Erector Spina Plan BlockESPBNCT07404995
Analgesic Efficacy of Bilateral Erector Spinae Plane Block in Pediatric Tethered Cord Syndrome 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
Tethered Cord Syndrome is a developmental anomaly of neuroaxis characterized by stretching of the spinal cord and is diagnosed in the pediatric age group. Surgical release of the tight and tethered filum terminale is performed. Read more about this study
- Who is it for?
- Ages 1 year to 18 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
- 73 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Apr 2025to 15 Jan 2026
- 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 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Inclusion Criteria:Patients whose parents have given their consent to the study
- Patients aged 18 and under
- Patients with ASA (American Society of Anesthesiologists) physical status I, II, and III
- Pediatric patients who will undergo elective Tethered Cord Syndrome surgery
Exclusion Criteria:Patients whose parents did not consent to participate in the study
- Patients with ASA physical status IV and V
- Those using anticoagulant medications
- Allergy to local anesthetic drugs
- Patients with a history of gastrointestinal bleeding
- Those with infection in the area where the block is planned
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
About this study
Official title: Analgesic Efficacy of Bilateral Erector Spinae Plane Block in Pediatric Tethered Cord Syndrome Surgery: A Prospective, Randomized Controlled Trial
Tethered Cord Syndrome is a developmental anomaly of neuroaxis characterized by stretching of the spinal cord and is diagnosed in the pediatric age group. Surgical release of the tight and tethered filum terminale is performed. Intraoperative neurophysiological monitoring (IONM) is used to preserve functional nerve tissue and prevent postoperative neurological deficits. Total intravenous anesthesia (TIVA-TCI) with propofol and remifentanil is used as the anesthesia method to ensure accurate measurements. Postoperative pain is acute pain caused by surgical trauma and signal transmission in afferent neurons. Pediatric postoperative pain is associated with adverse behaviors, prolonged hospital stay, and impaired functional recovery. Although good progress has been made in pain management, ineffective postoperative pain management in children remains a global problem. Regional anesthesia is increasingly used in pediatric patients to provide postoperative analgesia and support intraoperative anesthesia. Ultrasound-guided erector spinae plane block (ESPB) is a new approach. First introduced in 2016 by Forero et al., ESPB is a novel regional anesthesia technique that blocks the branches of spinal nerves by injecting a local anesthetic into the fascial plane between the erector spinae muscle and the transverse process. The aim of our study was to reduce intraoperative anesthetic drug consumption, postoperative pain levels in the first 24 hours, the need for analgesics, and unwanted side effects associated with analgesics by applying bilateral ESPB in pediatric patients operated on for Tethered Cord Syndrome. Our hypothesis in this study is that bilateral ESPB reduces intraoperative anesthetic drug consumption and the need for postoperative analgesia in pediatric patients operated on for Tethered Cord Syndrome.
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
- TETHERED CORD SENDROME, ESPB, TCI
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 |
|---|---|---|
| UNDER ULTRASOUND GUİDANCE 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.
INTRAOPERATİVE ANESTHETİC DRUG CONSUMPTİON BY APPLYİNG BİLATERAL ESPB İN PEDİATRİC PATİENTS.
TOTAL PROPOFOL (MİLLİGRAM) and TOTAL REMİFENTANYL (MİCROGRAM)
Measured: İNTRAOPERATİVE
Secondary outcomes (1)
POSTOPERATIVE PAIN SCORES
POSTOPERATİVE PAİN SCORE (0: NONE, 100: VERY SEVERE)
Measured: POSTOPERATIVE SERVICE 0. MINUTE 30.MINUTE 12.HOURS 5. MINUTE 1. HOURS 24. HOURS 10. MINUTE 2.HOURS 15. MINUTE 4. HOURS 20. MINUTE 6.HOURS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start9 Apr 2025
- Primary completion1 Dec 2025
- Study completion15 Jan 2026
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
- 73 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
- NCT07404995
- Sponsor's protocol ID
- 2024-KAEK-13
- Acronym
- ESPB
- Status last verified
- Feb 2026
- First submitted
- 19 Jan 2026
- Last updated
- 12 Feb 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
Ali Gado A, Alsadek WM, Ali H, Ismail AA. Erector Spinae Plane Block for Children Undergoing Cardiac Surgeries via Sternotomy: A Randomized Controlled Trial. Anesth Pain Med. 2022 Apr 19;12(2):e123723. doi: 10.5812/aapm-123723. eCollection 2022 Apr.
