Postoperative PainNCT07834502
Erector Spinae Plane Block for Chronic Pain After Spinal Surgery
A study testing NRS SCORE, Total tramadol consumption and Post Operative Pain Relievers in people with Postoperative Pain and Chronic Postsurgical Pain, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate whether the erector spinae plane (ESP) block reduces acute and chronic postoperative pain in patients undergoing spinal surgery. Participants will be assigned to study groups according to the study protocol. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain, Chronic Postsurgical Pain, Spinal Surgery
- What is being tested?
- NRS SCORE, Total tramadol consumption and Post Operative Pain Relievers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2026to 1 Jan 2029
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing elective lumbar spinal surgery
- ASA I-III
- Aged 18-75 years
Who cannot join
- Refusal to participate at the time of enrollment Request to withdraw from the study Inability to provide informed consent Emergency surgery Bleeding diathesis Presence of contraindications to the local anesthetic agents used in the study Chronic opioid use Psychiatric disorders Infection at the injection site
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
AYDIN ADNAN MENDERES ÜNİVERSİTESİ TIP FAKÜLTESİ HASTANESİ, Aydın, 09100
Aydin, 09100
SİNEM SARI, PROF DR, 902564441256, sarisinem@yahoo.com
About this study
Official title: Evaluation of the Effect of the Erector Spinae Plane (ESP) Block on Chronic Postoperative Pain After Lumbar Spine Surgery
The aim of this study is to evaluate whether the erector spinae plane (ESP) block reduces acute and chronic postoperative pain in patients undergoing spinal surgery.
Participants will be assigned to study groups according to the study protocol. Postoperative pain will be evaluated using standardized pain assessment tools. Acute postoperative pain will be assessed using the Numeric Rating Scale (NRS), while chronic pain and its impact on daily life will be evaluated using the Brief Pain Inventory (BPI). Neuropathic pain symptoms will also be assessed using the Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS).
The study aims to determine whether the use of ESP block as part of perioperative pain management can improve postoperative pain outcomes following spinal surgery.
Read the detailed description
Acute postoperative pain is common following spinal surgery, and in some patients, pain may persist beyond the expected recovery period and develop into chronic postoperative pain. Inadequate perioperative pain control may contribute to the development of persistent postoperative pain. Therefore, it is important to evaluate the effects of regional anesthesia techniques used as part of multimodal analgesia not only on early postoperative pain but also on long-term pain outcomes.
The erector spinae plane (ESP) block is an ultrasound-guided regional anesthesia technique that can be used to provide perioperative analgesia in patients undergoing spinal surgery. This study will investigate the effect of ESP block on acute postoperative pain and, particularly, on the development and severity of chronic postoperative pain following spinal surgery.
Postoperative pain intensity will be assessed during the early postoperative period, and participants will subsequently be followed for long-term pain outcomes. Chronic pain severity, its impact on daily activities, and neuropathic pain characteristics will be evaluated using standardized and validated assessment tools.
Data will be compared between patients who receive ESP block and those who do not receive the block to determine the potential effect of ESP block on long-term pain outcomes following spinal surgery.
- Being tested
- NRS SCORE, Total tramadol consumption, Post Operative Pain Relievers, S-LANSS, BPI
- Keywords
- Erector Spinae Plane Block, Brief Pain Inventory, Chronic Postsurgical Pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRS SCOREDiagnostic test
An 11-point Numerical Rating Scale (NRS), where 0 indicated no pain and 10 represented the worst pain imaginable, was used to assess patients' pain levels.
Total tramadol consumptionDiagnostic test
The total number of patient-controlled analgesia (PCA) bolus doses delivered within the first 24 hours will record
Post Operative Pain RelieversDrug
Operasyon bitiminde hastalar, postoperatif derlenme odasına alındıkları andan itibaren ilk saat 30. dk.,1.,6.,12.24.saatlerde ağrı düzeyleri Numeric Rating Scale (NRS) sistemi ile belirlenerek kayıt altına alınacaktır. Hastaya serviste tramadol PCA ve sekiz saatte bir parasetamol uygulanmaktadır. Hastanın servis takiplerinde ise saatlik NRS takibine devam edilmesi planlanmıştır. Bu dönemde NRS 4 ve üzerinde olması durumunda intramuskuler 75 mg diklofenak sodyum uygulanacaktır. Analjezi tüketim miktarı, kurtarma analjeziği ihtiyaçları ve saatleri ayrıntılı olarak not edilecek, ve belirlenen saatlerdeki NRS skorları yanı sıra kurtarma analjeziği kullanımı da istatistiksel değerlendirmeye tutulacaktır. Postoperatif analjezi planı tüm hastalara aynı şekilde uygulanacaktır.
