Lumbar Spine SurgeryNCT06303557
Effect of ESPB on Intraoperative Remifentanil Consumption
A study testing Preoperative Erector Spinae Plane Block and Postoperative Erector Spinae Plane Block in people with Lumbar Spine Surgery and Erector Spinae Plane Block, run by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In recent years, regional anesthesia techniques have also been frequently applied to patients for pain relief. Erector spinae plane block (ESPB), is among the regional anesthesia techniques frequently used in lumbar spine surgery. General anesthesia (GA) is the main method of anesthesia for lumbar spine surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Spine Surgery, Erector Spinae Plane Block, Remifentanil Consumption
- What is being tested?
- Preoperative Erector Spinae Plane Block and Postoperative Erector Spinae Plane Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jan 2024to 13 Nov 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 65 years old
- American Society of Anesthesiologists (ASA) physical status I-II-III
- Body mass index 18 to 30 kg/m2
- Elective lumbar disc herniation surgery
Who cannot join
- Patient refusing the procedure
- Patients who have previously undergone spinal surgery
- Chronic opioid or analgesic use
- Patients who will operate under emergency conditions
- Patients who will not undergo lumbar disc herniation surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Yenimahalle, Ankara, 06170
About this study
Official title: Effect of ESPB on Intraoperative Remifentanil Consumption in Lumbar Spine Surgery
In recent years, regional anesthesia techniques have also been frequently applied to patients for pain relief. Erector spinae plane block (ESPB), is among the regional anesthesia techniques frequently used in lumbar spine surgery.
General anesthesia (GA) is the main method of anesthesia for lumbar spine surgery. However, GA can only inhibit the projection system of the cortical limbic system or hypothalamic cortex. GA cannot completely block the transmission of peripheral noxious stimulus to the central nervous system and cannot effectively inhibit the intraoperative stress response. With the addition of peripheral blocks such as ESPB, lower remifentanil consumption, and more stable hemodynamics are expected by providing preemptive analgesia in patients.
As a result of all these; it was aimed to compare the intraoperative remifentanil consumption of patients who underwent preoperative ESPB in patients who will undergo lumbar spine surgery resection under GA with those who underwent postoperative ESPB.
- Being tested
- Preoperative Erector Spinae Plane Block, Postoperative Erector Spinae Plane Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Erector Spinae Plane BlockDrug
Erector spinae plane block will be performed bilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, and when the patient is placed in the prone position.
Postoperative Erector Spinae Plane BlockDrug
Erector spinae plane block will be performed unilaterally, under US guidance, after the surgical operation, under general anesthesia, and when the patient is placed in the prone position.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative Erector Spinae Plane Block | Active comparator | In the preoperative period, under general anesthesia, after the linear ultrasound (US) probe will be placed 2-3 cm lateral to the L3 spinous process, 15 ml of 0.25% bupivacaine will be injected into the interfacial space below the erector spinae muscle, above the transverse process. The same ESPB procedure was performed on the other side. In total, 30 ml of 0.25% bupivacaine was administered. Receives: Drug: Preoperative Erector Spinae Plane Block |
| Postoperative Erector Spinae Plane Block | Active comparator | In the postoperative period, under general anesthesia, after the linear ultrasound (US) probe will be placed 2-3 cm lateral to the L3 spinous process, 15 ml of 0.25% bupivacaine will be injected into the interfacial space below the erector spinae muscle, above the transverse process. The same ESPB procedure was performed on the other side. In total, 30 ml of 0.25% bupivacaine was administered. Receives: Drug: Postoperative Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative remifentanil consumption
The amount of remifentanil that patients need to maintain anesthesia during the intraoperative period will be recorded.
Measured: During the intraoperative period
Secondary outcomes (3)
Mean arterial pressure
Mean arterial pressure values will be recorded before anesthesia, before surgical incision, after surgical incision at the 5th, 30th, 60th, 90th, 120th minutes, and after general anesthesia.
Measured: Perioperative period
Heart rate
Heart rate values will be recorded before anesthesia, before surgical incision, after surgical incision at the 5th, 30th, 60th, 90th, 120th minutes, and after general anesthesia.
