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Intrathecal Additives for Spinal Anaesthesia in Elective Caesarean Sections

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
intrathecal Magnesium
intrathecal dexamthasone
intrathecal dexmedetomidine
Sponsored by
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain, Postoperative

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists classII-III adult female patient (age :18 -40 years old )
  • Elective cesarean section under spinal anaesthesia
  • Gestational age > 37 weeks
  • BMI less than 30 kg/m2

Exclusion Criteria:

  • Patient refusal
  • unable to give consent
  • age < 18 or > 40
  • BMI more than 30 kg/m2
  • known allergy to the study medication
  • coagulopathies or on anticoagulant medications
  • diabetic neuropathy
  • patients with psychiatric disorders

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    magnesium intrathecal

    dexamethasone intrathecal

    dexmedetomidine intrathecal

    Arm Description

    Outcomes

    Primary Outcome Measures

    analgesic effect
    duration of sensory block

    Secondary Outcome Measures

    Full Information

    First Posted
    February 5, 2021
    Last Updated
    February 9, 2021
    Sponsor
    Benha University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04747171
    Brief Title
    Intrathecal Additives for Spinal Anaesthesia in Elective Caesarean Sections
    Official Title
    A Comparative Study of Postoperative Analgesia of Different Intrathecal Additives for Spinal Anaesthesia in Elective Caesarean Sections
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2021 (Anticipated)
    Primary Completion Date
    June 2021 (Anticipated)
    Study Completion Date
    July 2021 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    we designed this randomized, single -blind, prospective clinical study to test postoperative analgesia of three intrathecal additives in elective caesarean sections which are magnesium, dexamethasone and dexmedetomidine.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Postoperative

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    105 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    magnesium intrathecal
    Arm Type
    Active Comparator
    Arm Title
    dexamethasone intrathecal
    Arm Type
    Active Comparator
    Arm Title
    dexmedetomidine intrathecal
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    intrathecal Magnesium
    Intervention Description
    intrathecal adjuvants to bupivacaine
    Intervention Type
    Drug
    Intervention Name(s)
    intrathecal dexamthasone
    Intervention Description
    intrathecal adjuvants to bupivacaine
    Intervention Type
    Drug
    Intervention Name(s)
    intrathecal dexmedetomidine
    Intervention Description
    intrathecal adjuvants to bupivacaine
    Primary Outcome Measure Information:
    Title
    analgesic effect
    Description
    duration of sensory block
    Time Frame
    Up to 24 hours after surgery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: American Society of Anesthesiologists classII-III adult female patient (age :18 -40 years old ) Elective cesarean section under spinal anaesthesia Gestational age > 37 weeks BMI less than 30 kg/m2 Exclusion Criteria: Patient refusal unable to give consent age < 18 or > 40 BMI more than 30 kg/m2 known allergy to the study medication coagulopathies or on anticoagulant medications diabetic neuropathy patients with psychiatric disorders

    12. IPD Sharing Statement

    Learn more about this trial

    Intrathecal Additives for Spinal Anaesthesia in Elective Caesarean Sections

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