Perioperative BleedingNCT07101198
Ultrasound-Guided Erector Spinae Plane Block in Major Spinal Surgery
A study testing Ultrasound-guided erector spinae plane block in people with Perioperative Bleeding and Opioid Consumption, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effects of ultrasound-guided bilateral erector spinae plane block on intraoperative pain control and bleeding in patients undergoing major spinal surgery. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Perioperative Bleeding, Opioid Consumption, Erector Spinae Plane Block
- What is being tested?
- Ultrasound-guided erector spinae plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jul 2025to 16 Sep 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older
- Scheduled for elective spinal stabilization surgery
- American Society of Anesthesiologists (ASA) physical status I-III
- Provided written informed consent
- Exclusion Criteria: Coagulopathy or current anticoagulant therapy
- Anatomical barrier or infection at the Erector Spinae Plane Block site
- Known allergy to local anesthetics or opioids
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effectiveness of Ultrasound-Guided Bilateral Erector Spinae Plane Block on Postoperative Pain and Bleeding in Major Spinal Surgery
This study aims to evaluate the effects of ultrasound-guided bilateral erector spinae plane block on intraoperative pain control and bleeding in patients undergoing major spinal surgery. Participants will be randomly assigned to two groups: one group will receive the Erector Spinae Plane block, while the other group will receive standard pain management. Primary outcomes include postoperative pain levels and intraoperative blood loss. This study seeks to determine whether the Erector Spinae Plane Block technique positively contributes to patient recovery and reduces bleeding complications.
Read the detailed description
This randomized controlled trial investigates the effectiveness of ultrasound-guided bilateral Erector Spinae Plane Block on intraoperative opioid consumption and bleeding in patients undergoing spinal surgery. Eligible adult patients will be enrolled after obtaining informed consent.
Participants will be randomly assigned to two groups: the intervention group will receive bilateral Erector Spinae Plane Block under ultrasound guidance before surgery, while the control group will receive standard pain management without the block. The Erector Spinae Plane Block will be performed using a standard dose of bupivacaine.
The primary outcome measure is the amount of intraoperative bleeding. Secondary outcomes include opioid consumption and incidence of complications.
This study aims to provide evidence on the efficacy of the Erector Spinae Plane Block technique in improving postoperative recovery and reducing bleeding complications in major spinal surgeries.
- Conditions
- Perioperative Bleeding, Opioid Consumption, Erector Spinae Plane Block, Spinal Stabilization
- Being tested
- Ultrasound-guided erector spinae plane block
- Keywords
- Spine Surgery, Regional Anesthesia, Blood Loss, Erector Spinae Plane Block
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided erector spinae plane blockProcedure or surgery
Patients in this group will receive an ultrasound-guided erector spinae plane block 30 minutes before surgery. A total volume of bupivacaine will be injected bilaterally into the fascial plane between the erector spinae muscle and the transverse process. All patients will also receive standard postoperative analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block Group | Experimental | Participants in this group received an ultrasound-guided Erector Spinae Plane Block preoperatively as part of multimodal analgesia. Receives: Procedure: Ultrasound-guided erector spinae plane block |
| Control Group | No intervention | Participants in this group did not receive a preoperative regional anesthesia block. Standard postoperative analgesic protocols were used. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative estimated blood loss
Intraoperative estimated blood loss (milliliters) Total amount of blood lost during surgery will be measured in milliliters. [Time Frame: During surgery]
Measured: During surgery
Secondary outcomes (1)
Total intraoperative remifentanil consumption
The total dose of remifentanil administered intraoperatively (in micrograms) will be recorded by the anesthesia team.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start26 Jul 2025
- Primary completion10 Sep 2025
- Study completion16 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative BleedingStudies 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
- Model description
- Participants will be randomly assigned to receive either ultrasound-guided Erector Spinae Plane Block or no block prior to lumbar spinal stabilization surgery.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Funda Atar, Ankara Etlik City Hospital
- Investigators
- Funda Atar, MD, Principal investigator, Ankara Etlik City HospitalDerya Özkan, prof, Study director, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101198
- Sponsor's protocol ID
- 2023-676
- Status last verified
- Jul 2026
- First submitted
- 25 Jul 2025
- Last updated
- 10 Jul 2026
- 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 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Ultrasound-Guided Bilateral Erector Spinae Plane Block on Postoperative Pain and Bleeding in Major Spinal Surgery
- ClinicalTrials.gov ID
- NCT07101198
- Acronym / sponsor ID
- 2023-676
- Conditions
- Perioperative Bleeding, Opioid Consumption, Erector Spinae Plane Block, Spinal Stabilization
- Keywords
- Spine Surgery, Regional Anesthesia, Blood Loss, Erector Spinae Plane Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 26 Jul 2025 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 16 Sep 2025 (actual)
- First posted
- 3 Aug 2025 (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.
