Erector Spina Plan BlockESPBNCT07537647
The Effect of bılateral Erector spına Plan Block on postoperatıve paın ın spınal Surgery
A study testing UNDER ULTRASOUND GUİDANCE ESPB BLOCK and PROCEDURE/SURGERY: ERECTOR SPİNAE (ESP) BLOCK WİTH BUPİVACAİNE in people with Erector Spina Plan Block, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Patients undergoing lumbar spinal stabilization surgery may experience severe postoperative pain lasting at least three days. Analgesia after lumbar stabilization surgery is beneficial for early recovery and is therefore necessary. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Erector Spina Plan Block
- What is being tested?
- UNDER ULTRASOUND GUİDANCE ESPB BLOCK and PROCEDURE/SURGERY: ERECTOR SPİNAE (ESP) BLOCK WİTH BUPİVACAİNE
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 1 May 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Patients who volunteer to participate in the study
- Patients aged 18-65 years
- Patients with ASA (American Society of Anesthesiologists) physical status I, II, and III
- Patients who will undergo elective lumbar stabilization surgery
Who cannot join
- • Patients who do not consent to participate in the study
- Patients with ASA physical status IV and V
- Patients using anticoagulant medications
- Patients with allergy to local anesthetic drugs
- Patients undergoing lumbar stabilization surgery at level three or higher
- Patients with a history of gastrointestinal bleeding
Show all 9Show fewer
- Patients with a history of psychiatric illness (Major Depression, Schizophrenia, Bipolar Affective Disorder)
- Patients with narcotic drug and/or alcohol dependence
- Patients with a history of central and/or peripheral neurological disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa yüksek ihtisas eğitim ve araştırma hastanesi BURSA, Bursa, Türkiye, BURSA, Bursa 16310
Bursa, Bursa, 16310
About this study
Official title: The Effect of Bilateral Erector Spina Plan Block Performed After Lumbar Spinal Stabilization Surgery on Postoperative Patient Recovery and Pain
Patients undergoing lumbar spinal stabilization surgery may experience severe postoperative pain lasting at least three days. Analgesia after lumbar stabilization surgery is beneficial for early recovery and is therefore necessary. However, traditional opioid-based analgesic techniques are associated with many undesirable effects, including nausea, vomiting, itching, and sedation. Inadequate postoperative pain control also has numerous adverse effects on physiological systems such as the cardiovascular, pulmonary, gastrointestinal, immunological, renal, and hematological systems. Furthermore, inadequate postoperative pain control increases hospital stay, mortality and morbidity, prolongs patient ambulation time, increases patient costs, reduces patient satisfaction, and can lead to chronic postoperative pain. Nonsteroidal anti-inflammatory drugs (NSAIDs), opioid analgesics, and local anesthetics are frequently preferred options for providing postoperative analgesia. In cases where these agents are insufficient to prevent pain, regional techniques are often preferred to reduce the need for opioids. Erector spina plane block (ESPB), a component of multimodal analgesia and one of the regional techniques, was first used by Forero et al. for analgesic purposes in thoracic neuropathic pain and subsequently gained popularity. While ESPB is frequently performed at the thoracic level, its use continues to increase today.
Read the detailed description
Ultrasound-guided erector spinae plane block (ESPB) that aims for the ventral and dorsal rami of the spinal nerves was recently introduced in spine surgery to treat postoperative pain. ESPB was reported to be effective in scoliosis surgery as it reduced the need for analgesic drugs. Due to its relative technical simplicity, the main advantages postulated for the ESPB are few complications and minimal risk for spinal cord injury.
- Conditions
- Erector Spina Plan Block
- Being tested
- UNDER ULTRASOUND GUİDANCE ESPB BLOCK, PROCEDURE/SURGERY: ERECTOR SPİNAE (ESP) BLOCK WİTH BUPİVACAİNE
- Keywords
- ESPB, spine surgery, postoperative analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UNDER ULTRASOUND GUİDANCE ESPB BLOCKDevice
Also called ESPB BLOCK
In the ESP Block group, with the patient in the prone position, the research anesthesia team will insert a block needle through the skin one level above the surgical level using a linear probe guided by USG. The needle will pass through the trapezius and erector spinae muscles, and upon reaching the transverse process (approximately 2-3 cm deep), a test dose of 0.5-1 mL of 0.9% NaCl will be applied between the erector spinae fascia and the vertebral transverse process to confirm needle placement. After confirmation of fascial opening, a local anesthetic volume of 2 mL per vertebral pressure will be calculated, not exceeding a maximum dose of 2 mg/kg of 0.5% bupivacaine. This total volume will be diluted by half with 0.9% NaCl solution to prepare a 0.25% bupivacaine concentration. The calculated local anesthetic solution will be applied to the erector spinae region for ESPB. The same procedures will be performed on the opposite side.
