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

NCT06775418 | Not Yet Recruiting DMC

• 1 other identifier: MS61/2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Analgesia, Postoperative

Outcome Measures

Primary Outcomes (1)

• (VAS) during the 1st 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

Study Arms (2)

group U

EXPERIMENTAL

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

group D

EXPERIMENTAL

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

Procedure: dexamedotomidine infusion after induction of anesthesia

Interventions

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.

group U

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.

group D

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine

Cairo, Egypt

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ahmed El-Dolah, lecturer of Anesthesia

CONTACT

+201001803705; a_wagih82@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anasthesia,intensive care and pain management

Study Record Dates

• First Submitted: January 5, 2025
• First Posted: January 15, 2025
• Study Start: January 1, 2025
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)