NCT06303557

Brief Summary

In recent years, regional anesthesia techniques have also been frequently applied to patients for pain relief. Erector spinae plane block (ESPB), is among the regional anesthesia techniques frequently used in lumbar spine surgery. General anesthesia (GA) is the main method of anesthesia for lumbar spine surgery. However, GA can only inhibit the projection system of the cortical limbic system or hypothalamic cortex. GA cannot completely block the transmission of peripheral noxious stimulus to the central nervous system and cannot effectively inhibit the intraoperative stress response. With the addition of peripheral blocks such as ESPB, lower remifentanil consumption, and more stable hemodynamics are expected by providing preemptive analgesia in patients. As a result of all these; it was aimed to compare the intraoperative remifentanil consumption of patients who underwent preoperative ESPB in patients who will undergo lumbar spine surgery resection under GA with those who underwent postoperative ESPB.

Trial Health

87
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
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 31, 2024

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2025

Completed
Last Updated

November 26, 2025

Status Verified

November 1, 2025

Enrollment Period

1.8 years

First QC Date

February 26, 2024

Last Update Submit

November 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Intraoperative remifentanil consumption

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

    During the intraoperative period

Secondary Outcomes (3)

  • Mean arterial pressure

    Perioperative period

  • Heart rate

    Perioperative period

  • Pain scores

    First 24 hours after surgery

Study Arms (2)

Preoperative Erector Spinae Plane Block

ACTIVE COMPARATOR

In the preoperative period, under general anesthesia, after the linear ultrasound (US) probe will be placed 2-3 cm lateral to the L3 spinous process, 15 ml of 0.25% bupivacaine will be injected into the interfacial space below the erector spinae muscle, above the transverse process. The same ESPB procedure was performed on the other side. In total, 30 ml of 0.25% bupivacaine was administered.

Drug: Preoperative Erector Spinae Plane Block

Postoperative Erector Spinae Plane Block

ACTIVE COMPARATOR

In the postoperative period, under general anesthesia, after the linear ultrasound (US) probe will be placed 2-3 cm lateral to the L3 spinous process, 15 ml of 0.25% bupivacaine will be injected into the interfacial space below the erector spinae muscle, above the transverse process. The same ESPB procedure was performed on the other side. In total, 30 ml of 0.25% bupivacaine was administered.

Drug: Postoperative Erector Spinae Plane Block

Interventions

Erector spinae plane block will be performed bilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, and when the patient is placed in the prone position.

Preoperative Erector Spinae Plane Block

Erector spinae plane block will be performed unilaterally, under US guidance, after the surgical operation, under general anesthesia, and when the patient is placed in the prone position.

Postoperative Erector Spinae Plane Block

Eligibility Criteria

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

You may qualify if:

  • to 65 years old
  • American Society of Anesthesiologists (ASA) physical status I-II-III
  • Body mass index 18 to 30 kg/m2
  • Elective lumbar disc herniation surgery

You may not qualify if:

  • Patient refusing the procedure
  • Patients who have previously undergone spinal surgery
  • Chronic opioid or analgesic use
  • Patients who will operate under emergency conditions
  • Patients who will not undergo lumbar disc herniation surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Yenimahalle, Ankara, 06170, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal İnvestigator

Study Record Dates

First Submitted

February 26, 2024

First Posted

March 12, 2024

Study Start

January 31, 2024

Primary Completion

November 3, 2025

Study Completion

November 13, 2025

Last Updated

November 26, 2025

Record last verified: 2025-11

Locations