Measured: Perioperative period
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 the 1st, 2nd, 6th, 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 posted12 Mar 2024
- Study start31 Jan 2024
- Primary completion3 Nov 2025
- Study completion13 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spine SurgeryStudies 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, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303557
- Sponsor's protocol ID
- AEŞH-EK1-2023-797
- Status last verified
- Nov 2025
- First submitted
- 26 Feb 2024
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of ESPB on Intraoperative Remifentanil Consumption in Lumbar Spine Surgery
- ClinicalTrials.gov ID
- NCT06303557
- Acronym / sponsor ID
- AEŞH-EK1-2023-797
- 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
- 31 Jan 2024 (actual)
- Primary completion
- 3 Nov 2025 (actual)
- Study completion
- 13 Nov 2025 (actual)
- First posted
- 12 Mar 2024 (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.
In recent years, regional anesthesia techniques have also been frequently applied to patients for pain relief. Erector spinae plane block (ESPB), is among the regional anesthesia techniques frequently used in lumbar spine surgery.
General anesthesia (GA) is the main method of anesthesia for lumbar spine surgery. However, GA can only inhibit the projection system of the cortical limbic system or hypothalamic cortex. GA cannot completely block the transmission of peripheral noxious stimulus to the central nervous system and cannot effectively inhibit the intraoperative stress response. With the addition of peripheral blocks such as ESPB, lower remifentanil consumption, and more stable hemodynamics are expected by providing preemptive analgesia in patients.
As a result of all these; it was aimed to compare the intraoperative remifentanil consumption of patients who underwent preoperative ESPB in patients who will undergo lumbar spine surgery resection under GA with those who underwent postoperative ESPB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative Erector Spinae Plane Block | Active comparator | Drug: Preoperative Erector Spinae Plane BlockIn the preoperative period, under general anesthesia, after the linear ultrasound (US) probe will be placed 2-3 cm lateral to the L3 spinous process, 15 ml of 0.25% bupivacaine will be injected into the interfacial space below the erector spinae muscle, above the transverse process. The same ESPB procedure was performed on the other side. In total, 30 ml of 0.25% bupivacaine was administered. |
| Postoperative Erector Spinae Plane Block | Active comparator | Drug: Postoperative Erector Spinae Plane BlockIn the postoperative period, under general anesthesia, after the linear ultrasound (US) probe will be placed 2-3 cm lateral to the L3 spinous process, 15 ml of 0.25% bupivacaine will be injected into the interfacial space below the erector spinae muscle, above the transverse process. The same ESPB procedure was performed on the other side. In total, 30 ml of 0.25% bupivacaine was administered. |
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
- American Society of Anesthesiologists (ASA) physical status I-II-III
- Body mass index 18 to 30 kg/m2
- Elective lumbar disc herniation surgery
Key exclusion criteria (5 listed)
- Patient refusing the procedure
- Patients who have previously undergone spinal surgery
- Chronic opioid or analgesic use
- Patients who will operate under emergency conditions
- Patients who will not undergo lumbar disc herniation 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 |
|---|---|---|
| Preoperative Erector Spinae Plane BlockErector spinae plane block will be performed bilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, and when the patient is placed in the prone position. | Drug | Preoperative Erector Spinae Plane Block |
| Postoperative Erector Spinae Plane BlockErector spinae plane block will be performed unilaterally, under US guidance, after the surgical operation, under general anesthesia, and when the patient is placed in the prone position. | Drug | Postoperative Erector Spinae Plane Block |
Primary outcome
Intraoperative remifentanil consumption
Time frame: During the intraoperative period
The amount of remifentanil that patients need to maintain anesthesia during the intraoperative period will be recorded.
3 secondary outcomes
Mean arterial pressure
Time frame: Perioperative period
Heart rate
Time frame: Perioperative period
Pain scores
Time frame: First 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 26 Nov 2025.
Related trials for Lumbar Spine Surgery
Not yet recruiting
Adding Different Doses of Dexmedetomidine to Bupivecaine in Erector Spinae Plane Block
Postoperative Pain in Lumbar Spine Surgery
Recruiting
Lumbar Paravertebral Block vs Erector Spinae Plane Block in Elderly Patients Undergoing Lumbar Spine Surgery
Spine Disease
Recruiting
FIBERGRAFT Aeridyan Posterolateral Fusion Study
Degenerative Spine Disease
Active, not recruiting
StUdy oN Burst Fractures (SunBurst)
Thoracolumbar Burst Fracture
Recruiting
Modified Thoracolumbar Interfascial Plane Block vs Retrolaminar Block for Pain in Lumbar Spine Surgeries
Postoperative Pain After Spinal Surgery
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 Preoperative Erector Spinae Plane Block and Postoperative Erector Spinae Plane Block in people with Lumbar Spine Surgery and Erector Spinae Plane Block, 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 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 26 Nov 2025. 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 remifentanil 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 26 Nov 2025.