NCT07834502

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
27mo left

Started Oct 2026

Longer than P75 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

September 22, 2026

Status Verified

September 1, 2026

Enrollment Period

2 years

First QC Date

September 16, 2026

Last Update Submit

September 16, 2026

Conditions

Keywords

Erector Spinae Plane BlockBrief Pain InventoryChronic Postsurgical Pain

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months after surgery

Secondary Outcomes (1)

  • Postoperative NRS Score and Neuropathic Pain Assessed by S-LANSS

    12.hours after surgery for NRS; 3 months after surgery for S-LANSS

Study Arms (2)

ESP Block Group

ACTIVE COMPARATOR
Diagnostic Test: NRS SCOREDiagnostic Test: Total tramadol consumptionDrug: Post Operative Pain RelieversDiagnostic Test: S-LANSSDiagnostic Test: BPI

Control Group

EXPERIMENTAL
Diagnostic Test: NRS SCOREDiagnostic Test: Total tramadol consumptionDrug: Post Operative Pain RelieversDiagnostic Test: S-LANSSDiagnostic Test: BPI

Interventions

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.

Control GroupESP Block Group

The total number of patient-controlled analgesia (PCA) bolus doses delivered within the first 24 hours will record

Control GroupESP Block Group

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.

Control GroupESP Block Group
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

Control GroupESP Block Group
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.

Control GroupESP Block Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing elective lumbar spinal surgery
  • ASA I-III
  • Aged 18-75 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AYDIN ADNAN MENDERES ÜNİVERSİTESİ TIP FAKÜLTESİ HASTANESİ, Aydın, 09100

Aydin, 09100, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

SİNEM SARI, PROF DR

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The study was designed as a double blind,prospective randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PROF DR

Study Record Dates

First Submitted

September 16, 2026

First Posted

September 22, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

September 22, 2026

Record last verified: 2026-09

Locations