Pain, PostoperativeNCT06098859
Thoracic Epidural Analgesia and Bilateral Erector Spinae Plane Block on Postoperative Pain in Open Heart Surgeries
A study testing Thoracic epidural analgesia and Erector spinae plane block in people with Pain, Postoperative and Respiratory Complication, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
Postoperative pain negatively effects respiratory functions in open heart surgeries. The aim of the study is to compare the effects of thoracic epidural analgesia (TEA) and erector spinae plane block (ESPB) on postoperative pain and respiratory functions in patients undergoing open heart surgery with sternotomy Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Respiratory Complication
- What is being tested?
- Thoracic epidural analgesia and Erector spinae plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2023to 15 Sep 2023
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has ASA II-IV score
- Having open heart surgery
Who cannot join
- Having a psychiatric illness
- Using analgesic medication due to chronic pain
- Uncooperative
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Thoracic Epidural Analgesia and Bilateral Erector Spinae Plane Block on Postoperative Pain and Respiratory Fonctions in Open Heart Surgeries''
Postoperative pain negatively effects respiratory functions in open heart surgeries. The aim of the study is to compare the effects of thoracic epidural analgesia (TEA) and erector spinae plane block (ESPB) on postoperative pain and respiratory functions in patients undergoing open heart surgery with sternotomy
Read the detailed description
Thoracic epidural catheter was inserted to patients in Group T at the T4-T5 vertebra level before induction of general anesthesia. And then local anesthetic infusion was started until postoperative 48. hours.
Bilateral erector spinae plan block was applied with total 40 ml of local anesthetic solution to patients in Group E at the T4-T5 vertebra level before induction of general anesthesia.
The control group was infused with 1 mcg/kg/min fentanyl during the surgery. In the postoperative period, 1 g paracetamol was infused 4 times a day.
All patients underwent general anesthesia with the same method and medications.
Tramadol/diclofenac was administered to patients with a pain score (NRS) above 4. NRS and tidal volumes (TV) of the patients were measured at 0, 2, 6, 12, 24, 36 and 48. hours after extubation. Postoperative mechanical ventilation durations, intensive care unit and hospital stays, additional analgesic needs and respiratory complications of the patients were recorded.
- Conditions
- Pain, Postoperative, Respiratory Complication
- Being tested
- Thoracic epidural analgesia, Erector spinae plane block
- Keywords
- Thoracic epidural analgesia, erector spinae plane block, heart surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic epidural analgesiaProcedure or surgery
Thoracic epidural analgesia was started preoperatively and rest posoperative 48 hours
Erector spinae plane blockProcedure or surgery
Erector spinae plane block was applied preoperatively using local anesthetic
| Study group | Role | What they receive |
|---|---|---|
| Thoracic epidural analgesia | Active comparator | Thoracic epidural analgesia have been started preoperatively and coninuoed until postoperative 48 hours Receives: Procedure: Thoracic epidural analgesia |
| Erector spinae plane block | Active comparator | Erector spinae plane blockwas applied preoperatively Receives: Procedure: Erector spinae plane block |
| Intravenous opioid analgesia | No intervention | Intravenous opioid analgesia was administered during the surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Patients were asked about their pain levels. Rating done with VRS (Verbal Rating Scale).
Pain levels were evaluated between 0 and 10 points. 0: No pain (the best)….. 10: Unbearable pain (the worst)
Measured: Postoperative 48 hours
Respiratory functions
Oxygen requirement:If more than 4 l/min oxygen support via face mask is required to maintain peripheral oxygen saturation (SpO2) above 90%, it is defined as oxygen requirement.
Tachypnea:more than 20/min
Fever: more than 37 C celcius
Non invasive mechanical ventilation requirement:To patients whose breathing is impaired after extubation (who have tachypnea and have SpO2 less than 90% despite receiving oxygen support of more than 4 l/min oxygen support via face mask)
Measured: Postoperative 48 hours
Secondary outcomes (2)
Analgesic requirement. When the VRS was more than 4 points
diclofenac (75 mg), tramadol (50mg)
Measured: Postoperative 48 hours
Intensive care and hospital stay
time for Intensive care and hospital (hours and days, respectively)
Measured: postoperative 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start10 Jan 2023
- Primary completion28 Aug 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- The effects of thoracic epidural analgesia and erector spinae plane block on postoperative pain were compared with the control group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Engin Ertürk, Karadeniz Technical University
- Investigators
- Engin Ertürk, Prof. Dr, Principal investigator, Karadeniz Technical University, Medical Faculty, Anesthesiology and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098859
- Sponsor's protocol ID
- 2023/184
- Status last verified
- Oct 2023
- First submitted
- 13 Oct 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Thoracic Epidural Analgesia and Bilateral Erector Spinae Plane Block on Postoperative Pain and Respiratory Fonctions in Open Heart Surgeries''
- ClinicalTrials.gov ID
- NCT06098859
- Acronym / sponsor ID
- 2023/184
- Conditions
- Pain, Postoperative, Respiratory Complication
- Keywords
- Thoracic epidural analgesia, erector spinae plane block, heart surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 25 Oct 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.