S-LANSSDiagnostic test
The Self-completed Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS), a 7-item scale with scores ranging from 0 to 24, was used to assess neuropathic pain characteristics
BPIDiagnostic test
The BPI was used to assess pain severity and pain interference in daily life. Pain severity was calculated as the mean of 4 items, while pain interference was calculated as the mean of 7 daily life domains, with scores ranging from 0 to 10. Higher scores indicated greater pain severity and interference.
| Study group | Role | What they receive |
|---|---|---|
| ESP Block Group | Active comparator | Not described Receives: Diagnostic Test: NRS SCORE; Diagnostic Test: Total tramadol consumption; Drug: Post Operative Pain Relievers; Diagnostic Test: S-LANSS; Diagnostic Test: BPI |
| Control Group | Experimental | Not described Receives: Diagnostic Test: NRS SCORE; Diagnostic Test: Total tramadol consumption; Drug: Post Operative Pain Relievers; Diagnostic Test: S-LANSS; Diagnostic Test: BPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of ESP block on the BPI score at 3 months postoperatively in patients undergoing lumbar spine surgery.
Chronic postoperative pain severity and its impact on daily functioning will be assessed at 3 months after surgery using the Brief Pain Inventory (BPI). BPI scores will be compared between the ESP block group and the control group to evaluate the effect of ESP block on chronic postoperative pain.
Measured: 3 months after surgery
Secondary outcomes (1)
Postoperative NRS Score and Neuropathic Pain Assessed by S-LANSS
Postoperative acute pain intensity will be assessed using the Numeric Rating Scale (NRS) at 30 minutes and at 1, 6, 12, and 24 hours after surgery. The NRS score obtained at 12 hours postoperatively will serve as the primary time point for the between-group comparison of acute postoperative pain. Neuropathic pain will be evaluated at 3 months after surgery using the Self-administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS). To determine the effect of the ESP block on acute postoperative pain and neuropathic pain, the resulting scores will be compared between the ESP block group and the control group.
Measured: 12.hours after surgery for NRS; 3 months after surgery for S-LANSS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
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 Postoperative 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was designed as a double blind,prospective randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SINEM SARI, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834502
- Sponsor's protocol ID
- 2026-286
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Holderread B, Syed I, Shin C, Toussaint L 4th, Lewis A, Botros D, Avramis I, Rizkalla J. Effect of Lumbar Erector Spinae Plane Blocks After Lumbar Fusion Surgery: A Randomized Control Trial. Clin Spine Surg. 2025 Dec 1;38(10):E425-E428. doi: 10.1097/BSD.0000000000001767. Epub 2025 Feb 28.
PubMed 40019151
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of the Erector Spinae Plane (ESP) Block on Chronic Postoperative Pain After Lumbar Spine Surgery
- ClinicalTrials.gov ID
- NCT07834502
- Acronym / sponsor ID
- 2026-286
- Keywords
- Erector Spinae Plane Block, Brief Pain Inventory, Chronic Postsurgical Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 22 Sep 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 aim of this study is to evaluate whether the erector spinae plane (ESP) block reduces acute and chronic postoperative pain in patients undergoing spinal surgery.
Participants will be assigned to study groups according to the study protocol. Postoperative pain will be evaluated using standardized pain assessment tools. Acute postoperative pain will be assessed using the Numeric Rating Scale (NRS), while chronic pain and its impact on daily life will be evaluated using the Brief Pain Inventory (BPI). Neuropathic pain symptoms will also be assessed using the Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS).
The study aims to determine whether the use of ESP block as part of perioperative pain management can improve postoperative pain outcomes following spinal surgery.
Detailed description
Acute postoperative pain is common following spinal surgery, and in some patients, pain may persist beyond the expected recovery period and develop into chronic postoperative pain. Inadequate perioperative pain control may contribute to the development of persistent postoperative pain. Therefore, it is important to evaluate the effects of regional anesthesia techniques used as part of multimodal analgesia not only on early postoperative pain but also on long-term pain outcomes.
The erector spinae plane (ESP) block is an ultrasound-guided regional anesthesia technique that can be used to provide perioperative analgesia in patients undergoing spinal surgery. This study will investigate the effect of ESP block on acute postoperative pain and, particularly, on the development and severity of chronic postoperative pain following spinal surgery.
Postoperative pain intensity will be assessed during the early postoperative period, and participants will subsequently be followed for long-term pain outcomes. Chronic pain severity, its impact on daily activities, and neuropathic pain characteristics will be evaluated using standardized and validated assessment tools.
