Lumbar Microdiscectomy SurgeryNCT07652177
Comparison of the Analgesic Efficacy of Erector Spinae Plane Block in Lumbar Microdiscectomy Surgeries
An observational study of Lumbar Microdiscectomy Surgery and Lumbar Erector Spinae Plane Block, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Comparison of the Analgesic Efficacy of Lumbar Erector Spinae Plane Block and Sacral Erector Spinae Plane Block in Lumbar Microdiscectomy Surgeries Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Microdiscectomy Surgery, Lumbar Erector Spinae Plane Block, Sacral Erector Spinae Plane Block
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2025to 31 Dec 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ASA I, ASA II, and ASA III adult patients scheduled for single-level lumbar microdiscectomy at the L4-L5 or L5-S1 level.
Who may be able to join
- ASA I, ASA II, and ASA III patients scheduled for single-level lumbar microdiscectomy at the L4-L5 or L5-S1 level.
Who cannot join
- Pregnant patients
- Patients who do not consent to the erector spinae plane block
- Patients requiring mechanical ventilatory support
- Patients with a history of substance abuse
- Patients with a known allergy to the medications to be used
- Patients with bleeding diathesis
Show all 13Show fewer
- Patients with infection at the planned block site
- Patients undergoing surgical intervention at two or more spinal levels
- Patients with communication difficulties or intellectual disabilities
- Patients with neuropsychiatric disorders
- Patients with chronic pain
- Patients with an expected surgical duration of 180 minutes or more
- Patients with a prior history of lumbar microdiscectomy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Research and Training Hospital
Istanbul
About this study
Official title: Comparison of the Analgesic Efficacy of Lumbar Erector Spinae Plane Block and Sacral Erector Spinae Plane Block in Lumbar Microdiscectomy Surgeries
Comparison of the Analgesic Efficacy of Lumbar Erector Spinae Plane Block and Sacral Erector Spinae Plane Block in Lumbar Microdiscectomy Surgeries
Read the detailed description
Postoperative pain is commonly observed in patients undergoing lumbar microdiscectomy surgery.
To manage this pain, the lumbar erector spinae plane (ESP) block is frequently administered as part of a multimodal analgesia regimen, particularly with the aim of reducing opioid consumption in these patients.
Recent publications have demonstrated the analgesic efficacy of the sacral erector spinae plane block in lumbar microdiscectomy surgeries.
In this study, the postoperative analgesic effectiveness of the lumbar ESP block-performed two vertebral levels above the surgical site-will be compared with that of the sacral ESP block-performed two vertebral levels below the surgical site.
It is anticipated that this approach will provide effective analgesia while avoiding the use of opioids.
- Conditions
- Lumbar Microdiscectomy Surgery, Lumbar Erector Spinae Plane Block, Sacral Erector Spinae Plane Block, Postoperative Pain, Multimodal Analgesia Regimen, Postoperative Analgesic Effectiveness of the Lumbar ESP Block
- Keywords
- lumbar microdiscectomy surgery, lumbar erector spinae plane block, sacral erector spinae plane block, Postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| lumbar ESP | Not described | |
| sacral ESP | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
total tramadol consumption
Measured: first 24 hours after the surgery
Secondary outcomes (2)
patients' visual analog scale
To compare postoperative Visual Analog Scale (VAS) pain scores at 2, 4, 8, 12, and 24 hours.
Measured: first 24 hours after the surgery
To compare analgesic consumption during the postoperative time intervals of 0-2, 2-4, 4-8, 8-12, and 12-24 hours.
postoperative 0-2, 2-4, 4-8, 8-12, and 12-24 hours.
Measured: first 24 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start15 May 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Microdiscectomy SurgeryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, SERPİL ŞEHİRLİOĞLU, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07652177
- Sponsor's protocol ID
- GaziosmanpasaEAH LomberESP
- Status last verified
- May 2025
- First submitted
- 11 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Analgesic Efficacy of Lumbar Erector Spinae Plane Block and Sacral Erector Spinae Plane Block in Lumbar Microdiscectomy Surgeries
- ClinicalTrials.gov ID
- NCT07652177
- Acronym / sponsor ID
- GaziosmanpasaEAH LomberESP
- Conditions
- Lumbar Microdiscectomy Surgery, Lumbar Erector Spinae Plane Block, Sacral Erector Spinae Plane Block, Postoperative Pain, Multimodal Analgesia Regimen, Postoperative Analgesic Effectiveness of the Lumbar ESP Block
- Keywords
- lumbar microdiscectomy surgery, lumbar erector spinae plane block, sacral erector spinae plane block, Postoperative pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 15 May 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 16 Jun 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.
Comparison of the Analgesic Efficacy of Lumbar Erector Spinae Plane Block and Sacral Erector Spinae Plane Block in Lumbar Microdiscectomy Surgeries
Detailed description
Postoperative pain is commonly observed in patients undergoing lumbar microdiscectomy surgery.
To manage this pain, the lumbar erector spinae plane (ESP) block is frequently administered as part of a multimodal analgesia regimen, particularly with the aim of reducing opioid consumption in these patients.
Recent publications have demonstrated the analgesic efficacy of the sacral erector spinae plane block in lumbar microdiscectomy surgeries.
In this study, the postoperative analgesic effectiveness of the lumbar ESP block-performed two vertebral levels above the surgical site-will be compared with that of the sacral ESP block-performed two vertebral levels below the surgical site.
It is anticipated that this approach will provide effective analgesia while avoiding the use of opioids.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lumbar ESP | – | – |
| sacral ESP | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ASA I, ASA II, and ASA III adult patients scheduled for single-level lumbar microdiscectomy at the L4-L5 or L5-S1 level.
Key inclusion criteria (1 listed)
- ASA I, ASA II, and ASA III patients scheduled for single-level lumbar microdiscectomy at the L4-L5 or L5-S1 level.
Key exclusion criteria (13 listed)
- Pregnant patients
- Patients who do not consent to the erector spinae plane block
- Patients requiring mechanical ventilatory support
- Patients with a history of substance abuse
- Patients with a known allergy to the medications to be used
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
total tramadol consumption
Time frame: first 24 hours after the surgery
2 secondary outcomes
patients' visual analog scale
Time frame: first 24 hours after the surgery
To compare analgesic consumption during the postoperative time intervals of 0-2, 2-4, 4-8, 8-12, and 12-24 hours.
Time frame: first 24 hours after the surgery
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 16 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Lumbar Microdiscectomy Surgery and Lumbar Erector Spinae Plane Block, run by Gaziosmanpasa Research and Education Hospital 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 1 inclusion and 13 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 16 Jun 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?
total tramadol consumption (time frame: first 24 hours after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2026.