An interventional study of NRS SCORE and Total tramadol consumption in Postoperative Pain, Chronic Postsurgical Pain and Spinal Surgery, sponsored by Aydin Adnan Menderes University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Aydin Adnan Menderes University · Not applicable, Interventional, and Prevention
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.
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 80 is close to the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Aydin Adnan Menderes University is the lead sponsor of 241 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
Refusal to participate at the time of enrollment Request to withdraw from the study Inability to provide Emergency surgery Bleeding diathesis Presence of to the local anesthetic agents used in the study Chronic opioid use Psychiatric disorders Infection at the injection site
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic Test: NRS SCORE · Diagnostic Test: Total tramadol consumption · Drug: Post Operative Pain Relievers · Diagnostic Test: S-LANSS · Diagnostic Test: BPI
Diagnostic Test: NRS SCORE · Diagnostic Test: Total tramadol consumption · Drug: Post Operative Pain Relievers · Diagnostic Test: S-LANSS · Diagnostic Test: BPI
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.
The total number of patient-controlled analgesia (PCA) bolus doses delivered within the first 24 hours will record
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.
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
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.
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.
Time frame: 3 months after surgery
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.
Time frame: 12.hours after surgery for NRS; 3 months after surgery for S-LANSS
Plan to share: Undecided
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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