NCT07403734

Brief Summary

This prospective observational study aims to evaluate the efficacy of bilateral lumbar erector spinae plane (ESP) block in providing effective postoperative analgesia and its potential impact on early mobilization and length of hospital stay in patients undergoing surgical repair of lumbar disc herniation. Regional anesthesia techniques, particularly erector spinae plane blocks, have become an integral component of multimodal analgesia strategies in postoperative pain management. The ESP block has demonstrated effective analgesia across a wide spectrum of thoracic and abdominal surgeries and is increasingly utilized due to its ease of application and safety profile. By implementing multimodal analgesic techniques, this study seeks to achieve effective pain control, reduce opioid consumption and associated complications, facilitate early mobilization, decrease hospital length of stay, and enhance patient comfort.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
active not 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

Study Start

First participant enrolled

July 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

February 4, 2026

Last Update Submit

February 4, 2026

Conditions

Keywords

lumbar erector spinae plane blockpostoperative painespblumbar disc hernia repair surgery

Outcome Measures

Primary Outcomes (1)

  • Change in Postoperative Pain Scores Using Numeric Rating Scale (NRS)

    Pain intensity will be measured using the 11-point Numeric Rating Scale (NRS: 0-10), where 0 represents "no pain" and 10 represents "worst pain imaginable." Pain scores will be assessed in three conditions: at rest, during deep breathing, and during coughing. The primary analysis will focus on pain scores at rest during the first 24 hours postoperatively.

    Assessed at 0, 15, 30, 60 minutes in the recovery unit and at 2, 6, 12, and 24 hours postoperatively on the ward (total assessment period: 24 hours)

Secondary Outcomes (9)

  • Total Opioid (Tramadol) Consumption

    24 hours postoperatively

  • Time to First Analgesic Request

    From recovery unit arrival (0 minutes) up to 24 hours postoperatively

  • Number of Analgesic Demands

    24 hours postoperatively

  • Need for Rescue Analgesia

    24 hours postoperatively

  • Incidence and Severity of Postoperative Nausea and Vomiting (PONV)

    24 hours postoperatively

  • +4 more secondary outcomes

Study Arms (2)

ESP Block Group

Patients undergoing single-level lumbar disc herniation repair surgery who receive bilateral lumbar erector spinae plane block with 0.25% bupivacaine (20 ml per side, total 40 ml) under ultrasound guidance 30 minutes prior to anesthesia induction, in addition to standardized general anesthesia and postoperative patient-controlled analgesia.

Control Group (No Block)

Patients undergoing single-level lumbar disc herniation repair surgery who receive standardized general anesthesia and postoperative patient-controlled analgesia without erector spinae plane block.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients aged 18-70 years with single-level lumbar disc herniation scheduled for surgical repair at Başakşehir Çam and Sakura City Hospital, Department of Neurosurgery. Participants must be ASA I-III, able to provide informed consent, and capable of cooperating with postoperative assessments. Patients with previous lumbar surgery, chronic pain, contraindications to regional anesthesia, or significant comorbidities will be excluded.

You may qualify if:

  • Male and female patients
  • Age 18-70 years
  • Patients scheduled to undergo single-level lumbar disc herniation repair surgery
  • American Society of Anesthesiologists (ASA) physical status classification I, II, or III
  • Willing to participate in the study (voluntary participation)
  • Fully oriented and able to cooperate with study procedures

You may not qualify if:

  • ASA physical status classification \> III
  • Patients who refuse to participate in the study
  • Age \< 18 years or \> 70 years
  • Active infection at the site of block procedure
  • Previous lumbar disc herniation surgery
  • Chronic pain condition with continuous analgesic use
  • Coagulopathy or bleeding disorders
  • Patients unable to cooperate with postoperative pain assessments
  • Known allergy to local anesthetic agents
  • Body Mass Index (BMI) \> 35 kg/m²
  • Renal insufficiency
  • Hepatic insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Başakşehir Çam Ve Sakura Şehir Hastanesi

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • Koplewicz HS. From the Editor-in-Chief's Desk. J Child Adolesc Psychopharmacol. 2018 Jun;28(5):297. doi: 10.1089/cap.2018.29149.hsk. No abstract available.

  • Ivanusic J, Konishi Y, Barrington MJ. A Cadaveric Study Investigating the Mechanism of Action of Erector Spinae Blockade. Reg Anesth Pain Med. 2018 Aug;43(6):567-571. doi: 10.1097/AAP.0000000000000789.

  • Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

MeSH Terms

Conditions

Pain, PostoperativeIntervertebral Disc DisplacementPatient Satisfaction

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsSpinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Doctor

Study Record Dates

First Submitted

February 4, 2026

First Posted

February 11, 2026

Study Start

July 1, 2024

Primary Completion

January 1, 2025

Study Completion

March 1, 2026

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations