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

January 9, 2025 updated by: Ahmed wagih Ezzat deusouky, Ain Shams University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ahmed El-Dolah, lecturer of Anesthesia
  • Phone Number: +201001803705
  • Email: a_wagih82@yahoo.com

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group U
Group (U) will receive bilateral US guided single shot ESPB, 30 ml of bupivacaine 0.25% on each side after induction of anesthesia.
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.
Experimental: group D
Group (D)will receive the study drug infusion (Dexmedetomidine) 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(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.
24 HOURS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

January 5, 2025

First Submitted That Met QC Criteria

January 9, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 9, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS61/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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