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NCT Number: NCT06775418

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

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.

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Key information

Conditions

Analgesia, Postoperative Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound erector spinae plane block

Procedure

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.

dexamedotomidine infusion after induction of anesthesia

Procedure

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 outcomes

  1. (VAS) during the 1st 24 hours

    Time frame: 24 HOURS

    Pain will be assessed on admission and at 2, 4, 8, 12 and 24 hours at rest and with passive flexion of hip and knee joint using visual analogue scale (VAS) ranging from 0 for no pain to 10 for worst pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed El-Dolah, lecturer of Anesthesia

CONTACT

[email protected]

+201001803705

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 15, 2025
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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