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Effect of Slow Injection of Fentanyl on the Incidence of Spinal Anesthesia Induced Itching in Cesarean Section

Primary Purpose

Itching

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
(R) Rapid spinal fentanyl injection
(S) Slow spinal fentanyl injection
Sponsored by
Dr. Soliman Fakeeh Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Itching

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Elective and emergency cesarean section parturient.

Exclusion Criteria:

  • Allergy to any medications, contraindications to spinal anesthesia, those who requested sedation, presence of skin lesions that may cause itching and opioid addiction.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    (R) Rapid spinal fentanyl injection

    (S) Slow spinal fentanyl injection

    Arm Description

    Patients will receive 25 mic fentanyl spinal ( after dilution with 2.5 ml CSF) in 15 seconds then 10 mg hyperbaric bupivacaine.

    Patients will receive 25 mic fentanyl spinal ( after dilution with 2.5 ml CSF) in 90 seconds then 10 mg hyperbaric bupivacaine.

    Outcomes

    Primary Outcome Measures

    ( 0 - 10) Itching scale

    Secondary Outcome Measures

    Satisfactory Block ( no pain, Pain relieved by opioids or pain needs general anesthesia

    Full Information

    First Posted
    October 19, 2016
    Last Updated
    September 5, 2020
    Sponsor
    Dr. Soliman Fakeeh Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02951806
    Brief Title
    Effect of Slow Injection of Fentanyl on the Incidence of Spinal Anesthesia Induced Itching in Cesarean Section
    Official Title
    Effect of Slow Injection of Fentanyl on the Incidence of Spinal Anesthesia Induced Itching in Cesarean Section
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2016 (Actual)
    Primary Completion Date
    March 2019 (Actual)
    Study Completion Date
    June 2020 (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
    Pruritus is a troublesome side-effect of neuraxial (epidural and intrathecal) opioids. Sometimes it may be more unpleasant than pain itself. The incidence of pruritus is 83% in postpartum patients and 69% in non-pregnant patients including males and females (1). Some researchers concluded that slow injection rate of hyperbaric bupivacaine may be a simple and effective way to reduce the incidence and severity of hypotension during cesarean section under spinal anesthesia (2). In this new research I want to investigate the effect of slow injection of fentanyl separately, in spinal anesthesia for cesarean section, on the incidence of itching In this double blind randomized study two hundred parturient will be randomly allocated in to two groups; Group (R) will receive 25 mic fentanyl spinal ( after dilution with 2.5 ml CSF) in 15 seconds. Group (S) will receive the same dose in 90 seconds All parturient will receive 10 mg bupivacaine in 45 min after fentanyl. Exclusion criteria will be those with allergy to any medications, contraindications to spinal anesthesia, those who requested sedation, presence of skin lesions that may cause itching and opioid addiction. Parturient will be monitored regarding the incidence of itching, hypotension, nausea and vomiting. Onset and level of sensory block will also be recorded.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    215 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    (R) Rapid spinal fentanyl injection
    Arm Type
    Active Comparator
    Arm Description
    Patients will receive 25 mic fentanyl spinal ( after dilution with 2.5 ml CSF) in 15 seconds then 10 mg hyperbaric bupivacaine.
    Arm Title
    (S) Slow spinal fentanyl injection
    Arm Type
    Active Comparator
    Arm Description
    Patients will receive 25 mic fentanyl spinal ( after dilution with 2.5 ml CSF) in 90 seconds then 10 mg hyperbaric bupivacaine.
    Intervention Type
    Drug
    Intervention Name(s)
    (R) Rapid spinal fentanyl injection
    Intervention Description
    Patients will receive 25 micrograms fentanyl ( after dilution with 2.5 ml CSF) in 20 seconds then 10 mg hyperbaric bupivacaine.
    Intervention Type
    Drug
    Intervention Name(s)
    (S) Slow spinal fentanyl injection
    Intervention Description
    Patients will receive 25 micrograms fentanyl ( after dilution with 2.5 ml CSF) in 90 seconds then 10 mg hyperbaric bupivacaine.
    Primary Outcome Measure Information:
    Title
    ( 0 - 10) Itching scale
    Time Frame
    60 min
    Secondary Outcome Measure Information:
    Title
    Satisfactory Block ( no pain, Pain relieved by opioids or pain needs general anesthesia
    Time Frame
    60 min
    Other Pre-specified Outcome Measures:
    Title
    Hypotension ( yes or no)
    Time Frame
    60 minutes

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Elective and emergency cesarean section parturient. Exclusion Criteria: Allergy to any medications, contraindications to spinal anesthesia, those who requested sedation, presence of skin lesions that may cause itching and opioid addiction.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amr A Keera
    Organizational Affiliation
    Doctor Soliman Fakeeh Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    I hope to publish the data in a respected journal.

    Learn more about this trial

    Effect of Slow Injection of Fentanyl on the Incidence of Spinal Anesthesia Induced Itching in Cesarean Section

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