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NCT Number: NCT07454304

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

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.

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Key information

Conditions

Lumbar Disc Herniation Bone Diseases Hernia Intervertebral Disc Displacement Intervertebral disc disease Lumbar Disc Disease Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. Rescue Analgesic Consumption

    Time frame: Postoperative 24 hours period

    Total amount of Tramadol used within the first 24 hours (mg).

  3. Opioid-related Side Effects

    Time frame: Postoperative 24 hours period

    Presence of nausea, vomiting, or pruritus (Yes/No) within 24 hours.

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 6, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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