Acute PainNCT07348523
Comparison of the Postoperative Analgesic Efficacy of Classical and Modified Erector Spinae Plane Blocks After Lumbar Spinal Surgery
A study testing The Classical Erector Spinae Plane Block and Modified Erector Spinae Plane Blocks in people with Acute Pain and Spinal Stenosis Lumbar, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
The investigators aim to compare the postoperative analgesic efficacy of the classical erector spinae plane block and the modified erector spinae plane block in the management of postoperative analgesia after lumbar disc surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Pain, Spinal Stenosis Lumbar
- What is being tested?
- The Classical Erector Spinae Plane Block and Modified Erector Spinae Plane Blocks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Dec 2025to 30 Aug 2026
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-70 years,
- Classified as ASA physical status I-III,
- Scheduled to undergo single-level lumbar spinal surgery under general anesthesia
- Who agree to participate in the study by providing written informed consent
Who cannot join
- History of bleeding diathesis or current anticoagulant therapy
- Known allergy or hypersensitivity to local anesthetics or opioid medications
- Infection at the planned block injection site
- Previous lumbar spine surgery
- History of gabapentinoid or corticosteroid use within the last 3 weeks
- Inability to use a patient-controlled analgesia (PCA) device
- Suspected pregnancy, confirmed pregnancy, or breastfeeding Refusal to undergo the procedure or to participate in the study
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, 1 recruiting
- Recruiting
Samsun University
Samsun
HALE KEFELİ ÇELİK, ck_hale@hotmail.com
Betül ÇİFTÇİ KURT
About this study
Official title: Comparison of the Effectiveness of Classical and Modified Erector Spinae Plane Blocks in Postoperative Analgesia Management Following Lumbar Spinal Surgery: A Prospective Study
The investigators aim to compare the postoperative analgesic efficacy of the classical erector spinae plane block and the modified erector spinae plane block in the management of postoperative analgesia after lumbar disc surgery.
Read the detailed description
Lumbar spinal stenosis may lead to variable signs and symptoms such as low back pain, radiating pain to the lower extremities, and reduced walking capacity. Lumbar disc surgery itself causes significant pain due to extensive dissection and muscle retraction during the procedure. A multimodal analgesic approach is preferred for postoperative pain management after lumbar spine surgery. The addition of regional anesthesia techniques reduces opioid-related side effects and is associated with earlier mobilization, shorter hospital stay, and improved patient satisfaction.
In patients undergoing lumbar disc surgery, the classical erector spinae plane block and the modified erector spinae plane block provide effective analgesia for postoperative pain control.
- Conditions
- Acute Pain, Spinal Stenosis Lumbar
- Being tested
- The Classical Erector Spinae Plane Block, Modified Erector Spinae Plane Blocks
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Classical Erector Spinae Plane BlockOther
The erector spinae plane block will be performed under ultrasound guidance before the induction of general anesthesia.
Modified Erector Spinae Plane BlocksOther
Modified erector spinae plane blocks will be performed under ultrasound guidance before the induction of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Group K-ESP | Active comparator | The erector spinae plane block will be performed 30 minutes before lumbar spine surgery. Receives: Other: The Classical Erector Spinae Plane Block |
| Active Comparator: Group M-ESP | Active comparator | The modified erector spinae plane block will be performed 30 minutes before lumbar spine surgery. Receives: Other: Modified Erector Spinae Plane Blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
In the postoperative period, patients will be given opioids according to their pain density with a patient-controlled device, and the daily Morphine consumption in Patient Controlled Analgesia device will be collected and compared between groups.
Measured: 24 hours
Secondary outcomes (3)
Perioperative pain intensity
Changes in the Numerical Rating Scale (NRS) will be recorded at rest and during movement. The participant's baseline NRS will be recorded, followed by measurements before and after neuraxial positioning and up to 24 hours post-surgery.
The NRS is a unidimensional measure of pain intensity in adults. It is a segmented numerical version of the Visual Analog Scale (VAS) where the participant selects a whole number (0-10) that best represents the intensity of their pain. The 11-point numerical scale ranges from '0' representing one end of the pain spectrum (e.g. 'no pain') to '10' representing the other end (e.g. 'worst imaginable pain').
