Ultrasound-Guided vs. Surgeon-Performed (Free-hand) Erector Spinae Plane Block

NCT07454304 | Completed

• 1 other identifier: E-10840098-772.02-3995
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the analgesic efficacy of ultrasound-guided (USG) lumbar Erector Spinae Plane Block (ESPB) performed by an anesthesiologist versus a "free-hand" ESPB performed intraoperatively by the surgeon in patients undergoing Unilateral Biportal Endoscopic Discectomy (UBE). The investigators hypothesize that Us-guided would provide more effective analgesia, and USG-guided application might provide more precise local anesthetic spread.

Conditions

Lumbar Disc Herniation; Lumbar Disc Disease

Keywords

Unilateral Biportal Endoscopic Discectomy; Postoperative analgesia management; Erector Spinae Plane Block

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Score (NRS) at 6th hour.

  Pain intensity measured by NRS (0-10, where 0=no pain, 10=worst pain).

  6 hours after surgery.

Secondary Outcomes (3)

• Postoperative Pain Score / NRS at other intervals

  Changes from baseline pain scores at postoperative 1, 2, 12, and 24 hours

• Rescue Analgesic Consumption

  Postoperative 24 hours period

• Opioid-related Side Effects

  Postoperative 24 hours period

Study Arms (2)

Group US-ESPB

ACTIVE COMPARATOR

Patients in this group received an ultrasound-guided lumbar Erector Spinae Plane Block performed by an experienced anesthesiologist.

Drug: US-guided ESPB.

Group Surgeon-ESPB

EXPERIMENTAL

Patients in this group received a free-hand (intraoperative) lumbar Erector Spinae Plane Block performed by the neurosurgeon.

Drug: Surgeon-performed (Free-hand) ESPB.

Interventions

US-guided ESPB. DRUG

At the end of the surgery, the patient in the prone position, an experienced anesthesiologist performed the ESPB using a low-frequency convex ultrasound probe. To avoid potential interference from surgical anatomical distortion at the operative level, the block was performed one vertebral level cranial to the surgical site. Under ultrasound guidance, the transverse process was identified, and 30 ml of 0.25% bupivacaine was injected into the fascial plane between the erector spinae muscle and the transverse process

Group US-ESPB

Surgeon-performed (Free-hand) ESPB. DRUG

During the UBE procedure, the surgeon performed the ESPB under direct/endoscopic vision. Similar to the USG group, the injection was performed one vertebral level above the targeted surgical level to ensure optimal fascial plane spread, unaffected by surgical tissue disruption. Before wound closure, 30 ml of 0.25% bupivacaine was injected into the space between the erector spinae muscle and the transverse process.

Group Surgeon-ESPB

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I-II.
• Scheduled for elective UBE surgery.

You may not qualify if:

• Infection at the injection site.
• Coagulopathy or bleeding disorders.
• Allergy to local anesthetics.
• Chronic opioid use.
• Cognitive dysfunction.

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

Location

Related Publications (2)

• Mirkheshti A, Raji P, Komlakh K, Salimi S, Shakeri A. The efficacy of ultrasound-guided erector spinae plane block (ESPB) versus freehand ESPB in postoperative pain management after lumbar spinal fusion surgery: a randomized, non-inferiority trial. Eur Spine J. 2024 Mar;33(3):1081-1088. doi: 10.1007/s00586-023-08101-9. Epub 2024 Jan 3.

  PMID: 38170270 BACKGROUND

• Kaciroglu A, Ekinci M, Gurbuz H, Ulusoy E, Ekici MA, Dogan O, Golboyu BE, Alver S, Ciftci B. Surgical vs ultrasound-guided lumbar erector spinae plane block for pain management following lumbar spinal fusion surgery. Eur Spine J. 2024 Jul;33(7):2630-2636. doi: 10.1007/s00586-024-08347-x. Epub 2024 Jun 4.

  PMID: 38834814 BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Displacement; Intervertebral disc disease

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor and participant were blinded to the study
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a prospective, randomized, single-blind, parallel-group clinical trial. Patients undergoing elective Unilateral Biportal Endoscopic Discectomy (UBE) were randomized in a 1:1 ratio into two groups using a computer-generated randomization schedule. The study model aims to compare the clinical equivalence or superiority of a surgeon-performed (free-hand) ESPB technique against the conventional ultrasound-guided (USG) ESPB performed by an anesthesiologist. Both groups received a standardized volume and concentration of local anesthetic (30 ml of 0.25% bupivacaine) to ensure comparability of the analgesic effect

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 6, 2026
• Study Start: August 1, 2022
• Primary Completion: December 20, 2025
• Study Completion: December 25, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)