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Efficacy of the erector spinae plane (ESP) block for Post-op Pain With C-arm fluoroscopy guidance in posterior lumbar spinal Fusion surgery

Determining the effectiveness of using the Erector Spinae Plane Block method under the guidance of C-arm Fluoroscopy on post-op pain based on the Visual Analogue Scale criteria in patients undergoing Posterior Lumbar Spinal Fusion Surgery and the factors affecting it in comparison to the placebo group. compared to the group that receives the anesthetic cocktail containing the composition (Ropivacaine 5mg/ml + Dexamethasone + Normal Saline)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230317057745N1
Enrollment
80
Registered
2023-04-29
Start date
2023-09-23
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

Back pain caused by stenosis of the lumbar canal or intervertebral disc. Other thoracic, thoracolumbar and lumbosacral intervertebral disc displacement

Interventions

Intervention 1: Intervention group: injection of one dose of anesthetic cocktail including 15 cc of ropivacaine 0.5 + 5 cc of normal saline + 8 mg of dexamethasone in the lateral 1/3 of the L4 vertebr

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Obtaining informed consent from the patient to enter the study 2) Age between 18-70 3) According to the indications mentioned in the article by Grob D and her colleagues in 1998, patients who are candidates for fixation through screw insertion include?) Segmental dysfunction?) Lumbar Spinal Stenosis?) Disc related syndrome 4) Patients who will be Fused by Pedicular screw along two or three level from L1 to S1 vertebra Patients who will classified into groups 1 to 3 according to The American Society of Anesthesiologists (ASA) physical status classification system

Exclusion criteria

Exclusion criteria: Severe liver or kidney disease History of psychiatric illness or use of medications related to psychiatric illness Use of anticoagulants or corticosteroids Known hypersensitivity to local anesthetics pregnancy Age below 18 years or above 70 years History of opioid use History of previous surgery on the lumbar region 9) Patients who are not extubated in the operating room Surgical site infection BMI>35 Dural tear Post Operative Motor deficit Root Avulsion Receiving MS medicine or pethidine at the end of the procedure Surgery due to trauma Surgery due to infection Surgery due to tumor Contrast allergic reaction

Design outcomes

Primary

MeasureTime frame
Pain severity based on Visual Analogue Scale. Timepoint: 4-12-24-48 hours after patient enters recovery. Method of measurement: VAS score.

Secondary

MeasureTime frame
The dose of opioid used. Timepoint: 4-12-24-48 hours after patient enters recovery. Method of measurement: Patient Files.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactPedram Jahangiri

Tehran University of Medical Sciences

jahangiriiiipedram@gmail.com+98 21 8856 3128

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026