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Recruiting NCT07180940

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

Phase IV Interventional Spine Disease Spinal Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 0.9%NaCl, Dexamethasone 4mg, Dexmedetomidine.
Who it may be relevant to
Registry conditions: Spine Disease, Spinal Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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.

Detailed 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.

Interventions

  • Drug 0.9%NaCl
    2 x 20ml 0.2% ropivacaine with 2ml of 0.9% NaCl
  • Drug Dexamethasone 4mg
    2 x 20ml 0.2% ropivacaine with 2mg of dexamethasone
  • Drug Dexmedetomidine
    2 x 20ml 0.2% ropivacaine with 25ug Dexmedetomidine

Primary outcome measures

  • Total opioid Consuption [Time frame: 48 hours after surgery]
Secondary outcome measures (12)
  • NRS [Time frame: 4 hours after surgery]
  • NRS [Time frame: 8 hours after surgery]
  • NRS [Time frame: 12 hours after surgery]
  • NRS [Time frame: 24 hours after surgery]
  • NRS [Time frame: 48 hours after surgery]
  • Nerve injury [Time frame: 12 hours after surgery]
  • Nerve injury [Time frame: 24 hours after surgery]
  • Nerve injury [Time frame: 48 hours after surgery]
  • adverce effects [Time frame: 48 hours after surgery]
  • Time to first rescue analgesia [Time frame: 48 hours after surgery]
  • blood glucose [Time frame: 12 hours after surgery]
  • blood glucose [Time frame: 24 hours after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Poland · 1 center
  • Poznan University of Medical Sciences — Poznan

Identifiers

NCT: NCT07180940 · 01/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