Erector Spinae Plane BlockNCT05083845
The Effect of Different Local Anesthetic Volumes on Postoperative Analgesia for Thoracotomy Patients With Erector Spinae Plane Block
A study testing Same blocks with different local anesthetic volume in people with Erector Spinae Plane Block and Local Anesthetic, run by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
It is widely accepted that thoracotomy causes severe acute pain. This increases the frequency of postoperative pulmonary complications and postoperative morbidity. Many analgesic methods have been proposed for thoracotomy pain, including thoracic epidural analgesia (TEA), thoracic paravertebral block (TPVB)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Erector Spinae Plane Block, Local Anesthetic, Thoracotomy
- What is being tested?
- Same blocks with different local anesthetic volume
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2021to 9 Jul 2022
- 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
- 18 to 65 years old
- ASA physical status I-II-III
- BMI 18 to 30 kg/m2
- Elective thoracotomy surgery
Who cannot join
- Patient refusing the procedure
- Emergency surgery
- History of chronic opioid or analgesic used
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital
Keçiören, Ankara, 06000
About this study
Official title: The Effect of Different Local Anesthetic Volumes for Thoracotomy Patients With Erector Spinae Plane Block
It is widely accepted that thoracotomy causes severe acute pain. This increases the frequency of postoperative pulmonary complications and postoperative morbidity. Many analgesic methods have been proposed for thoracotomy pain, including thoracic epidural analgesia (TEA), thoracic paravertebral block (TPVB), intercostal nerve blocks (ICSB), erector spinae plane block (ESPB), serratus anterior plane block (SAPB). Among these methods, ultrasound-guided TPVB and ESPB are the most used methods. TPVB has left its place to newer techniques such as ESPB due to its proximity to the pleura and its deeper location. ESPB is more superficial, easy to access, and less likely to have complications. In addition, ESPB application is increasing in patients who underwent thoracotomy and VATS. There is no consensus on the dose of analgesia in these studies. There are studies on volumes between 10 ml and 40 ml in the literature. In this study, it was aimed to compare the volumes of 20 ml and 30 ml containing local anesthetic at the same concentration (0.25% bupivacaine) of ESPB block to be performed with USG in patients who underwent thoracotomy.
- Being tested
- Same blocks with different local anesthetic volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Same blocks with different local anesthetic volumeProcedure or surgery
Erector spinae plane block with different local anesthetic volumes will be applied to the patients under real-time ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block with 20 ml %0.25 Bupivacaine | Active comparator | Following the visualization of the anatomical structures, the nerve block needle was advanced via the in-plane technique beneath the erector spinae muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 20 ml 0.25% bupivacaine was injected into the area. Receives: Procedure: Same blocks with different local anesthetic volume |
| Erector Spinae Plane Block with 30 ml %0.25 Bupivacaine | Active comparator | Following the visualization of the anatomical structures, the nerve block needle was advanced via the in-plane technique beneath the erector spinae muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 30 ml 0.25% bupivacaine was injected into the area. Receives: Procedure: Same blocks with different local anesthetic volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores
Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at 1st, 2nd, 4th, 8th, 16th, 24th and 48th hours after surgery.
Measured: 48 hours after surgery
Secondary outcomes (1)
Morphine Consumption
Morphine consumption for 24 hours will be recorded
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start25 Aug 2021
- Primary completion9 Jun 2022
- Study completion9 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erector Spinae Plane BlockStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Musa Zengin, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083845
- Sponsor's protocol ID
- E.Kurul-E1-21-1964
- Status last verified
- Jul 2022
- First submitted
- 4 Oct 2021
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zengin M, Sazak H, Baldemir R, Ulger G, Arican D, Kaybal O, Alagoz A. Comparison of analgesic efficacy of different local anesthetic volumes for erector spinae plane block in thoracotomy patients; a prospective randomized trial. BMC Anesthesiol. 2023 Feb 6;23(1):42. doi: 10.1186/s12871-023-02004-4.
PubMed 36747119
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Local Anesthetic Volumes for Thoracotomy Patients With Erector Spinae Plane Block
- ClinicalTrials.gov ID
- NCT05083845
- Acronym / sponsor ID
- E.Kurul-E1-21-1964
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Atatürk Chest Diseases and Chest Surgery Training and Research HospitalUniversity, hospital or other
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 9 Jun 2022 (actual)
- Study completion
- 9 Jul 2022 (actual)
- First posted
- 19 Oct 2021 (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.
It is widely accepted that thoracotomy causes severe acute pain. This increases the frequency of postoperative pulmonary complications and postoperative morbidity. Many analgesic methods have been proposed for thoracotomy pain, including thoracic epidural analgesia (TEA), thoracic paravertebral block (TPVB), intercostal nerve blocks (ICSB), erector spinae plane block (ESPB), serratus anterior plane block (SAPB). Among these methods, ultrasound-guided TPVB and ESPB are the most used methods. TPVB has left its place to newer techniques such as ESPB due to its proximity to the pleura and its deeper location. ESPB is more superficial, easy to access, and less likely to have complications. In addition, ESPB application is increasing in patients who underwent thoracotomy and VATS. There is no consensus on the dose of analgesia in these studies. There are studies on volumes between 10 ml and 40 ml in the literature. In this study, it was aimed to compare the volumes of 20 ml and 30 ml containing local anesthetic at the same concentration (0.25% bupivacaine) of ESPB block to be performed with USG in patients who underwent thoracotomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block with 20 ml %0.25 Bupivacaine | Active comparator | Procedure: Same blocks with different local anesthetic volumeFollowing the visualization of the anatomical structures, the nerve block needle was advanced via the in-plane technique beneath the erector spinae muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 20 ml 0.25% bupivacaine was injected into the area. |
| Erector Spinae Plane Block with 30 ml %0.25 Bupivacaine | Active comparator | Procedure: Same blocks with different local anesthetic volumeFollowing the visualization of the anatomical structures, the nerve block needle was advanced via the in-plane technique beneath the erector spinae muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 30 ml 0.25% bupivacaine was injected into the area. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 to 65 years old
- ASA physical status I-II-III
- BMI 18 to 30 kg/m2
- Elective thoracotomy surgery
Key exclusion criteria (3 listed)
- Patient refusing the procedure
- Emergency surgery
- History of chronic opioid or analgesic used
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 |
|---|---|---|
| Same blocks with different local anesthetic volumeErector spinae plane block with different local anesthetic volumes will be applied to the patients under real-time ultrasound guidance. | Procedure or surgery | Erector Spinae Plane Block with 20 ml %0.25 Bupivacaine, Erector Spinae Plane Block with 30 ml %0.25 Bupivacaine |
Primary outcome
Pain Scores
Time frame: 48 hours after surgery
Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at 1st, 2nd, 4th, 8th, 16th, 24th and 48th hours after surgery.
1 secondary outcome
Morphine Consumption
Time frame: 24 hours after surgery
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 12 Jul 2022.
- Derived from this study: PubMed 36747119Zengin M, Sazak H, Baldemir R, Ulger G, Arican D, Kaybal O, Alagoz A. Comparison of analgesic efficacy of different local anesthetic volumes for erector spinae plane block in thoracotomy patients; a prospective randomized trial. BMC Anesthesiol. 2023 Feb 6;23(1):42. doi: 10.1186/s12871-023-02004-4.
- 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 Same blocks with different local anesthetic volume in people with Erector Spinae Plane Block and Local Anesthetic, run by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital 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 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 12 Jul 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?
Pain Scores (time frame: 48 hours after surgery). 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 NCT05083845, which also lists 1 linked publication.
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 12 Jul 2022.