Lumbar Disc HerniationNCT07454304
Ultrasound-Guided vs. Surgeon-Performed (Free-hand) Erector Spinae Plane Block
A study testing US-guided ESPB. and Surgeon-performed (Free-hand) ESPB. in people with Lumbar Disc Herniation and Lumbar Disc Disease, run by Medipol University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lumbar Disc Herniation, Lumbar Disc Disease
- What is being tested?
- US-guided ESPB. and Surgeon-performed (Free-hand) ESPB.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 25 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I-II.
- Scheduled for elective UBE surgery.
Who cannot join
- Infection at the injection site.
- Coagulopathy or bleeding disorders.
- Allergy to local anesthetics.
- Chronic opioid use.
- Cognitive dysfunction.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Hospital
Istanbul, Bagcilar, 34070
About this study
Official 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
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.
Read the 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
- Lumbar Disc Herniation, Lumbar Disc Disease
- Being tested
- US-guided ESPB., Surgeon-performed (Free-hand) ESPB.
- Keywords
- Unilateral Biportal Endoscopic Discectomy, Postoperative analgesia management, Erector Spinae Plane Block
- Medical subject headings
- Intervertebral Disc Displacement, Intervertebral disc disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group US-ESPB | Active comparator | Patients in this group received an ultrasound-guided lumbar Erector Spinae Plane Block performed by an experienced anesthesiologist. Receives: 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. Receives: Drug: Surgeon-performed (Free-hand) ESPB. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Score (NRS) at 6th hour.
Pain intensity measured by NRS (0-10, where 0=no pain, 10=worst pain).
Measured: 6 hours after surgery.
Secondary outcomes (3)
Postoperative Pain Score / NRS at other intervals
NRS scores at 1, 2, 12, and 24 hours postoperatively. (0-10, where 0=no pain, 10=worst pain).
Measured: Changes from baseline pain scores at postoperative 1, 2, 12, and 24 hours
Rescue Analgesic Consumption
Total amount of Tramadol used within the first 24 hours (mg).
Measured: Postoperative 24 hours period
Opioid-related Side Effects
Presence of nausea, vomiting, or pruritus (Yes/No) within 24 hours.
Measured: Postoperative 24 hours period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Aug 2022
- Primary completion20 Dec 2025
- Study completion25 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahadir Ciftci, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454304
- Sponsor's protocol ID
- E-10840098-772.02-3995
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared
Publications
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.
PubMed 38170270Kaciroglu 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.
PubMed 38834814
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07454304
- Acronym / sponsor ID
- E-10840098-772.02-3995
- Conditions
- Lumbar Disc Herniation, Lumbar Disc Disease
- Keywords
- Unilateral Biportal Endoscopic Discectomy, Postoperative analgesia management, Erector Spinae Plane Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 25 Dec 2025 (actual)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Group US-ESPB | Active comparator | Drug: US-guided ESPB.Patients in this group received an ultrasound-guided lumbar Erector Spinae Plane Block performed by an experienced anesthesiologist. |
| Group Surgeon-ESPB | Experimental | Drug: Surgeon-performed (Free-hand) ESPB.Patients in this group received a free-hand (intraoperative) lumbar Erector Spinae Plane Block performed by the neurosurgeon. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA physical status I-II.
- Scheduled for elective UBE surgery.
Key exclusion criteria (5 listed)
- Infection at the injection site.
- Coagulopathy or bleeding disorders.
- Allergy to local anesthetics.
- Chronic opioid use.
- Cognitive dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Group US-ESPB |
| 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. | Drug | Group Surgeon-ESPB |
Primary outcome
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).
3 secondary outcomes
Postoperative Pain Score / NRS at other intervals
Time frame: Changes from baseline pain scores at postoperative 1, 2, 12, and 24 hours
Rescue Analgesic Consumption
Time frame: Postoperative 24 hours period
Opioid-related Side Effects
Time frame: Postoperative 24 hours period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Background: PubMed 38170270Mirkheshti 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.
- Background: PubMed 38834814Kaciroglu 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing US-guided ESPB. and Surgeon-performed (Free-hand) ESPB. in people with Lumbar Disc Herniation and Lumbar Disc Disease, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Score (NRS) at 6th hour. (time frame: 6 hours after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07454304, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.