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Comparison of Perineural Dexamethasone Versus Dexmedetomidine as Adjuvants to Erector Spinae Plane Block in Lumbar Spine Surgery: A Randomized, Double-blind, Controlled Trial

Comparison of Perineural Dexamethasone Versus Dexmedetomidine as Adjuvants to Erector Spinae Plane Block in Lumbar Spine Surgery: A Randomized, Double-blind, Controlled Trial

Recruiting
18 years and older
All
Phase 4

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Overview

This clinical study aims to determine which of two medications-dexamethasone or dexmedetomidine-works better and is safer when used together with a local anesthetic (ropivacaine) in a type of nerve block called the erector spinae plane block (ESPB). This block helps reduce pain after lumbar spine surgery.

Description

All participants will receive general anesthesia for surgery and, in addition, a nerve block on both sides of the lower back. The nerve block will be done with ultrasound guidance and will include ropivacaine plus either dexamethasone or dexmedetomidine. Patients will be randomly assigned to one of these two groups, and neither the patient nor the doctors checking pain after surgery will know which medication was used.

The main goal is to see how much opioid pain medicine patients need during the first 24 and 48 hours after surgery. Other things we will look at include how strong the pain is, how soon pain relief is necessary, if there are any side effects like nausea or low blood pressure, and if there are any complications related to the block.

This study will help doctors choose the best option to manage pain after spine surgery while reducing the need for opioids and their side effects.

Eligibility

Inclusion Criteria:

  • Adults aged 18 to N/A (no limit)
  • Scheduled for elective lumbar spine surgery (e.g., decompression or fusion) via posterior approach
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Body weight ≥ 50 kg
  • Ability to provide written informed consent
  • Expected postoperative hospitalization of at least 48 hours

Exclusion Criteria:

  • Known allergy or contraindication to ropivacaine, dexamethasone, or dexmedetomidine
  • Infection at or near the site of block placement
  • Coagulation disorders or current use of anticoagulant therapy (not discontinued per guidelines)
  • Chronic opioid use or opioid dependence
  • Neurological or psychiatric disorders interfering with pain assessment
  • Diabetes mellitus with poorly controlled glycemia (e.g., HbA1c > 8%)
  • Severe hepatic or renal dysfunction
  • Body mass index (BMI) > 40 kg/m²
  • Pregnancy or breastfeeding
  • Refusal or inability to cooperate with the study protocol

Study details
    Spine Disease
    Spinal Diseases

NCT07180940

Poznan University of Medical Sciences

15 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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