PubMed 35991776
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Bilateral Erector Spinae Plane Block in Pediatric Tethered Cord Syndrome Surgery: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07404995
- Acronym / sponsor ID
- ESPB / 2024-KAEK-13
- Conditions
- Erector Spina Plan Block
- Keywords
- TETHERED CORD SENDROME, ESPB, TCI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 12 Feb 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.
Tethered Cord Syndrome is a developmental anomaly of neuroaxis characterized by stretching of the spinal cord and is diagnosed in the pediatric age group. Surgical release of the tight and tethered filum terminale is performed. Intraoperative neurophysiological monitoring (IONM) is used to preserve functional nerve tissue and prevent postoperative neurological deficits. Total intravenous anesthesia (TIVA-TCI) with propofol and remifentanil is used as the anesthesia method to ensure accurate measurements. Postoperative pain is acute pain caused by surgical trauma and signal transmission in afferent neurons. Pediatric postoperative pain is associated with adverse behaviors, prolonged hospital stay, and impaired functional recovery. Although good progress has been made in pain management, ineffective postoperative pain management in children remains a global problem. Regional anesthesia is increasingly used in pediatric patients to provide postoperative analgesia and support intraoperative anesthesia. Ultrasound-guided erector spinae plane block (ESPB) is a new approach. First introduced in 2016 by Forero et al., ESPB is a novel regional anesthesia technique that blocks the branches of spinal nerves by injecting a local anesthetic into the fascial plane between the erector spinae muscle and the transverse process. The aim of our study was to reduce intraoperative anesthetic drug consumption, postoperative pain levels in the first 24 hours, the need for analgesics, and unwanted side effects associated with analgesics by applying bilateral ESPB in pediatric patients operated on for Tethered Cord Syndrome. Our hypothesis in this study is that bilateral ESPB reduces intraoperative anesthetic drug consumption and the need for postoperative analgesia in pediatric patients operated on for Tethered Cord Syndrome.
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 |
|---|---|---|
| UNDER ULTRASOUND GUİDANCE 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
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
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 | UNDER ULTRASOUND GUİDANCE 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 | UNDER ULTRASOUND GUİDANCE ESPB GROUP |
Primary outcome
INTRAOPERATİVE ANESTHETİC DRUG CONSUMPTİON BY APPLYİNG BİLATERAL ESPB İN PEDİATRİC PATİENTS.
Time frame: İNTRAOPERATİVE
TOTAL PROPOFOL (MİLLİGRAM) and TOTAL REMİFENTANYL (MİCROGRAM)
1 secondary outcome
POSTOPERATIVE PAIN SCORES
Time frame: POSTOPERATIVE SERVICE 0. MINUTE 30.MINUTE 12.HOURS 5. MINUTE 1. HOURS 24. HOURS 10. MINUTE 2.HOURS 15. MINUTE 4. HOURS 20. MINUTE 6.HOURS
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 12 Feb 2026.
- Results publication: PubMed 35991776Ali Gado A, Alsadek WM, Ali H, Ismail AA. Erector Spinae Plane Block for Children Undergoing Cardiac Surgeries via Sternotomy: A Randomized Controlled Trial. Anesth Pain Med. 2022 Apr 19;12(2):e123723. doi: 10.5812/aapm-123723. eCollection 2022 Apr.
- 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
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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 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?
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 12 Feb 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?
INTRAOPERATİVE ANESTHETİC DRUG CONSUMPTİON BY APPLYİNG BİLATERAL ESPB İN PEDİATRİC PATİENTS. (time frame: İNTRAOPERATİVE). 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 NCT07404995, 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 12 Feb 2026.