Postoperative PainNCT05312957
Efficacy of Erector Spinae Plane Block in Caridac Surgery
A study testing erector spinae plane block in people with Postoperative Pain, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
Introduction: Opioid-based pharmacological treatment is frequently used in the treatment of pain after coronary artery bypass graft (CABG) surgery. If adequate postoperative analgesia is not provided in such surgeries, pulmonary and cardiovascular complications may develop. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- erector spinae plane block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Oct 2020to 1 Dec 2021
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 50-75 years,
- at the risk of American Society of Anesthesiologists (ASA) III,
- patients who were planned off- pump CABG surgery
Who cannot join
- In the preoperative evaluation,
- patients with hypersensitivity to the drugs to be used or the substances in their composition
- patients moderate or severe left ventricular dysfunction, with bleeding disorders, with liver and kidney failure, with chronic obstructive pulmonary disease
- patients who do not have sufficient intellectual capacity to use the PCA device,
- patients who refused to participate in the study ----In the intraoperative period, patients who needed a cardiopulmonary bypass pump and those who needed an aortic balloon pump support -----In the postoperative period, patients for whom the extubation duration was longer than four hours and those who required re-exploration were excluded from the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Abant Izzet Baysal University Medical School,
Bolu, 14280
About this study
Official title: Evaluation of the Analgesic Effect of Erector Spinae Plane Block in Patients Undergoing Coronary Artery Bypass Graft Surgery: A Randomized Controlled Trial Study
Introduction: Opioid-based pharmacological treatment is frequently used in the treatment of pain after coronary artery bypass graft (CABG) surgery. If adequate postoperative analgesia is not provided in such surgeries, pulmonary and cardiovascular complications may develop. This study aimed to provide effective analgesia and reduce postoperative opioid consumption by applying preemptive erector spinae plane (ESP) block.
Methods: A total of 50 patients who underwent CABG surgery were included in this prospective randomized controlled study. Patients were randomly divided into two groups: the ESP group and the control group. The intervention to the ESP group was applied bilaterally at the T5 level before the surgery. The primary outcome was postoperative opioid consumption; the other outcomes included visual analog scale scores, intraoperative opioid consumption, and duration of hospital stay.
Read the detailed description
Study Design and Patient: This prospective randomized study was conducted with the approval of the local ethics committee of the Bolu Abant Izzet Baysal University in Turkey (Approval date 03/11/2020; Decision no. 2020/243). All patients who agreed to participate in the study were informed about the purpose of the study and the anesthesia method to be used, and their written consent was obtained. Sixty-five patients, aged 50-75 years, at the risk of American Society of Anesthesiologists (ASA) III, who was planned off-pump CABG surgery were invited to the study between November 2020 and April 2021. In the preoperative evaluation, patients with hypersensitivity to the drugs to be used or the substances in their composition, having moderate or severe left ventricular dysfunction, bleeding disorders, liver and kidney failure, chronic obstructive pulmonary disease, patients who do not have sufficient intellectual capacity to use the PCA device, and who refused to participate in the study were excluded from the study. In the intraoperative period, patients who needed a cardiopulmonary bypass pump and those who needed an aortic balloon pump support were excluded from the study. In the postoperative period, patients for whom the extubation duration was longer than four hours and those who required re-exploration were excluded from the study The groups were randomized; It was divided into Group E (ESP Group) and Group C (Control Group). The Ramdom.org program (https://www.random.org/lists/?mode=advanced) was used for the randomization of the groups. Demographic data (gender, age, weight, height, body mass index (BMI)) of all patients were recorded. The patients were taken to the operating room without premedication. and electrocardiography (ECG), heart rate (HR) Sist, and peripheral oxygen saturation (SpO2) values were monitored and two peripheral vascular accesses were established with an 18-gauge intravenous (IV) cannula. To provide continuous arterial blood pressure monitoring, the radial artery was cannulated by applying topical anesthesia after the Allen test.
