The Effect of bılateral Erector spına Plan Block on postoperatıve paın ın spınal Surgery

NCT07537647 | Completed

• 1 other identifier: BUUKAEK-2024-4/4
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Erector Spina Plan Block

Keywords

ESPB; spine surgery; postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• POSTOPERATIVE PAIN SCORES

  Pain will be assessed using the Numerical rating scale (NRS) score at postoperatively.

  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.

  Postoperative 24-hour period

Study Arms (1)

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.

Device: UNDER ULTRASOUND GUİDANCE ESPB BLOCK; Procedure: PROCEDURE/SURGERY: ERECTOR SPİNAE (ESP) BLOCK WİTH BUPİVACAİNE

Interventions

UNDER ULTRASOUND GUİDANCE ESPB BLOCK DEVICE

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.

Also known as: ESPB BLOCK

ESPB GROUP

PROCEDURE/SURGERY: ERECTOR SPİNAE (ESP) BLOCK WİTH BUPİVACAİNE PROCEDURE

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.

Also known as: PLANE BLOCKS

ESPB GROUP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Bursa yüksek ihtisas eğitim ve araştırma hastanesi BURSA, Bursa, Türkiye, BURSA, Bursa 16310

Bursa, Bursa, 16310, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 37572144 RESULT

MeSH Terms

Interventions

Parapsychology; Dental Occlusion; Bupivacaine

Intervention Hierarchy (Ancestors)

Behavioral Sciences; Behavioral Disciplines and Activities; Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 17, 2026
• Study Start: September 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)