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Lumbar Epidural Analgesia Versus Local Anesthesia With Dexmedetomidine Infusion in Endoscopic Lumbar Discectomy

Primary Purpose

Lumbar Disc Herniation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dexmedetomidine Hydrochloride 'Precedex' combined with
Lumbar epidural analgesia with Bupivacaine 0.25% 'Sunnypivacaine'
General anesthesia
Local infiltration with Lidocaine HCL 1%'Debocaine'
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients American Society of anesthesiologists' physical status (ASA) I to II. Aged 18 to 50 years. Both sexes. Exclusion Criteria: Spinal malformation Recurrent LDH Multi segment LDH Patients younger than 18 years or older than 50 years Patients with hypersensitivity to one of the used drugs

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Group A

    Group B

    Group Con

    Arm Description

    will receive local anesthesia with dexmedetomidine infusion

    will receive epidural analgesia

    will receive general anesthesia

    Outcomes

    Primary Outcome Measures

    Visual Analogue Scale (VAS), A score from 0 -10 where 10indicates the worst pain possible
    The first outcome is to compare the VAS preoperative, intraoperative for group A, B and 1 hour postoperative for group A, B and Con
    Heart rate
    Comparing the Heart rate ( Heart beats per minute) for the 3 groups every 30 minutes intraoperative and every hour postoperative for 6 hours
    Postoperative anesthetic complications
    Assess and compare postoperative anesthetic complications postoperative, 1 day postoperative and 2 days postoperative
    Satisfaction rate of anesthesia
    To compare satisfaction rate of anesthesia 1 hour postoperative Using the .The Heidelberg Peri-anaesthetic Questionnaire
    Systolic and Diastolic Blood pressure
    Comparing the systolic and diastolic Blood Pressure in mmHG for the 3 groups every 30 minutes intraoperative and every hour postoperative for 6 hours

    Secondary Outcome Measures

    Full Information

    First Posted
    April 19, 2023
    Last Updated
    April 29, 2023
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05850455
    Brief Title
    Lumbar Epidural Analgesia Versus Local Anesthesia With Dexmedetomidine Infusion in Endoscopic Lumbar Discectomy
    Official Title
    A Comparative Study Between Lumbar Epidural Analgesia Versus Local Analgesia With Dexmedetomidine Infusion in Endoscopic Lumbar Discectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2023 (Anticipated)
    Primary Completion Date
    November 2023 (Anticipated)
    Study Completion Date
    November 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To compare between local anesthesia combined with intravenous Dexmedetomidine and epidural analgesia as regard the effectiveness and patient satisfaction during percutaneous transforaminal endoscopic discectomy.
    Detailed Description
    Percutaneous transforaminal endoscopic discectomy. under LA is recommended in consideration of safety. Under LA, patients keep conscious during the process of PTED, and the surgeon can obtain feedback directly from the patients if the nerve is interfered. Dexmedetomidine, a highly selective alpha 2 adrenoreceptor agonist, has unique characteristics in providing sedation and analgesia. Due to its central sympatholytic action, Dexmedetomidine produces dose-dependent sedation, antinociception and anxiolysis. Epidural anesthesia is another major method which can keep patients awake during surgery and the surgeons can check the function of the nerve from the maintained motor function of patients' lower limbs

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lumbar Disc Herniation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    78 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Experimental
    Arm Description
    will receive local anesthesia with dexmedetomidine infusion
    Arm Title
    Group B
    Arm Type
    Experimental
    Arm Description
    will receive epidural analgesia
    Arm Title
    Group Con
    Arm Type
    Experimental
    Arm Description
    will receive general anesthesia
    Intervention Type
    Drug
    Intervention Name(s)
    Dexmedetomidine Hydrochloride 'Precedex' combined with
    Intervention Description
    Dexmedetomidine Hydrochloride which is an Alfa 2 receptor agonist
    Intervention Type
    Procedure
    Intervention Name(s)
    Lumbar epidural analgesia with Bupivacaine 0.25% 'Sunnypivacaine'
    Intervention Description
    The epidural insertion point will be 2 segments upper than the surgical procedure level, 10 ml of Bupivacaine 0.25% will be injected in the epidural space to adjust the sensory level
    Intervention Type
    Procedure
    Intervention Name(s)
    General anesthesia
    Intervention Description
    Propofol 2-3 mg/kg'Diprivan 1%', Fentanyl 'Fentanyl' 2 μg/kg, and Cisatracurium 'Cisatracure' 0.2 mg/kg will be administered to facilitate endotracheal intubation, and ventilation will be controlled to maintain the end-tidal carbon dioxide (CO2) between 32-38 mmHg, to maintain anesthesia, 2-3% Sevoflurane 'Sevoflurane', and 0.05 mg/kg of the muscle relaxant Cisatracurium will be added at 40-minute intervals according to the conditions of the operation. No other medication will be administered
    Intervention Type
    Drug
    Intervention Name(s)
    Local infiltration with Lidocaine HCL 1%'Debocaine'
    Intervention Description
    Lidocaine 1% which is a local analgesic as local infiltration
    Primary Outcome Measure Information:
    Title
    Visual Analogue Scale (VAS), A score from 0 -10 where 10indicates the worst pain possible
    Description
    The first outcome is to compare the VAS preoperative, intraoperative for group A, B and 1 hour postoperative for group A, B and Con
    Time Frame
    4 hours
    Title
    Heart rate
    Description
    Comparing the Heart rate ( Heart beats per minute) for the 3 groups every 30 minutes intraoperative and every hour postoperative for 6 hours
    Time Frame
    9 hours
    Title
    Postoperative anesthetic complications
    Description
    Assess and compare postoperative anesthetic complications postoperative, 1 day postoperative and 2 days postoperative
    Time Frame
    2 days
    Title
    Satisfaction rate of anesthesia
    Description
    To compare satisfaction rate of anesthesia 1 hour postoperative Using the .The Heidelberg Peri-anaesthetic Questionnaire
    Time Frame
    1 hour
    Title
    Systolic and Diastolic Blood pressure
    Description
    Comparing the systolic and diastolic Blood Pressure in mmHG for the 3 groups every 30 minutes intraoperative and every hour postoperative for 6 hours
    Time Frame
    9 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients American Society of anesthesiologists' physical status (ASA) I to II. Aged 18 to 50 years. Both sexes. Exclusion Criteria: Spinal malformation Recurrent LDH Multi segment LDH Patients younger than 18 years or older than 50 years Patients with hypersensitivity to one of the used drugs
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Riham Fa Galal, MD
    Phone
    01022739211
    Ext
    +2
    Email
    Rihamfathygalal@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Lumbar Epidural Analgesia Versus Local Anesthesia With Dexmedetomidine Infusion in Endoscopic Lumbar Discectomy

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