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Two Syringe Spinal Anesthesia Technique for Cesarean Section: A Simple Way to Achieve More Satisfactory Block and Less Hypotension

Primary Purpose

Cesarean Section

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
fentanyl
fentanyl
Hyperbaric bupivacaine
hyperbaric bupivacaine
Sponsored by
Dr. Soliman Fakeeh Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cesarean Section focused on measuring spinal anesthesia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Parturient at full term.
  • Must be elective cesarean section.
  • Must be uncomplicated pregnancy

Exclusion Criteria:

  • Body weight <50 kg or >90 kg
  • Height ˂150 cm or >170 cm.
  • Pre-eclampsia.
  • Any major systemic disease.
  • Contraindication to regional anesthesia.
  • Allergy to used medications.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    (S) separate.

    (M) mixed

    Arm Description

    fentanyl and hyperbaric bupivacaine (sequentially)

    fentanyl and hyperbaric bupivacaine.(mixed)

    Outcomes

    Primary Outcome Measures

    Number of parturients needed more analgesics (unsatisfactory block) using Ochsner Health System.
    incidence of hypotension

    Secondary Outcome Measures

    Full Information

    First Posted
    October 10, 2015
    Last Updated
    October 19, 2015
    Sponsor
    Dr. Soliman Fakeeh Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02577432
    Brief Title
    Two Syringe Spinal Anesthesia Technique for Cesarean Section: A Simple Way to Achieve More Satisfactory Block and Less Hypotension
    Official Title
    Two Syringe Spinal Anesthesia Technique for Cesarean Section: A Controlled Randomized Study of a Simple Way to Achieve More Satisfactory Block and Less Hypotension
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2013 (undefined)
    Primary Completion Date
    October 2014 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Dr. Soliman Fakeeh Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Background: Poor spinal anaesthesia block is common and is difficult to manage; so a technique to minimize its incidence is advisable. Hypotension is the commonest problem with spinal anesthesia. Multiple trials to prevent or combat hypotension using positional changes, fluid therapy and the use of vasopressors were tried. However, the drug choice and mode of administration as either bolus or infusion is still a matter of debate. Objectives: To compare the outcome of spinal injection of hyperbaric bupivacaine and fentanyl separately to standard injection of mixed fentanyl with hyperbaric bupivacaine. Design: A randomized, controlled clinical trial. Setting: Single medical center from 5/2013 to 10/2014. Patients & Methods: 124 parturient scheduled for elective cesarean section (CS) were randomly allocated into two groups, each 62 parturient: Group M received spinal anesthesia using 10 mg bupivacaine 0.5% premixed with 25 µg fentanyl in the same syringe and Group S received 25 µg fentanyl in one syringe and 10 mg bupivacaine 0.5% without barbotage in a second syringe. Intravenous fluid co-load with 15 ml/kg warm lactated ringer solution was started as fast drip during, and continued after spinal anesthesia. Patients were monitored for hemodynamic parameters, time of sensory onset and height of maximum sensory block, lower limb motor blockade was scored using modified Bromage scale and the frequency of side effects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cesarean Section
    Keywords
    spinal anesthesia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    124 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    (S) separate.
    Arm Type
    Active Comparator
    Arm Description
    fentanyl and hyperbaric bupivacaine (sequentially)
    Arm Title
    (M) mixed
    Arm Type
    Active Comparator
    Arm Description
    fentanyl and hyperbaric bupivacaine.(mixed)
    Intervention Type
    Drug
    Intervention Name(s)
    fentanyl
    Intervention Description
    Give 25 micro grams fentanyl intrathecal with one syringe. Then immediately give 10 mg hyperbaric bupivacaine intrathecally with an other syringe.
    Intervention Type
    Drug
    Intervention Name(s)
    fentanyl
    Intervention Description
    Mix 25 micro grams fentanyl with 10 mg hyperbaric bupivacaine in one syringe. Give them intrathecally.
    Intervention Type
    Drug
    Intervention Name(s)
    Hyperbaric bupivacaine
    Intervention Description
    Give 25 micro grams fentanyl intrathecal with one syringe. Then immediately give 10 mg hyperbaric bupivacaine intrathecally with an other syringe.
    Intervention Type
    Drug
    Intervention Name(s)
    hyperbaric bupivacaine
    Intervention Description
    Mix 25 micro grams fentanyl with 10 mg hyperbaric bupivacaine in one syringe. Give them intrathecally.
    Primary Outcome Measure Information:
    Title
    Number of parturients needed more analgesics (unsatisfactory block) using Ochsner Health System.
    Time Frame
    intraoperative
    Title
    incidence of hypotension
    Time Frame
    intraoperative

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Parturient at full term. Must be elective cesarean section. Must be uncomplicated pregnancy Exclusion Criteria: Body weight <50 kg or >90 kg Height ˂150 cm or >170 cm. Pre-eclampsia. Any major systemic disease. Contraindication to regional anesthesia. Allergy to used medications.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amr A Keera, MD
    Organizational Affiliation
    Dr. Benha Faculty of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Two Syringe Spinal Anesthesia Technique for Cesarean Section: A Simple Way to Achieve More Satisfactory Block and Less Hypotension

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