Interventions In Group E patients, a prone position was given before general anesthesia induction. Compliance with the rules of asepsis-antisepsis was achieved. A Sonosite-180 Plus model USG (L38/10-5 MHz Transducer, SonoSite Inc., Bothell, WA 98021 USA) was used for the intervention. An adjusted linear probe was used, which was set to a depth of 2-5 cm and a frequency of 10-15 MHz. The probe was placed craniocaudally in the parasagittal plane approximately 3 cm lateral to the T5 spinous process. The T5 transverse process is detected using a planal approach. Before the procedure, the skin, subcutaneous tissue, trapezius, rhomboid, and erector spinae muscles were identified, and local anesthesia was administered using 2% lidocaine (Aritmal 2% ampoule, Osel Medicine Istanbul, Turkey). When the block needle (Stimuplex B. Braun R, Melsungen, Germany) touched the transverse process, 0.5-1 mL of the 0.9% NaCl test dose was administered between the erector spinae muscle fascia and the vertebral transverse process, and the needle location was confirmed. Then, 20 ml of 0.25% bupivacaine (Buvasin 0.5% Vem Medicine Istanbul, Turkey) was administered to this area, and an ESP block was applied (Figure 1). The same procedure was performed on the opposite side, and a bilateral ESP block was applied. The block was considered successful when cold loss developed. No preoperative procedure was applied to the Group C patients.
Anesthetic Management For the induction of general anesthesia, 2 µg/kg fentanyl (Talinat 50 mcg/ml VEM İlaç San. ve Tic. A.Ş. İstanbul, Turkey), 2 mg/kg propofol (Propofol Lipuro 1% 10mg/ml ampoule, B. Braun, Melsungen, Germany), and 0.6 mg/kg rocuronium (Esmeron 50mg/5ml Merck Sharp Dohme İlaçları Ltd. Şti. Levent/Istanbul) were given intravenously and the patient was intubated after adequate muscle relaxation was achieved. Then, central venous access was achieved. For anesthesia maintenance, 2% sevoflurane (Sevorane® Liquid 100%, AbbVie, Queenborough Kent, England) was used in 50% air and 50% oxygen. Fentanyl (0.5-2 mcg/kg) was administered 1-2 minutes before the thorax incision. An additional 1-2 mcg/kg of intravenous (IV) fentanyl was administered to patients with a 20% increase in blood pressure or heart rate. After induction, 1 mcg/kg fentanyl, and 0.25 mg/kg rocuronium were administered at half-hour intervals in both groups. Before cross-clamping the ascending aorta, the systolic pressure had aimed to be below 100 mmHg. To maintain a systolic pressure below 100 mmHg, patients were administered 1-2 mcg/kg fentanyl when necessary. Intraoperative fentanyl consumption was recorded. During anesthesia, intermittent arterial blood gas monitoring was performed on all patients. The anesthesia and surgery durations of the patients were recorded, and they were taken to the intensive care unit (ICU) as intubated after the operation. The patients were extubated within 4 hours postoperatively. Patient-controlled analgesia devices were applied to all patients after extubation. Tramadol HCl (Tramosel 100 mg/2 ml Haver Pharma İlaç A.Ş, Istanbul/Turkey) was adjusted as IV bolus 20 mg doses of tramadol HCl every time a button was pressed, at a concentration of 5mg/ml. The device was adjusted to allow a maximum dose of 400 mg in 24 hours, with a lock-in time of 20 minutes; total tramadol consumption was recorded. After extubation, VAS values were recorded at the 1st, 2nd, 4th, 8th, 12th, 18th, 24th, 36th, and 48th postoperative hours. During the 0-1, 1-12, 12-24, 24-36, and 36-48 time zones, heart rate, systolic blood pressure, mean blood pressure, diastolic blood pressure, and peripheral oxygen saturation were monitored and recorded. Nausea, vomiting, pruritus, desaturation, urinary retention, and other side effects were followed up and recorded in the patient follow-up after extubation. Postoperative nausea and vomiting were treated with 4mg of ondansetron (IV) (Ondaren 4mg/2ml Vem İlaç A.Ş Istanbul, Turkey), and rash and itching with 45.5 mg of pheniramine (IV) (Avil amp 45.5mg/2ml Sandoz İlaç A.Ş. Istanbul/Turkey). When the VAS was above four, IV 0.05 mg/kg morphine (Morphine HCL® 0.01 g/ml amp Galen İlaç A.Ş./Turkey) was administered as rescue analgesia. The extubation and ICU discharge times of the patients in both groups were recorded
- Conditions
- Postoperative Pain
- Being tested
- erector spinae plane block
- Keywords
- Erector spinae plane block,, coronary artery bypass graft surgery,, postoperative pain., opioid consumption
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erector spinae plane blockOther
Group ESP (Arm 1)The probe was placed craniocaudally in the parasagittal plane approximately 3 cm lateral to the T5 spinous process. The T5 transverse process is detected .When the block needle (Stimuplex B. Braun R, Melsungen, Germany) touched the transverse process, 0.5-1 mL of the 0.9% NaCl test dose was administered between the erector spinae muscle fascia and the vertebral transverse process, and the needle location was confirmed.Then, 20 ml of 0.25% bupivacaine was administered to this area, Group Control (Arm 2) :No intervention
| Study group | Role | What they receive |
|---|---|---|
| Group ESP | Active comparator | The probe was placed craniocaudally in the parasagittal plane approximately 3 cm lateral to the T5 spinous process. The T5 transverse process is detected and When the block needle touched the transverse process,Then, 20 ml of 0.25% bupivacaine was administered to this area, and an ESP block was applied Receives: Other: erector spinae plane block |
| Group Control | No intervention | Group Control: Tramadol HCL was administered from vein with a patient-controlled analgesia device after extubation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring opioid consumption after surgery
tramadol consumption (mg)
Measured: 0-1hours
measuring opioid consumption after surgery
tramadol consumption (mg)
Measured: 1-12hours,
measuring opioid consumption after surgery
tramadol consumption (mg)
Measured: 12-24hours,
measuring opioid consumption after surgery
tramadol consumption (mg)
Measured: 24-36hours,
measuring opioid consumption after surgery
tramadol consumption (mg)
Measured: 36-48hours
Secondary outcomes (9)
Evaluation of the postoperative visual analog scale(VAS) score
postoperative VAS score ( VAS ;subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain.")