PROCEDURE/SURGERY: ERECTOR SPİNAE (ESP) BLOCK WİTH BUPİVACAİNEProcedure or surgery
Also called PLANE BLOCKS
For the ESP Block group, under USG guidance with the patient in prone position, a linear probe will be placed in the parasagittal plane one level above the operative level, and after visualizing the transverse process with an in-plane approach, a 50 mm long block needle will be inserted through the skin. A test dose of 0.5-1 mL of 0.9% NaCl will be administered between the erector spinae fascia and the transverse process of the vertebra to confirm needle placement. After confirming that the fascia has opened, a local anesthetic volume of 2 mL per vertebral pressure will be calculated, not exceeding a maximum dose of 2 mg/kg of 0.5% bupivacaine. This total volume will be diluted halfway with 0.9% NaCl solution to prepare a 0.25% bupivacaine concentration. The calculated local anesthetic solution will be administered to the erector spinae area, and ESPB will be performed. The same procedures will be performed on the opposite side.
| Study group | Role | What they receive |
|---|---|---|
| ESPB GROUP | Experimental | Under ultrasound guidance, bilateral erector spinae plane block will be performed on the ESPB group one level above the appropriate area for pediatric tethered cord surgery using the anesthetic drug bupivacaine. Receives: Device: UNDER ULTRASOUND GUİDANCE ESPB BLOCK; Procedure: PROCEDURE/SURGERY: ERECTOR SPİNAE (ESP) BLOCK WİTH BUPİVACAİNE |
What is being measured
The primary outcome is the main question the study is designed to answer.
POSTOPERATIVE PAIN SCORES
Pain will be assessed using the Numerical rating scale (NRS) score at postoperatively.
Measured: The Numerical rating scale (NRS) score will be applied at 0, 2, 4, 6, 12, and 24 hours postoperatively.Numerical rating scale (NRS), 0 to 10. Zero indicates the absence of pain, while ten indicates severe pain.
Secondary outcomes (1)
Evaluation of postoperative analgesic consumption and hospital stay duration.
As a secondary measure, the effect of bilateral erector spinae plane blocks performed after lumbar spinal stabilization surgery on analgesic use during the 24-hour postoperative period and total hospital stay will be evaluated.
-Evaluation of analgesic consumption:
Total Fentanyl (micrograms) Total Contromal (milligrams) Total Paracetamol (milligrams) Total dexketoprofen trometamol (milligrams)
-Evaluation of total hospital stay (days).
Measured: Postoperative 24-hour period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 Sep 2024
- Primary completion1 Apr 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erector Spina Plan BlockStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, sermın emınoglu, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537647
- Sponsor's protocol ID
- BUUKAEK-2024-4/4
- Acronym
- ESPB
- Status last verified
- Oct 2026
- First submitted
- 6 Apr 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study protocol and results can be shared.
Publications
Stewart JW, Dickson D, Van Hal M, Aryeetey L, Sunna M, Schulz C, Alexander JC, Gasanova I, Joshi GP. Ultrasound-guided erector spinae plane blocks for pain management after open lumbar laminectomy. Eur Spine J. 2024 Mar;33(3):949-955. doi: 10.1007/s00586-023-07881-4. Epub 2023 Aug 12.
PubMed 37572144
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bilateral Erector Spina Plan Block Performed After Lumbar Spinal Stabilization Surgery on Postoperative Patient Recovery and Pain
- ClinicalTrials.gov ID
- NCT07537647
- Acronym / sponsor ID
- ESPB / BUUKAEK-2024-4/4
- Conditions
- Erector Spina Plan Block
- Keywords
- ESPB, spine surgery, postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 17 Apr 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.
Patients undergoing lumbar spinal stabilization surgery may experience severe postoperative pain lasting at least three days. Analgesia after lumbar stabilization surgery is beneficial for early recovery and is therefore necessary. However, traditional opioid-based analgesic techniques are associated with many undesirable effects, including nausea, vomiting, itching, and sedation. Inadequate postoperative pain control also has numerous adverse effects on physiological systems such as the cardiovascular, pulmonary, gastrointestinal, immunological, renal, and hematological systems. Furthermore, inadequate postoperative pain control increases hospital stay, mortality and morbidity, prolongs patient ambulation time, increases patient costs, reduces patient satisfaction, and can lead to chronic postoperative pain. Nonsteroidal anti-inflammatory drugs (NSAIDs), opioid analgesics, and local anesthetics are frequently preferred options for providing postoperative analgesia. In cases where these agents are insufficient to prevent pain, regional techniques are often preferred to reduce the need for opioids. Erector spina plane block (ESPB), a component of multimodal analgesia and one of the regional techniques, was first used by Forero et al. for analgesic purposes in thoracic neuropathic pain and subsequently gained popularity. While ESPB is frequently performed at the thoracic level, its use continues to increase today.
