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Not yet recruiting NCT06775418

Comparison Between Ultrasound Guided Erector Spinae Plane Block and Dexmedotomidine in Lumber Spine Surgeries.

No phase Interventional Analgesia, Postoperative

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: Ultrasound erector spinae plane block, dexamedotomidine infusion after induction of anesthesia.
Who it may be relevant to
Registry conditions: Analgesia, Postoperative. Basic parameters: 18 years — 50 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
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Ultrasound (US) guided Erector spinae plane block (ESPB) as a new trunchal fascial plane block technique was proposed in 2016. US guided ESPB has aroused the interest of many nerve block experts. The goal of this study is to evaluate the effect of US guided ESPB versus (VS) intravenous Dexmedotomidine on postoperative analgesia and intra operative hemodynamic parameters in lumbar spine surgeries. The aim of this study is to compare the efficacy of ESPB to intravenous Dexmedetomidine in patients who are undergoing elective lumber spine surgeries regarding the effect on postoperative analgesia and intra operative hemodynamic parameters.

Detailed description

The use of US guided ESPB in lumbar spine surgery has not been extensively studied in clinical research. Although there is limited research available, some studies have highlighted differences in the mechanism and effectiveness of the block in different regions of the erector spinae muscle. Some scholars question the practicability of US guided ESPB in lumbar surgery. This suggests that further investigation is needed to understand the practicality and potential benefits of using ultrasound-guided ESPB in lumbar spine surgery.

Dexmedetomidine, a highly selective α₂ receptor agonist, has a sympatholytic, sedative, amnestic and opioid sparing effect. It does not cause respiratory depression and can therefore be used as an adjuvant in certain clinical settings .

Interventions

  • Procedure Ultrasound erector spinae plane block
    Patients will be subdivided randomly into two groups (15 patients each) using computer generated random numbers with closed envelopes: Group U (15 patients):will receive bilateral US guided single shot ESPB, 30 ml of bupivacaine 0.25% on each side after induction of anesthesia.
  • Procedure dexamedotomidine infusion after induction of anesthesia
    Patients will be subdivided randomly into two groups (15 patients each) using computer generated random numbers with closed envelopes: Group D (15 patients):will receive the study drug infusion (Dexmedetomidine) after induction of anesthesia.

Primary outcome measures

  • (VAS) during the 1st 24 hours [Time frame: 24 HOURS]

Eligibility criteria

Inclusion criteria

  • ASA I and II patients. aged 18 to 50 years. 70 to 80 kg.

Exclusion criteria

  • patients under 18 years of age.
  • History of Allergic reactions to study drugs.
  • Opioid or analgesic abuse, and chronic treatment with opioids, or nonsteroidal anti-inflammatory drugs.
  • History of bleeding tendency or coagulopathy

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

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Egypt · 1 center
  • Faculty of Medicine — Cairo

Identifiers

NCT: NCT06775418 · MS61/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