NCT07363096

Brief Summary

Lumbar stabilization surgery is commonly associated with moderate to severe postoperative pain. Effective pain control is important to improve patient comfort, early mobilization, and recovery. The erector spinae plane (ESP) block is a regional anesthesia technique that has been increasingly used for postoperative pain management in spine surgery. This study aims to compare the effectiveness of single-level versus two-level ultrasound-guided ESP block for postoperative pain control in patients undergoing lumbar stabilization surgery. Patients will be randomly assigned to receive either a single-level ESP block or a two-level ESP block in addition to standard analgesic treatment. Postoperative pain scores, opioid consumption, and the incidence of side effects will be evaluated during the postoperative period. The results of this study may help determine the most effective ESP block technique for pain management after lumbar stabilization surgery.

Trial Health

63
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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
8mo left

Started Feb 2026

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

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Study Timeline

Key milestones and dates

Study Progress29%
Feb 2026Jan 2027

First Submitted

Initial submission to the registry

January 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2027

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

January 15, 2026

Last Update Submit

January 15, 2026

Conditions

Postoperative Pain ManagementLumbar Spinal Fusion SurgeryErector Spina Plan Block

Keywords

Erector Spina Plane BlockAcute PainPostoperative Pain Management

Outcome Measures

Primary Outcomes (1)

  • Intraoperative Remifentanyl Consumption

    The amount of Remifentanyl that patients need to maintain anesthesia during the intraoperative period will be recorded

    During the intraoperative period

Secondary Outcomes (1)

  • Pain Scores

    First 24 hours after surgery

Study Arms (2)

Single Level Erector Spinae Plane Block

ACTIVE COMPARATOR

Participants in this arm will receive an ultrasound-guided erector spinae plane (ESP) block performed at a single vertebral level corresponding to the surgical site, in addition to standardized general anesthesia and postoperative multimodal analgesia.

Procedure: Single-Level Erector Spinae Plane Block

Two Level Erector Spinae Plane Block

ACTIVE COMPARATOR

Participants in this arm will receive an ultrasound-guided erector spinae plane (ESP) block performed at two adjacent vertebral levels, in addition to standardized general anesthesia and postoperative multimodal analgesia.

Procedure: Two-Level Erector Spinae Plane Block

Interventions

Two-Level Erector Spinae Plane BlockPROCEDURE

Ultrasound-guided erector spinae plane block performed at two adjacent vertebral levels for postoperative analgesia.

Two Level Erector Spinae Plane Block
Single-Level Erector Spinae Plane BlockPROCEDURE

Ultrasound-guided erector spinae plane block performed at a single vertebral level for postoperative analgesia.

Single Level Erector Spinae Plane Block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-II-III,
  • BMI:18-40,
  • Patients undergoing lumbar stabilization surgery involving 2 to 4 vertebral levels
  • Patients who personally provide written informed consent to participate in the study

You may not qualify if:

  • Patients with chronic pain conditions
  • Patients with a history of chronic opioid use
  • Patients undergoing emergency lumbar stabilization surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Hatice Ayça SARIBUDAK, MD

CONTACT

905437290893aycasaribudak@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology and Reanimation Specialist

Study Record Dates

First Submitted

January 15, 2026

First Posted

January 23, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 3, 2027

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)