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Effectiveness of Combining Erector Spinea Block With Non Opioid Infusions as Opioid Free Anesthesia in Spine Surgeries.

Sponsor
Ain Shams University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05850468
Collaborator
(none)
140
Enrollment
1
Location
2
Arms
6
Anticipated Duration (Months)
23.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

opioid free anesthesia consists of combination of pharmacological and non pharmacological modalities that target different pathways of pain mechanism. combining myofascial plane blocks with infusion of adjuvants such as lidocaine or dexmedetomidine can offer equivalent intraoperative hemodynamic stability compared to that of opioid with better pain control postoperatively. this study will investigate the efficacy of combined erector spina block with lidocaine and dexmedetomidine infusion as opioid sparing anesthesia in spine surgeries

Condition or Disease Intervention/Treatment Phase
  • Drug: fentanyl infusion after general anesthesia and erector spinea block
  • Drug: lidocaine 2% and dextometometidine infusion after general anesthesia and erector spinea block
 N/A

Detailed Description

patients who will undergo spine surgery will be allocated into two groups. after general anesthesia, bilateral erector spine block will be applied in both groups. group A will have intraoperative fentanyl infusion and group B will have lidocaine and dexmedetomidine infusion in 50 ml syringe till end of surgery

Study Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Assistant Professor of Anesthesia, Intensive Care and Pain Management
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: traditinal balanced anesthesia

fentanyl infusion after general anesthesia and erector spinea block

Drug: fentanyl infusion after general anesthesia and erector spinea block
intraoperative opioid infusion in active comparative group
Other Names:
  • opioid infusion

    		•
    Experimental: opioid free anesthesia

    lidocaine and dextometidine infusion after general anesthesia and erector spinea block

    Drug: lidocaine 2% and dextometometidine infusion after general anesthesia and erector spinea block
    intraoperative non opioid infusion in experimental group
    Other Names:
  • lidocaine 2% and precedex infusion

    		•

    Outcome Measures

    Primary Outcome Measures

    1. number of patients (percentage) having intraoperative systolic hypertension [during operation(intraoperatively)]

      blood pressure more than 160 mmhg

    2. number of patients(percentage) having tachycardia [during operation(intraoperatively)]

      heart rate more than 100 beat /minute

    Secondary Outcome Measures

    1. VAS score [every 30 minutes for 2 hours postoperatively]

      score from 0 to 10, 0 is no pain and 10 the worst pain

    2. incidence of bradycardia [intraoperatively]

      heart rate less than 45 beat per minute

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • spine surgery ASAI,II
    Exclusion Criteria:
    • revision surgery hypotension bradycardia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ainshams hospitals Cairo Egypt 11591

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    • Principal Investigator: sanaa wasfy, professor, assistant professor of anesthesia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT05850468
    Other Study ID Numbers:
    • MS81/2023
    First Posted:
    May 9, 2023
    Last Update Posted:
    May 9, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Ain Shams University
    multimodal analgesia, regional blocks, spine surgeries
    Additional relevant MeSH terms:
    Lidocaine
    Fentanyl
    Anesthetics

    Study Results

    No Results Posted as of May 9, 2023