This study aims to evaluate the effects of ultrasound-guided bilateral erector spinae plane block on intraoperative pain control and bleeding in patients undergoing major spinal surgery. Participants will be randomly assigned to two groups: one group will receive the Erector Spinae Plane block, while the other group will receive standard pain management. Primary outcomes include postoperative pain levels and intraoperative blood loss. This study seeks to determine whether the Erector Spinae Plane Block technique positively contributes to patient recovery and reduces bleeding complications.
Detailed description
This randomized controlled trial investigates the effectiveness of ultrasound-guided bilateral Erector Spinae Plane Block on intraoperative opioid consumption and bleeding in patients undergoing spinal surgery. Eligible adult patients will be enrolled after obtaining informed consent.
Participants will be randomly assigned to two groups: the intervention group will receive bilateral Erector Spinae Plane Block under ultrasound guidance before surgery, while the control group will receive standard pain management without the block. The Erector Spinae Plane Block will be performed using a standard dose of bupivacaine.
The primary outcome measure is the amount of intraoperative bleeding. Secondary outcomes include opioid consumption and incidence of complications.
This study aims to provide evidence on the efficacy of the Erector Spinae Plane Block technique in improving postoperative recovery and reducing bleeding complications in major spinal surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to receive either ultrasound-guided Erector Spinae Plane Block or no block prior to lumbar spinal stabilization surgery.
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block Group | Experimental | Procedure: Ultrasound-guided erector spinae plane blockParticipants in this group received an ultrasound-guided Erector Spinae Plane Block preoperatively as part of multimodal analgesia. |
| Control Group | No intervention | –Participants in this group did not receive a preoperative regional anesthesia block. Standard postoperative analgesic protocols were used. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients aged 18 years or older
- Scheduled for elective spinal stabilization surgery
- American Society of Anesthesiologists (ASA) physical status I-III
- Provided written informed consent
- Exclusion Criteria: Coagulopathy or current anticoagulant therapy
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Ultrasound-guided erector spinae plane blockPatients in this group will receive an ultrasound-guided erector spinae plane block 30 minutes before surgery. A total volume of bupivacaine will be injected bilaterally into the fascial plane between the erector spinae muscle and the transverse process. All patients will also receive standard postoperative analgesia. | Procedure or surgery | Erector Spinae Plane Block Group |
Primary outcome
Intraoperative estimated blood loss
Time frame: During surgery
Intraoperative estimated blood loss (milliliters) Total amount of blood lost during surgery will be measured in milliliters. [Time Frame: During surgery]
1 secondary outcome
Total intraoperative remifentanil consumption
Time frame: During 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 10 Jul 2026.
- 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.
Funda Atar, MD principal investigator
Ankara Etlik City Hospital
Derya Özkan, prof study director
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided erector spinae plane block in people with Perioperative Bleeding and Opioid Consumption, run by Diskapi Yildirim Beyazit Education 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 8 inclusion and 0 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 10 Jul 2026. 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?
Intraoperative estimated blood loss (time frame: During surgery). 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 10 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.