Measured: 1st hours
Evaluation of the postoperative VAS score
postoperative VAS score(0 no pain-10 "worst pain.")
Measured: 2nd hours
Evaluation of the postoperative VAS score
postoperative VAS (0 no pain-10 "worst pain.")
Measured: 4th hours
Evaluation of the postoperative VAS score
postoperative VAS score (0 no pain-10 "worst pain.")
Measured: 8th hours
Evaluation of the postoperative VAS score
postoperative VAS score (0 no pain-10 "worst pain.")
Measured: 12th hours
Evaluation of the postoperative VAS score
postoperative VAS score (0 no pain-10 "worst pain.")
Measured: 18th hours
Evaluation of the postoperative VAS score
postoperative VAS score (0 no pain-10 "worst pain.")
Measured: 24thhours
valuation of the postoperative VAS score
postoperative VAS score (0 no pain-10 "worst pain.")
Measured: 36th hours
valuation of the postoperative VAS score
postoperative VAS score (0 no pain-10 "worst pain.")
Measured: 48th hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start14 Oct 2020
- Primary completion10 Apr 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group ESP;The probe was placed craniocaudally in the parasagittal plane approximately 3 cm lateral to the T5 spinous process T5 transverse process is detected. When the block needle (Stimuplex B. Braun R, Melsungen, Germany) touched the transverse process, 0.5-1 mL of the 0.9% NaCl test dose was administered between the erector spinae muscle fascia and the vertebral transverse process, and the needle location was confirmed. Then, 20 ml of 0.25% bupivacaine was administered to this area, and an ESP block was applied Group Control : no intervention
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312957
- Sponsor's protocol ID
- AbantIBU mb6
- Status last verified
- Mar 2022
- First submitted
- 15 Dec 2021
- Last updated
- 6 Apr 2022
- 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 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Analgesic Effect of Erector Spinae Plane Block in Patients Undergoing Coronary Artery Bypass Graft Surgery: A Randomized Controlled Trial Study
- ClinicalTrials.gov ID
- NCT05312957
- Acronym / sponsor ID
- AbantIBU mb6
- Conditions
- Postoperative Pain
- Keywords
- Erector spinae plane block,, coronary artery bypass graft surgery,, postoperative pain., opioid consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 10 Apr 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 6 Apr 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.
Introduction: Opioid-based pharmacological treatment is frequently used in the treatment of pain after coronary artery bypass graft (CABG) surgery. If adequate postoperative analgesia is not provided in such surgeries, pulmonary and cardiovascular complications may develop. This study aimed to provide effective analgesia and reduce postoperative opioid consumption by applying preemptive erector spinae plane (ESP) block.
Methods: A total of 50 patients who underwent CABG surgery were included in this prospective randomized controlled study. Patients were randomly divided into two groups: the ESP group and the control group. The intervention to the ESP group was applied bilaterally at the T5 level before the surgery. The primary outcome was postoperative opioid consumption; the other outcomes included visual analog scale scores, intraoperative opioid consumption, and duration of hospital stay.
