Erector Spinae Plane Block for Chronic Pain After Spinal Surgery

ConditionsPostoperative Pain Chronic Postsurgical Pain Spinal Surgery

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorAydin Adnan Menderes University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Undergoing elective lumbar spinal surgery

ASA I-III

Aged 18-75 years

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

NRS SCORE
Diagnostic 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 consumption
Diagnostic test
The total number of patient-controlled analgesia (PCA) bolus doses delivered within the first 24 hours will record
Post Operative Pain Relievers
Drug
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-LANSS
Diagnostic 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
BPI
Diagnostic 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.

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: ESP Block GroupActive comparator 5 interventions

Group B: Control GroupExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aydin Adnan Menderes University

Lead sponsor

Source ClinicalTrials.gov

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