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

NCT ID: NCT06775418

Last Updated: 2025-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-31

Study Completion Date

2025-04-30

Brief Summary

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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

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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 .

Conditions

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Analgesia, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Ultrasound erector spinae plane block

Intervention Type 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.

group D

Group (D)will receive the study drug infusion (Dexmedetomidine) after induction of anesthesia.

Group Type EXPERIMENTAL

dexamedotomidine infusion after induction of anesthesia

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed wagih Ezzat deusouky

lecturer of anasthesia,intensive care and pain management

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Ahmed El-Dolah, lecturer of Anesthesia

Role: CONTACT

+201001803705

Facility Contacts

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ahmed lecturer of Anesthesia

Role: primary

+201001803705

Other Identifiers

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MS61/2024

Identifier Type: -

Identifier Source: org_study_id

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