day 1
The number of patient requiring rescue analgesic
Time frame: Postoperative day 1
Time to extubation
Time frame: Postoperative day 1
The number of patients with complications
Time frame: Postoperative 7 days on an average
Chronic pain status at 6 months.
Time frame: Postoperative 6th month
Length of stay in the ICU
Time frame: The time from admission to the ICU to the time of discharge to the hospital ward; during the hospital stay, an average of 7 days
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 24 Feb 2025.
- 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.
Burhan Dost study director
: Ondokuz Mayis Universitesi, Samsun, Atakum 55139
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral ultrasound guided erector spinae plane block and morphine PCA in people with Chronic Pain and Cardiac Surgery, run by Ondokuz Mayıs University 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 4 inclusion and 14 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 24 Feb 2025. 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?
Chronic pain status (time frame: Postoperative 3rd month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2025; AzTrials last refreshed its copy on 6 Nov 2026.