Postoperative Pain ManagementESP-LumbarNCT07363096
Single- Versus Two-Level ESP Block for Analgesia After Lumbar Stabilization Surgery
A study testing Single-Level Erector Spinae Plane Block and Two-Level Erector Spinae Plane Block in people with Postoperative Pain Management and Lumbar Spinal Fusion Surgery, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Lumbar stabilization surgery is commonly associated with moderate to severe postoperative pain. Effective pain control is important to improve patient comfort, early mobilization, and recovery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain Management, Lumbar Spinal Fusion Surgery, Erector Spina Plan Block
- What is being tested?
- Single-Level Erector Spinae Plane Block and Two-Level Erector Spinae Plane Block
- 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
- 1 Feb 2026to 3 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II-III,
- BMI:18-40,
- Patients undergoing lumbar stabilization surgery involving 2 to 4 vertebral levels
- Patients who personally provide written informed consent to participate in the study
Who cannot join
- Patients with chronic pain conditions
- Patients with a history of chronic opioid use
- Patients undergoing emergency lumbar stabilization surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Yenimahalle, 06170
Hatice Ayça SARIBUDAK, MD, 905437290893, aycasaribudak@gmail.com
About this study
Official title: Comparison Of Single- Versus Two-Level Erector Spinae Plane Block For Postoperative Analgesia In Patients Undergoing Lumbar Stabilization Surgery
Lumbar stabilization surgery is commonly associated with moderate to severe postoperative pain. Effective pain control is important to improve patient comfort, early mobilization, and recovery. The erector spinae plane (ESP) block is a regional anesthesia technique that has been increasingly used for postoperative pain management in spine surgery.
This study aims to compare the effectiveness of single-level versus two-level ultrasound-guided ESP block for postoperative pain control in patients undergoing lumbar stabilization surgery. Patients will be randomly assigned to receive either a single-level ESP block or a two-level ESP block in addition to standard analgesic treatment.
Postoperative pain scores, opioid consumption, and the incidence of side effects will be evaluated during the postoperative period. The results of this study may help determine the most effective ESP block technique for pain management after lumbar stabilization surgery.
- Being tested
- Single-Level Erector Spinae Plane Block, Two-Level Erector Spinae Plane Block
- Keywords
- Erector Spina Plane Block, Acute Pain, Postoperative Pain Management
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Level Erector Spinae Plane BlockProcedure or surgery
Ultrasound-guided erector spinae plane block performed at a single vertebral level for postoperative analgesia.
Two-Level Erector Spinae Plane BlockProcedure or surgery
Ultrasound-guided erector spinae plane block performed at two adjacent vertebral levels for postoperative analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Single Level Erector Spinae Plane Block | Active comparator | Participants in this arm will receive an ultrasound-guided erector spinae plane (ESP) block performed at a single vertebral level corresponding to the surgical site, in addition to standardized general anesthesia and postoperative multimodal analgesia. Receives: Procedure: Single-Level Erector Spinae Plane Block |
| Two Level Erector Spinae Plane Block | Active comparator | Participants in this arm will receive an ultrasound-guided erector spinae plane (ESP) block performed at two adjacent vertebral levels, in addition to standardized general anesthesia and postoperative multimodal analgesia. Receives: Procedure: Two-Level Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Remifentanyl Consumption
The amount of Remifentanyl that patients need to maintain anesthesia during the intraoperative period will be recorded
Measured: During the intraoperative period
Secondary outcomes (1)
Pain Scores
Pain will be assessed at rest and while movement using the from 0 ( no pain) to 10 (worst pain). Pain assessment will be done at the 1st, 2nd, 4th, 12th and 24th hours after surgery
Measured: First 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 posted23 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion3 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain ManagementStudies 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hatice Ayça Sarıbudak, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363096
- Sponsor's protocol ID
- AEŞH-EK1-2023-250
- Acronym
- ESP-Lumbar
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 23 Jan 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 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Single- Versus Two-Level Erector Spinae Plane Block For Postoperative Analgesia In Patients Undergoing Lumbar Stabilization Surgery
- ClinicalTrials.gov ID
- NCT07363096
- Acronym / sponsor ID
- ESP-Lumbar / AEŞH-EK1-2023-250
- Keywords
- Erector Spina Plane Block, Acute Pain, Postoperative Pain Management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 3 Jan 2027 (estimated)
- First posted
- 23 Jan 2026 (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.
Lumbar stabilization surgery is commonly associated with moderate to severe postoperative pain. Effective pain control is important to improve patient comfort, early mobilization, and recovery. The erector spinae plane (ESP) block is a regional anesthesia technique that has been increasingly used for postoperative pain management in spine surgery.
This study aims to compare the effectiveness of single-level versus two-level ultrasound-guided ESP block for postoperative pain control in patients undergoing lumbar stabilization surgery. Patients will be randomly assigned to receive either a single-level ESP block or a two-level ESP block in addition to standard analgesic treatment.
Postoperative pain scores, opioid consumption, and the incidence of side effects will be evaluated during the postoperative period. The results of this study may help determine the most effective ESP block technique for pain management after lumbar stabilization surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Level Erector Spinae Plane Block | Active comparator | Procedure: Single-Level Erector Spinae Plane BlockParticipants in this arm will receive an ultrasound-guided erector spinae plane (ESP) block performed at a single vertebral level corresponding to the surgical site, in addition to standardized general anesthesia and postoperative multimodal analgesia. |
| Two Level Erector Spinae Plane Block | Active comparator | Procedure: Two-Level Erector Spinae Plane BlockParticipants in this arm will receive an ultrasound-guided erector spinae plane (ESP) block performed at two adjacent vertebral levels, in addition to standardized general anesthesia and postoperative multimodal analgesia. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA I-II-III,
- BMI:18-40,
- Patients undergoing lumbar stabilization surgery involving 2 to 4 vertebral levels
- Patients who personally provide written informed consent to participate in the study
Key exclusion criteria (3 listed)
- Patients with chronic pain conditions
- Patients with a history of chronic opioid use
- Patients undergoing emergency lumbar stabilization surgery
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 |
|---|---|---|
| Single-Level Erector Spinae Plane BlockUltrasound-guided erector spinae plane block performed at a single vertebral level for postoperative analgesia. | Procedure or surgery | Single Level Erector Spinae Plane Block |
| Two-Level Erector Spinae Plane BlockUltrasound-guided erector spinae plane block performed at two adjacent vertebral levels for postoperative analgesia. | Procedure or surgery | Two Level Erector Spinae Plane Block |
Primary outcome
Intraoperative Remifentanyl Consumption
Time frame: During the intraoperative period
The amount of Remifentanyl that patients need to maintain anesthesia during the intraoperative period will be recorded
1 secondary outcome
Pain Scores
Time frame: First 24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-Level Erector Spinae Plane Block and Two-Level Erector Spinae Plane Block in people with Postoperative Pain Management and Lumbar Spinal Fusion Surgery, run by Ankara Etlik City 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: opening soon, as of the sponsor's last update on 23 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hatice Ayça SARIBUDAK, MD (905437290893, aycasaribudak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Remifentanyl Consumption (time frame: During the intraoperative period). 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 23 Jan 2026.