Detailed description
Study Design and Patient: This prospective randomized study was conducted with the approval of the local ethics committee of the Bolu Abant Izzet Baysal University in Turkey (Approval date 03/11/2020; Decision no. 2020/243). All patients who agreed to participate in the study were informed about the purpose of the study and the anesthesia method to be used, and their written consent was obtained. Sixty-five patients, aged 50-75 years, at the risk of American Society of Anesthesiologists (ASA) III, who was planned off-pump CABG surgery were invited to the study between November 2020 and April 2021. In the preoperative evaluation, patients with hypersensitivity to the drugs to be used or the substances in their composition, having moderate or severe left ventricular dysfunction, bleeding disorders, liver and kidney failure, chronic obstructive pulmonary disease, patients who do not have sufficient intellectual capacity to use the PCA device, and who refused to participate in the study were excluded from the study. In the intraoperative period, patients who needed a cardiopulmonary bypass pump and those who needed an aortic balloon pump support were excluded from the study. In the postoperative period, patients for whom the extubation duration was longer than four hours and those who required re-exploration were excluded from the study The groups were randomized; It was divided into Group E (ESP Group) and Group C (Control Group). The Ramdom.org program (https://www.random.org/lists/?mode=advanced) was used for the randomization of the groups. Demographic data (gender, age, weight, height, body mass index (BMI)) of all patients were recorded. The patients were taken to the operating room without premedication. and electrocardiography (ECG), heart rate (HR) Sist, and peripheral oxygen saturation (SpO2) values were monitored and two peripheral vascular accesses were established with an 18-gauge intravenous (IV) cannula. To provide continuous arterial blood pressure monitoring, the radial artery was cannulated by applying topical anesthesia after the Allen test.
Interventions In Group E patients, a prone position was given before general anesthesia induction. Compliance with the rules of asepsis-antisepsis was achieved. A Sonosite-180 Plus model USG (L38/10-5 MHz Transducer, SonoSite Inc., Bothell, WA 98021 USA) was used for the intervention. An adjusted linear probe was used, which was set to a depth of 2-5 cm and a frequency of 10-15 MHz. The probe was placed craniocaudally in the parasagittal plane approximately 3 cm lateral to the T5 spinous process. The T5 transverse process is detected using a planal approach. Before the procedure, the skin, subcutaneous tissue, trapezius, rhomboid, and erector spinae muscles were identified, and local anesthesia was administered using 2% lidocaine (Aritmal 2% ampoule, Osel Medicine Istanbul, Turkey). When the block needle (Stimuplex B. Braun R, Melsungen, Germany) touched the transverse process, 0.5-1 mL of the 0.9% NaCl test dose was administered between the erector spinae muscle fascia and the vertebral transverse process, and the needle location was confirmed. Then, 20 ml of 0.25% bupivacaine (Buvasin 0.5% Vem Medicine Istanbul, Turkey) was administered to this area, and an ESP block was applied (Figure 1). The same procedure was performed on the opposite side, and a bilateral ESP block was applied. The block was considered successful when cold loss developed. No preoperative procedure was applied to the Group C patients.
Anesthetic Management For the induction of general anesthesia, 2 µg/kg fentanyl (Talinat 50 mcg/ml VEM İlaç San. ve Tic. A.Ş. İstanbul, Turkey), 2 mg/kg propofol (Propofol Lipuro 1% 10mg/ml ampoule, B. Braun, Melsungen, Germany), and 0.6 mg/kg rocuronium (Esmeron 50mg/5ml Merck Sharp Dohme İlaçları Ltd. Şti. Levent/Istanbul) were given intravenously and the patient was intubated after adequate muscle relaxation was achieved. Then, central venous access was achieved. For anesthesia maintenance, 2% sevoflurane (Sevorane® Liquid 100%, AbbVie, Queenborough Kent, England) was used in 50% air and 50% oxygen. Fentanyl (0.5-2 mcg/kg) was administered 1-2 minutes before the thorax incision. An additional 1-2 mcg/kg of intravenous (IV) fentanyl was administered to patients with a 20% increase in blood pressure or heart rate. After induction, 1 mcg/kg fentanyl, and 0.25 mg/kg rocuronium were administered at half-hour intervals in both groups. Before cross-clamping the ascending aorta, the systolic pressure had aimed to be below 100 mmHg. To maintain a systolic pressure below 100 mmHg, patients were administered 1-2 mcg/kg fentanyl when necessary. Intraoperative fentanyl consumption was recorded. During anesthesia, intermittent arterial blood gas monitoring was performed on all patients. The anesthesia and surgery durations of the patients were recorded, and they were taken to the intensive care unit (ICU) as intubated after the operation. The patients were extubated within 4 hours postoperatively. Patient-controlled analgesia devices were applied to all patients after extubation. Tramadol HCl (Tramosel 100 mg/2 ml Haver Pharma İlaç A.