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

March 6, 2026 updated by: Bahadir Ciftci, Medipol University

Comparison of Ultrasound-Guided vs. Surgeon-Performed (Free-hand) Erector Spinae Plane Block for Postoperative Analgesia in Unilateral Biportal Endoscopic Discectomy: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Unilateral Biportal Endoscopic Discectomy (UBE) has emerged as a minimally invasive and effective surgical technique for lumbar disc herniation, offering advantages such as reduced tissue trauma and faster recovery. However, despite its minimally invasive nature, patients may still experience significant postoperative pain, which can delay mobilization and discharge. The Erector Spinae Plane Block (ESPB) is a versatile regional anesthesia technique that has gained popularity for providing effective analgesia in spinal surgeries by targeting the dorsal rami of spinal nerves.

Conventionally, ESPB is performed by anesthesiologists using ultrasound guidance (USG) before or after the surgical procedure. However, in the context of UBE, the surgeon also has direct or endoscopic access to the anatomical landmarks required for the block. A "free-hand" ESPB performed intraoperatively by the surgeon under direct vision could potentially save time and provide similar analgesic benefits without the need for additional ultrasound equipment or preoperative intervention by the anesthesiologist.

The aim of this randomized controlled trial is to compare the postoperative analgesic efficacy of ultrasound-guided (USG) lumbar ESPB performed by an anesthesiologist versus a free-hand ESPB performed intraoperatively by the surgeon in patients undergoing UBE surgery.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Bagcilar
      • Istanbul, Bagcilar, Turkey (Türkiye), 34070
        • Istanbul Medipol University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group US-ESPB
Patients in this group received an ultrasound-guided lumbar Erector Spinae Plane Block performed by an experienced anesthesiologist.
Drug: US-guided ESPB.
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
Experimental: Group Surgeon-ESPB
Patients in this group received a free-hand (intraoperative) lumbar Erector Spinae Plane Block performed by the neurosurgeon.
Drug: Surgeon-performed (Free-hand) ESPB.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Score (NRS) at 6th hour.
Time Frame: 6 hours after surgery.
Pain intensity measured by NRS (0-10, where 0=no pain, 10=worst pain).
6 hours after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rescue Analgesic Consumption
Time Frame: Postoperative 24 hours period
Total amount of Tramadol used within the first 24 hours (mg).
Postoperative 24 hours period
Opioid-related Side Effects
Time Frame: Postoperative 24 hours period
Presence of nausea, vomiting, or pruritus (Yes/No) within 24 hours.
Postoperative 24 hours period
Postoperative Pain Score / NRS at other intervals
Time Frame: Changes from baseline pain scores at postoperative 1, 2, 12, and 24 hours
NRS scores at 1, 2, 12, and 24 hours postoperatively. (0-10, where 0=no pain, 10=worst pain).
Changes from baseline pain scores at postoperative 1, 2, 12, and 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medipol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

December 20, 2025

Study Completion (Actual)

December 25, 2025

Study Registration Dates

First Submitted

March 2, 2026

First Submitted That Met QC Criteria

March 2, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-10840098-772.02-3995

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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