Lumbar Disc Disease, Lumbar Disc Herniation
Conditions
Keywords
Unilateral Biportal Endoscopic Discectomy, Postoperative analgesia management, Erector Spinae Plane Block
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.
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.
Interventions
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.
Sponsors
Medipol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Outcomes Assessor and participant were blinded to the study
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Score (NRS) at 6th hour. | 6 hours after surgery. | Pain intensity measured by NRS (0-10, where 0=no pain, 10=worst pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Score / NRS at other intervals | 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). |
| Rescue Analgesic Consumption | Postoperative 24 hours period | Total amount of Tramadol used within the first 24 hours (mg). |
| Opioid-related Side Effects | Postoperative 24 hours period | Presence of nausea, vomiting, or pruritus (Yes/No) within 24 hours. |
Countries
Turkey (Türkiye)
Outcome results
None listed