Ş, Istanbul/Turkey) was adjusted as IV bolus 20 mg doses of tramadol HCl every time a button was pressed, at a concentration of 5mg/ml. The device was adjusted to allow a maximum dose of 400 mg in 24 hours, with a lock-in time of 20 minutes; total tramadol consumption was recorded. After extubation, VAS values were recorded at the 1st, 2nd, 4th, 8th, 12th, 18th, 24th, 36th, and 48th postoperative hours. During the 0-1, 1-12, 12-24, 24-36, and 36-48 time zones, heart rate, systolic blood pressure, mean blood pressure, diastolic blood pressure, and peripheral oxygen saturation were monitored and recorded. Nausea, vomiting, pruritus, desaturation, urinary retention, and other side effects were followed up and recorded in the patient follow-up after extubation. Postoperative nausea and vomiting were treated with 4mg of ondansetron (IV) (Ondaren 4mg/2ml Vem İlaç A.Ş Istanbul, Turkey), and rash and itching with 45.5 mg of pheniramine (IV) (Avil amp 45.5mg/2ml Sandoz İlaç A.Ş. Istanbul/Turkey). When the VAS was above four, IV 0.05 mg/kg morphine (Morphine HCL® 0.01 g/ml amp Galen İlaç A.Ş./Turkey) was administered as rescue analgesia. The extubation and ICU discharge times of the patients in both groups were recorded
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group ESP;The probe was placed craniocaudally in the parasagittal plane approximately 3 cm lateral to the T5 spinous process T5 transverse process is detected. When the block needle (Stimuplex B. Braun R, Melsungen, Germany) touched the transverse process, 0.5-1 mL of the 0.9% NaCl test dose was administered between the erector spinae muscle fascia and the vertebral transverse process, and the needle location was confirmed. Then, 20 ml of 0.25% bupivacaine was administered to this area, and an ESP block was applied Group Control : no intervention
| Arm | Type | Receives |
|---|---|---|
| Group ESP | Active comparator | Other: erector spinae plane blockThe probe was placed craniocaudally in the parasagittal plane approximately 3 cm lateral to the T5 spinous process. The T5 transverse process is detected and When the block needle touched the transverse process,Then, 20 ml of 0.25% bupivacaine was administered to this area, and an ESP block was applied |
| Group Control | No intervention | –Group Control: Tramadol HCL was administered from vein with a patient-controlled analgesia device after extubation. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 50-75 years,
- at the risk of American Society of Anesthesiologists (ASA) III,
- patients who were planned off- pump CABG surgery
Key exclusion criteria (5 listed)
- In the preoperative evaluation,
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 blockGroup ESP (Arm 1)The probe was placed craniocaudally in the parasagittal plane approximately 3 cm lateral to the T5 spinous process. The T5 transverse process is detected .When the block needle (Stimuplex B. Braun R, Melsungen, Germany) touched the transverse process, 0.5-1 mL of the 0.9% NaCl test dose was administered between the erector spinae muscle fascia and the vertebral transverse process, and the needle location was confirmed.Then, 20 ml of 0.25% bupivacaine was administered to this area, Group Control (Arm 2) :No intervention | Other | Group ESP |
Primary outcome
measuring opioid consumption after surgery
Time frame: 0-1hours
tramadol consumption (mg)
measuring opioid consumption after surgery
Time frame: 1-12hours,
tramadol consumption (mg)
measuring opioid consumption after surgery
Time frame: 12-24hours,
tramadol consumption (mg)
measuring opioid consumption after surgery
Time frame: 24-36hours,
tramadol consumption (mg)
measuring opioid consumption after surgery
Time frame: 36-48hours
tramadol consumption (mg)
9 secondary outcomes
Evaluation of the postoperative visual analog scale(VAS) score
Time frame: 1st hours
Evaluation of the postoperative VAS score
Time frame: 2nd hours
Evaluation of the postoperative VAS score
Time frame: 4th hours
Evaluation of the postoperative VAS score
Time frame: 8th hours
Evaluation of the postoperative VAS score
Time frame: 12th hours
Evaluation of the postoperative VAS score
Time frame: 18th hours
Evaluation of the postoperative VAS score
Time frame: 24thhours
valuation of the postoperative VAS score
Time frame: 36th hours
valuation of the postoperative VAS score
Time frame: 48th hours
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 6 Apr 2022.
- 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.
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?
A study testing erector spinae plane block in people with Postoperative Pain, run by Abant Izzet Baysal 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 3 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 6 Apr 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?
measuring opioid consumption after surgery (time frame: 0-1hours). The study lists 5 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 6 Apr 2022.