Data will be compared between patients who receive ESP block and those who do not receive the block to determine the potential effect of ESP block on long-term pain outcomes following spinal surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The study was designed as a double blind,prospective randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| ESP Block Group | Active comparator | Diagnostic Test: NRS SCORE, Diagnostic Test: Total tramadol consumption, Drug: Post Operative Pain Relievers, Diagnostic Test: S-LANSS, Diagnostic Test: BPI |
| Control Group | Experimental | Diagnostic Test: NRS SCORE, Diagnostic Test: Total tramadol consumption, Drug: Post Operative Pain Relievers, Diagnostic Test: S-LANSS, Diagnostic Test: BPI |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Undergoing elective lumbar spinal surgery
- ASA I-III
- Aged 18-75 years
Key exclusion criteria (1 listed)
- Refusal to participate at the time of enrollment Request to withdraw from the study Inability to provide informed consent Emergency surgery Bleeding diathesis Presence of contraindications to the local anesthetic agents used in the study Chronic opioid use Psychiatric disorders Infection at the injection site
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 |
|---|---|---|
| NRS SCOREAn 11-point Numerical Rating Scale (NRS), where 0 indicated no pain and 10 represented the worst pain imaginable, was used to assess patients' pain levels. | Diagnostic test | Control Group, ESP Block Group |
| Total tramadol consumptionThe total number of patient-controlled analgesia (PCA) bolus doses delivered within the first 24 hours will record | Diagnostic test | Control Group, ESP Block Group |
| Post Operative Pain RelieversOperasyon bitiminde hastalar, postoperatif derlenme odasına alındıkları andan itibaren ilk saat 30. dk.,1.,6.,12.24.saatlerde ağrı düzeyleri Numeric Rating Scale (NRS) sistemi ile belirlenerek kayıt altına alınacaktır. Hastaya serviste tramadol PCA ve sekiz saatte bir parasetamol uygulanmaktadır. Hastanın servis takiplerinde ise saatlik NRS takibine devam edilmesi planlanmıştır. Bu dönemde NRS 4 ve üzerinde olması durumunda intramuskuler 75 mg diklofenak sodyum uygulanacaktır. Analjezi tüketim miktarı, kurtarma analjeziği ihtiyaçları ve saatleri ayrıntılı olarak not edilecek, ve belirlenen saatlerdeki NRS skorları yanı sıra kurtarma analjeziği kullanımı da istatistiksel değerlendirmeye tutulacaktır. Postoperatif analjezi planı tüm hastalara aynı şekilde uygulanacaktır. | Drug | Control Group, ESP Block Group |
| S-LANSSThe Self-completed Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS), a 7-item scale with scores ranging from 0 to 24, was used to assess neuropathic pain characteristics | Diagnostic test | Control Group, ESP Block Group |
| BPIThe BPI was used to assess pain severity and pain interference in daily life. Pain severity was calculated as the mean of 4 items, while pain interference was calculated as the mean of 7 daily life domains, with scores ranging from 0 to 10. Higher scores indicated greater pain severity and interference. | Diagnostic test | Control Group, ESP Block Group |
Primary outcome
To evaluate the effect of ESP block on the BPI score at 3 months postoperatively in patients undergoing lumbar spine surgery.
Time frame: 3 months after surgery
Chronic postoperative pain severity and its impact on daily functioning will be assessed at 3 months after surgery using the Brief Pain Inventory (BPI). BPI scores will be compared between the ESP block group and the control group to evaluate the effect of ESP block on chronic postoperative pain.
1 secondary outcome
Postoperative NRS Score and Neuropathic Pain Assessed by S-LANSS
Time frame: 12.hours after surgery for NRS; 3 months after surgery for S-LANSS
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 22 Sep 2026.
- Results publication: PubMed 40019151Holderread B, Syed I, Shin C, Toussaint L 4th, Lewis A, Botros D, Avramis I, Rizkalla J. Effect of Lumbar Erector Spinae Plane Blocks After Lumbar Fusion Surgery: A Randomized Control Trial. Clin Spine Surg. 2025 Dec 1;38(10):E425-E428. doi: 10.1097/BSD.0000000000001767. Epub 2025 Feb 28.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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 NRS SCORE, Total tramadol consumption and Post Operative Pain Relievers in people with Postoperative Pain and Chronic Postsurgical Pain, run by Aydin Adnan Menderes 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 3 inclusion and 1 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 22 Sep 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 SİNEM SARI, PROF DR (902564441256, sarisinem@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effect of ESP block on the BPI score at 3 months postoperatively in patients undergoing lumbar spine surgery. (time frame: 3 months 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 NCT07834502, 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 22 Sep 2026.