Detailed description
Ultrasound-guided erector spinae plane block (ESPB) that aims for the ventral and dorsal rami of the spinal nerves was recently introduced in spine surgery to treat postoperative pain. ESPB was reported to be effective in scoliosis surgery as it reduced the need for analgesic drugs. Due to its relative technical simplicity, the main advantages postulated for the ESPB are few complications and minimal risk for spinal cord injury.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESPB GROUP | Experimental | Device: UNDER ULTRASOUND GUİDANCE ESPB BLOCK, Procedure: PROCEDURE/SURGERY: ERECTOR SPİNAE (ESP) BLOCK WİTH BUPİVACAİNEUnder ultrasound guidance, bilateral erector spinae plane block will be performed on the ESPB group one level above the appropriate area for pediatric tethered cord surgery using the anesthetic drug bupivacaine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Patients who volunteer to participate in the study
Key exclusion criteria (9 listed)
- • Patients who do not consent to participate in the study
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 |
|---|---|---|
| UNDER ULTRASOUND GUİDANCE ESPB BLOCKAlso: ESPB BLOCKIn the ESP Block group, with the patient in the prone position, the research anesthesia team will insert a block needle through the skin one level above the surgical level using a linear probe guided by USG. The needle will pass through the trapezius and erector spinae muscles, and upon reaching the transverse process (approximately 2-3 cm deep), a test dose of 0.5-1 mL of 0.9% NaCl will be applied between the erector spinae fascia and the vertebral transverse process to confirm needle placement. After confirmation of fascial opening, a local anesthetic volume of 2 mL per vertebral pressure will be calculated, not exceeding a maximum dose of 2 mg/kg of 0.5% bupivacaine. This total volume will be diluted by half with 0.9% NaCl solution to prepare a 0.25% bupivacaine concentration. The calculated local anesthetic solution will be applied to the erector spinae region for ESPB. The same procedures will be performed on the opposite side. | Device | ESPB GROUP |
| PROCEDURE/SURGERY: ERECTOR SPİNAE (ESP) BLOCK WİTH BUPİVACAİNEAlso: PLANE BLOCKSFor the ESP Block group, under USG guidance with the patient in prone position, a linear probe will be placed in the parasagittal plane one level above the operative level, and after visualizing the transverse process with an in-plane approach, a 50 mm long block needle will be inserted through the skin. A test dose of 0.5-1 mL of 0.9% NaCl will be administered between the erector spinae fascia and the transverse process of the vertebra to confirm needle placement. After confirming that the fascia has opened, a local anesthetic volume of 2 mL per vertebral pressure will be calculated, not exceeding a maximum dose of 2 mg/kg of 0.5% bupivacaine. This total volume will be diluted halfway with 0.9% NaCl solution to prepare a 0.25% bupivacaine concentration. The calculated local anesthetic solution will be administered to the erector spinae area, and ESPB will be performed. The same procedures will be performed on the opposite side. | Procedure or surgery | ESPB GROUP |
Primary outcome
POSTOPERATIVE PAIN SCORES
Time frame: The Numerical rating scale (NRS) score will be applied at 0, 2, 4, 6, 12, and 24 hours postoperatively.Numerical rating scale (NRS), 0 to 10. Zero indicates the absence of pain, while ten indicates severe pain.
Pain will be assessed using the Numerical rating scale (NRS) score at postoperatively.
1 secondary outcome
Evaluation of postoperative analgesic consumption and hospital stay duration.
Time frame: Postoperative 24-hour 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 2 Nov 2026.
- Results publication: PubMed 37572144Stewart JW, Dickson D, Van Hal M, Aryeetey L, Sunna M, Schulz C, Alexander JC, Gasanova I, Joshi GP. Ultrasound-guided erector spinae plane blocks for pain management after open lumbar laminectomy. Eur Spine J. 2024 Mar;33(3):949-955. doi: 10.1007/s00586-023-07881-4. Epub 2023 Aug 12.
- Individual participant dataSharing planned: No. The study protocol and results can be shared.
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COMPARISON OF ERECTOR SPINA PLAN BLOCK AND THORACIC PARAVERTEBRAL BLOCK FOR PERIOPERATIVE ANALGESIA
Paravertebral Block
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 UNDER ULTRASOUND GUİDANCE ESPB BLOCK and PROCEDURE/SURGERY: ERECTOR SPİNAE (ESP) BLOCK WİTH BUPİVACAİNE in people with Erector Spina Plan Block, run by Bursa Yuksek Ihtisas Training and Research 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 4 inclusion and 9 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 2 Nov 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 SCORES (time frame: The Numerical rating scale (NRS) score will be applied at 0, 2, 4, 6, 12, and 24 hours postoperatively.Numerical rating scale (NRS), 0 to 10. Zero indicates the absence of pain, while ten indicates severe pain.). 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 NCT07537647, which also lists 1 linked publication.
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 2 Nov 2026.