Measured: 24 hours
Quality of recovery 15 scale
Postoperative Quality of Recovery 15 in Turkish scale
Measured: 24 hours after surgery
Postoperative nausea and vomiting
Postoperative nausea and vomiting (PONV):
During follow-up, patients who experience nausea or vomiting will be evaluated using a verbal descriptive PONV scale (0=None, 1=Mild nausea, 2=Moderate nausea, 3=Single episode of vomiting, 4=More than one episode of vomiting).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start2 Dec 2025
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348523
- Sponsor's protocol ID
- OMUKAEK 2025/247
- Status last verified
- Dec 2025
- First submitted
- 31 Dec 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Classical and Modified Erector Spinae Plane Blocks in Postoperative Analgesia Management Following Lumbar Spinal Surgery: A Prospective Study
- ClinicalTrials.gov ID
- NCT07348523
- Acronym / sponsor ID
- OMUKAEK 2025/247
- Conditions
- Acute Pain, Spinal Stenosis Lumbar
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 16 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.
The investigators aim to compare the postoperative analgesic efficacy of the classical erector spinae plane block and the modified erector spinae plane block in the management of postoperative analgesia after lumbar disc surgery.
Detailed description
Lumbar spinal stenosis may lead to variable signs and symptoms such as low back pain, radiating pain to the lower extremities, and reduced walking capacity. Lumbar disc surgery itself causes significant pain due to extensive dissection and muscle retraction during the procedure. A multimodal analgesic approach is preferred for postoperative pain management after lumbar spine surgery. The addition of regional anesthesia techniques reduces opioid-related side effects and is associated with earlier mobilization, shorter hospital stay, and improved patient satisfaction.
In patients undergoing lumbar disc surgery, the classical erector spinae plane block and the modified erector spinae plane block provide effective analgesia for postoperative pain control.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Group K-ESP | Active comparator | Other: The Classical Erector Spinae Plane BlockThe erector spinae plane block will be performed 30 minutes before lumbar spine surgery. |
| Active Comparator: Group M-ESP | Active comparator | Other: Modified Erector Spinae Plane BlocksThe modified erector spinae plane block will be performed 30 minutes before lumbar spine surgery. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18-70 years,
- Classified as ASA physical status I-III,
- Scheduled to undergo single-level lumbar spinal surgery under general anesthesia
- Who agree to participate in the study by providing written informed consent
Key exclusion criteria (7 listed)
- History of bleeding diathesis or current anticoagulant therapy
- Known allergy or hypersensitivity to local anesthetics or opioid medications
- Infection at the planned block injection site
- Previous lumbar spine surgery
- History of gabapentinoid or corticosteroid use within the last 3 weeks
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 |
|---|---|---|
| The Classical Erector Spinae Plane BlockThe erector spinae plane block will be performed under ultrasound guidance before the induction of general anesthesia. | Other | Active Comparator: Group K-ESP |
| Modified Erector Spinae Plane BlocksModified erector spinae plane blocks will be performed under ultrasound guidance before the induction of general anesthesia. | Other | Active Comparator: Group M-ESP |
Primary outcome
Opioid consumption
Time frame: 24 hours
In the postoperative period, patients will be given opioids according to their pain density with a patient-controlled device, and the daily Morphine consumption in Patient Controlled Analgesia device will be collected and compared between groups.
3 secondary outcomes
Perioperative pain intensity
Time frame: 24 hours
Quality of recovery 15 scale
Time frame: 24 hours after surgery
Postoperative nausea and vomiting
Time frame: 24 hours
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 3 Feb 2026.
- Individual participant dataSharing planned: No. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
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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 The Classical Erector Spinae Plane Block and Modified Erector Spinae Plane Blocks in people with Acute Pain and Spinal Stenosis Lumbar, run by Samsun 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 3 Feb 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 HALE KEFELİ ÇELİK (5057242409, ck_hale@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption (time frame: 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 3 Feb 2026.