NCT07348523

Brief Summary

The investigators aim to compare the postoperative analgesic efficacy of the classical erector spinae plane block and the modified erector spinae plane block in the management of postoperative analgesia after lumbar disc surgery.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress58%
Dec 2025Aug 2026

Study Start

First participant enrolled

December 2, 2025

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

December 31, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

February 3, 2026

Status Verified

December 1, 2025

Enrollment Period

9 months

First QC Date

December 31, 2025

Last Update Submit

February 2, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Opioid consumption

    In the postoperative period, patients will be given opioids according to their pain density with a patient-controlled device, and the daily Morphine consumption in Patient Controlled Analgesia device will be collected and compared between groups.

    24 hours

Secondary Outcomes (3)

  • Perioperative pain intensity

    24 hours

  • Quality of recovery 15 scale

    24 hours after surgery

  • Postoperative nausea and vomiting

    24 hours

Study Arms (2)

Active Comparator: Group K-ESP

ACTIVE COMPARATOR

The erector spinae plane block will be performed 30 minutes before lumbar spine surgery.

Other: The Classical Erector Spinae Plane Block

Active Comparator: Group M-ESP

ACTIVE COMPARATOR

The modified erector spinae plane block will be performed 30 minutes before lumbar spine surgery.

Other: Modified Erector Spinae Plane Blocks

Interventions

The erector spinae plane block will be performed under ultrasound guidance before the induction of general anesthesia.

Active Comparator: Group K-ESP

Modified erector spinae plane blocks will be performed under ultrasound guidance before the induction of general anesthesia.

Active Comparator: Group M-ESP

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18-70 years,
  • Classified as ASA physical status I-III,
  • Scheduled to undergo single-level lumbar spinal surgery under general anesthesia
  • Who agree to participate in the study by providing written informed consent

You may not qualify if:

  • History of bleeding diathesis or current anticoagulant therapy
  • Known allergy or hypersensitivity to local anesthetics or opioid medications
  • Infection at the planned block injection site
  • Previous lumbar spine surgery
  • History of gabapentinoid or corticosteroid use within the last 3 weeks
  • Inability to use a patient-controlled analgesia (PCA) device
  • Suspected pregnancy, confirmed pregnancy, or breastfeeding Refusal to undergo the procedure or to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun University

Samsun, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

HALE KEFELİ ÇELİK

CONTACT

BETÜL ÇİFTÇİ KURT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2025

First Posted

January 16, 2026

Study Start

December 2, 2025

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

February 3, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Locations