Postoperative pain negatively effects respiratory functions in open heart surgeries. The aim of the study is to compare the effects of thoracic epidural analgesia (TEA) and erector spinae plane block (ESPB) on postoperative pain and respiratory functions in patients undergoing open heart surgery with sternotomy
Detailed description
Thoracic epidural catheter was inserted to patients in Group T at the T4-T5 vertebra level before induction of general anesthesia. And then local anesthetic infusion was started until postoperative 48. hours.
Bilateral erector spinae plan block was applied with total 40 ml of local anesthetic solution to patients in Group E at the T4-T5 vertebra level before induction of general anesthesia.
The control group was infused with 1 mcg/kg/min fentanyl during the surgery. In the postoperative period, 1 g paracetamol was infused 4 times a day.
All patients underwent general anesthesia with the same method and medications.
Tramadol/diclofenac was administered to patients with a pain score (NRS) above 4. NRS and tidal volumes (TV) of the patients were measured at 0, 2, 6, 12, 24, 36 and 48. hours after extubation. Postoperative mechanical ventilation durations, intensive care unit and hospital stays, additional analgesic needs and respiratory complications of the patients were recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- The effects of thoracic epidural analgesia and erector spinae plane block on postoperative pain were compared with the control group.
| Arm | Type | Receives |
|---|---|---|
| Thoracic epidural analgesia | Active comparator | Procedure: Thoracic epidural analgesiaThoracic epidural analgesia have been started preoperatively and coninuoed until postoperative 48 hours |
| Erector spinae plane block | Active comparator | Procedure: Erector spinae plane blockErector spinae plane blockwas applied preoperatively |
| Intravenous opioid analgesia | No intervention | –Intravenous opioid analgesia was administered during the surgery |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Has ASA II-IV score
- Having open heart surgery
Key exclusion criteria (3 listed)
- Having a psychiatric illness
- Using analgesic medication due to chronic pain
- Uncooperative
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 |
|---|---|---|
| Thoracic epidural analgesiaThoracic epidural analgesia was started preoperatively and rest posoperative 48 hours | Procedure or surgery | Thoracic epidural analgesia |
| Erector spinae plane blockErector spinae plane block was applied preoperatively using local anesthetic | Procedure or surgery | Erector spinae plane block |
Primary outcome
Postoperative pain
Time frame: Postoperative 48 hours
Patients were asked about their pain levels. Rating done with VRS (Verbal Rating Scale). Pain levels were evaluated between 0 and 10 points. 0: No pain (the best)….. 10: Unbearable pain (the worst)
Respiratory functions
Time frame: Postoperative 48 hours
Oxygen requirement:If more than 4 l/min oxygen support via face mask is required to maintain peripheral oxygen saturation (SpO2) above 90%, it is defined as oxygen requirement. Tachypnea:more than 20/min Fever: more than 37 C celcius Non invasive mechanical ventilation requirement:To patients whose breathing is impaired after extubation (who have tachypnea and have SpO2 less than 90% despite receiving oxygen support of more than 4 l/min oxygen support via face mask)
2 secondary outcomes
Analgesic requirement. When the VRS was more than 4 points
Time frame: Postoperative 48 hours
Intensive care and hospital stay
Time frame: postoperative 30 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 25 Oct 2023.
- Individual participant dataSharing planned: Yes. all collected IPD
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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.
Engin Ertürk, Prof. Dr principal investigator
Karadeniz Technical University, Medical Faculty, Anesthesiology and Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic epidural analgesia and Erector spinae plane block in people with Pain, Postoperative and Respiratory Complication, run by Karadeniz Technical 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 2 inclusion and 3 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 25 Oct 2023. 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 pain (time frame: Postoperative 48 hours). The study lists 2 primary outcomes in all. 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 25 Oct 2023.