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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07537647
Acronym
ESPB
Enrollment
50
Registered
2026-04-17
Start date
2024-09-01
Completion date
2025-05-01
Last updated
2026-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erector Spina Plan Block

Keywords

ESPB, spine surgery, postoperative analgesia

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.

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.

Interventions

DEVICEUNDER ULTRASOUND GUİDANCE 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.

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

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.

Sponsors

Bursa Yuksek Ihtisas Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
POSTOPERATIVE PAIN SCORESThe 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

MeasureTime frameDescription
Evaluation of postoperative analgesic consumption and hospital stay duration.Postoperative 24-hour periodAs 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).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 18, 2026