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Completed

NCT Number: NCT07537647

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bursa, 16310, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • 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

Exclusion criteria

  • • 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

Treatment and study plan

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.

Other names: ESPB BLOCK

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.

Other names: PLANE BLOCKS

Primary outcomes

  1. 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.

Secondary outcomes

  1. Evaluation of postoperative analgesic consumption and hospital stay duration.

    Time frame: Postoperative 24-hour period

    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).

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

The Effect of Bilateral Erector Spina Plan Block Performed After Lumbar Spinal Stabilization Surgery on Postoperative Patient Recovery and Pain

Acronym: ESPB

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 17, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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