Erector Spina Plan BlockNCT05944523
Comparison of the Effect of Preemptive and Post-operative Erector Spina Plane Block on Intraoperative Opioid Consumption and Postoperative Analgesia in Patients Who Will Undergo Elective Thoracotomy Surgery, Guided by the Nociception Level Index (NoL)
A study testing Erector Spina Plan Block in people with Erector Spina Plan Block and Preemptive Analgesia, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The patients who will participate in the study will be determined and informed according to the inclusion and exclusion criteria, and the patients who signed the informed consent form will be included in the study.52 patients who will undergo elective thoracotomy surgery will be divided into double-blinded 2 sided as… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Erector Spina Plan Block, Preemptive Analgesia, Thoracotomy
- What is being tested?
- Erector Spina Plan Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 May 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-65 years
- ASA classification <4
- No history of allergy or hypersensitivity to the drugs we use throughout the procedure
- BMI ≤ 35
- No history of neuropathy
- Surgeries other than emergency surgery
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- Volunteer for the study
- No presence of infection at the injection site
- No any pyschiatric disease that would prevent the evaluation of the pain score
Who cannot join
- Under the age of 18 or over the age of 65
- ASA classification ≥ 4
- History of allergy or hypersensitivity to the drugs we use throughout the procedure
- BMI > 35
- History of neuropathy
- Undergoing emergency surgery
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- Not be a volunteer for the study
- Presence of infection at the injection site
- Having a pyschiatric disease that would prevent the evaluation of the pain score
- Pregnancy
- Undergo surgery again during the postoperative follow-up period for any reason
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Medicine, Ankara University
Ankara, 06100
About this study
The patients who will participate in the study will be determined and informed according to the inclusion and exclusion criteria, and the patients who signed the informed consent form will be included in the study.52 patients who will undergo elective thoracotomy surgery will be divided into double-blinded 2 sided as preemptive and postoperative erector spina plane block.
Intraoperative pain status of the patients will be determined by the "Nociception Level Index" device and analgesia will be provided with fentanyl. The primary aim of the study is to compare the intraoperative opioid consumption of two groups with plan block at different times.
In the postoperative period, patient-controlled analgesia device will be given to both groups for rescue analgesia. The opioid consumption of the patients will be controlled in this way in the postoperative period and their pain status will be determined. The secondary aim of the study is to examine the effect of plan block application time on the postoperative period.
- Being tested
- Erector Spina Plan Block
- Keywords
- preemptive analgesia, erector spina plan block, nociception level (NoL) index, thoracotomy, opioid consumption
- Medical subject headings
- Erythema Multiforme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spina Plan BlockProcedure or surgery
Preemptive erector spina plan block and postoperative erector spina plan block were applied to patients undergoing thoracotomy. The effect of the time of application on intraoperative opioid consumption was compared with the Nociception Level Index pain monitor.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | The group in which preemptive erector spina plane block was applied Receives: Procedure: Erector Spina Plan Block |
| Group 2 | Active comparator | The group in which the end of the surgery was applied to the erector spina plane block Receives: Procedure: Erector Spina Plan Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The value of Nociception Level Index (NoL) in both preemptive and postoperative groups
We aim to determine the effect of preemptive or postoperative application of ESPB ın the amount of intraopioid consumption by Nociception Level Index
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start1 Jan 2022
- Primary completion1 Jan 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erector Spina Plan BlockStudies of the same condition, open and under way.
- More trials run by Ankara 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Canan Tokur, Ankara University
- Investigators
- Neslihan Alkış, Prof. Dr., Study director, Faculty of Medicine, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944523
- Sponsor's protocol ID
- CananT
- Status last verified
- Jul 2023
- First submitted
- 6 Jul 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Preemptive and Post-operative Erector Spina Plane Block on Intraoperative Opioid Consumption and Postoperative Analgesia in Patients Who Will Undergo Elective Thoracotomy Surgery, Guided by the Nociception Level Index (NoL)
- ClinicalTrials.gov ID
- NCT05944523
- Acronym / sponsor ID
- CananT
- Keywords
- preemptive analgesia, erector spina plan block, nociception level (NoL) index, thoracotomy, opioid consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 13 Jul 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 patients who will participate in the study will be determined and informed according to the inclusion and exclusion criteria, and the patients who signed the informed consent form will be included in the study.52 patients who will undergo elective thoracotomy surgery will be divided into double-blinded 2 sided as preemptive and postoperative erector spina plane block.
Intraoperative pain status of the patients will be determined by the "Nociception Level Index" device and analgesia will be provided with fentanyl. The primary aim of the study is to compare the intraoperative opioid consumption of two groups with plan block at different times.
In the postoperative period, patient-controlled analgesia device will be given to both groups for rescue analgesia. The opioid consumption of the patients will be controlled in this way in the postoperative period and their pain status will be determined. The secondary aim of the study is to examine the effect of plan block application time on the postoperative period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: Erector Spina Plan BlockThe group in which preemptive erector spina plane block was applied |
| Group 2 | Active comparator | Procedure: Erector Spina Plan BlockThe group in which the end of the surgery was applied to the erector spina plane block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 18-65 years
- ASA classification <4
- No history of allergy or hypersensitivity to the drugs we use throughout the procedure
- BMI ≤ 35
- No history of neuropathy
Key exclusion criteria (11 listed)
- Under the age of 18 or over the age of 65
- ASA classification ≥ 4
- History of allergy or hypersensitivity to the drugs we use throughout the procedure
- BMI > 35
- History of neuropathy
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 Spina Plan BlockPreemptive erector spina plan block and postoperative erector spina plan block were applied to patients undergoing thoracotomy. The effect of the time of application on intraoperative opioid consumption was compared with the Nociception Level Index pain monitor. | Procedure or surgery | Group 1, Group 2 |
Primary outcome
The value of Nociception Level Index (NoL) in both preemptive and postoperative groups
Time frame: Up to 24 hours
We aim to determine the effect of preemptive or postoperative application of ESPB ın the amount of intraopioid consumption by Nociception Level Index
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 13 Jul 2023.
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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.
Neslihan Alkış, Prof. Dr. study director
Faculty of Medicine, Ankara University
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 Spina Plan Block in people with Erector Spina Plan Block and Preemptive Analgesia, run by Ankara 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 9 inclusion and 11 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 13 Jul 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?
The value of Nociception Level Index (NoL) in both preemptive and postoperative groups (time frame: Up to 24 hours). 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 13 Jul 2023.