Clinical Trials Directory

Trials / Completed

CompletedNCT07454304

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
102 (actual)
Sponsor
Medipol University · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
DRUGUS-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
DRUGSurgeon-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.

Timeline

Start date
2022-08-01
Primary completion
2025-12-20
Completion
2025-12-25
First posted
2026-03-06
Last updated
2026-03-10

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07454304. Inclusion in this directory is not an endorsement.