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Labour Analgesia; Comparing a Combinations of Either Fentanyl or Bupivacaine With Intrathecal Morphine

Primary Purpose

Labor Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intrathecal morphine with fentanyl
Intrathecal morphine with bupivacaine
Sponsored by
Makerere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Labor Pain focused on measuring Labour analgesia, Intrathecal morphine, Bupivacaine, Fentanyl

Eligibility Criteria

14 Years - 60 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Parturients with singleton pregnancy
  • Emancipated minors

Exclusion Criteria:

  • Those who declined.
  • Parturients with any identified complication of labour like preeclampsia, severe cardiac disease or previous operative delivery.
  • Sepsis or wound at site of spinal injection.
  • Allergy to any of the study drugs elicited from history.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intrathecal morphine with fentanyl

    Intrathecal morphine with bupivacaine

    Arm Description

    Single shot of intrathecal morphine 100mcg mixed with 25mcg of fentanyl and filled up to make a 2ml solution. This would then be injected into the subarachnoid space through L2-3 or L3-4 following standard procedures.

    Single shot of intrathecal morphine 100mcg mixed with 2.5mg of spinal bupivacaine and filled up to make a 2ml solution.This would then be injected into the subarachnoid space through L2-3 or L3-4 following standard procedures.

    Outcomes

    Primary Outcome Measures

    Duration of analgesia
    Monitoring the level of pain by the visual analogue scale to determine the total duration of analgesia in hours starting 5 min after drug administration

    Secondary Outcome Measures

    APGAR score
    The effect of the drugs to the fetus shall be determined by proxy from the APGAR scores of the baby determined at 1 minute and then at 5 minutes. Poor APGAR scores are those equal or less than seven (7).
    Maternal side effects (composite)
    Maternal side effects including pruritis, urinary retention, high Bromage score, nausea and vomiting, abnormal blood pressure and pulse rate will be ascertained 24 hours after delivery.

    Full Information

    First Posted
    July 7, 2015
    Last Updated
    July 12, 2015
    Sponsor
    Makerere University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02498171
    Brief Title
    Labour Analgesia; Comparing a Combinations of Either Fentanyl or Bupivacaine With Intrathecal Morphine
    Official Title
    Evaluation Of Efficacy And Safety Of Labour Analgesia By Intrathecal Morphine With Fentanyl Compared To Morphine With Bupivacaine In Mulago Hospital: A Double-blinded Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    March 2014 (Actual)
    Study Completion Date
    March 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Makerere University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study is aimed at evaluating single short spinal technique as a form of labour analgesia in a setting where more expensive and labor intensive techniques are not feasible.The study will examine the safety and efficacy of two drug combinations (intrathecal morphine+fentanyl vs intrathecal morphine+bupivacaine) through a randomized control trial. The investigators hypothesize that a single shot of either intrathecal morphine plus fentanyl or intrathecal morphine plus bupivacaine achieve analgesia and are safe in parturients experiencing normal labour.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Labor Pain
    Keywords
    Labour analgesia, Intrathecal morphine, Bupivacaine, Fentanyl

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    138 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intrathecal morphine with fentanyl
    Arm Type
    Experimental
    Arm Description
    Single shot of intrathecal morphine 100mcg mixed with 25mcg of fentanyl and filled up to make a 2ml solution. This would then be injected into the subarachnoid space through L2-3 or L3-4 following standard procedures.
    Arm Title
    Intrathecal morphine with bupivacaine
    Arm Type
    Active Comparator
    Arm Description
    Single shot of intrathecal morphine 100mcg mixed with 2.5mg of spinal bupivacaine and filled up to make a 2ml solution.This would then be injected into the subarachnoid space through L2-3 or L3-4 following standard procedures.
    Intervention Type
    Drug
    Intervention Name(s)
    Intrathecal morphine with fentanyl
    Other Intervention Name(s)
    Morphine Sulphate 10mg/ml, Ampoule 1ml,Martindale Hong Kong, Fentanyl Citrate 0.05mg/ml, Ampoule 2ml,Martindale Hong Kong
    Intervention Description
    Parturients in this arm underwent a single shot spinal following standard procedure. the drug mixture was then introduced into the subarachnoid space following free flow of csf. the parturient was the monitored fo labour progression using the standard partogram, vital signs and the visual analogue scale score for pain recorded every 5 min. The fetus was monitored with an ultrasonic aided fetal Doppler until delivery
    Intervention Type
    Drug
    Intervention Name(s)
    Intrathecal morphine with bupivacaine
    Other Intervention Name(s)
    Morphine Sulphate 10mg/ml, Ampoule 1ml, Martindale Hong Kong, sesorcaine 0.5%, Ampoule 4ml, Astrazeneca
    Intervention Description
    Parturients in this arm underwent a single shot spinal following standard procedure. the drug mixture was then introduced into the subarachnoid space following free flow of csf. the parturient was the monitored fo labour progression using the standard partogram, vital signs and the visual analogue scale score for pain recorded every 5 min. The fetus was monitored with an ultrasonic aided fetal Doppler until delivery
    Primary Outcome Measure Information:
    Title
    Duration of analgesia
    Description
    Monitoring the level of pain by the visual analogue scale to determine the total duration of analgesia in hours starting 5 min after drug administration
    Time Frame
    10 hours
    Secondary Outcome Measure Information:
    Title
    APGAR score
    Description
    The effect of the drugs to the fetus shall be determined by proxy from the APGAR scores of the baby determined at 1 minute and then at 5 minutes. Poor APGAR scores are those equal or less than seven (7).
    Time Frame
    6 minutes
    Title
    Maternal side effects (composite)
    Description
    Maternal side effects including pruritis, urinary retention, high Bromage score, nausea and vomiting, abnormal blood pressure and pulse rate will be ascertained 24 hours after delivery.
    Time Frame
    34 hours
    Other Pre-specified Outcome Measures:
    Title
    Degree of satisfaction
    Description
    Mothers would be asked if they were satisfied with their pain control during labor and if they would recommend to others
    Time Frame
    24 hours after delivery
    Title
    Time of onset of analgesia
    Description
    Parturients would be monitored for when relief from pain was first felt.
    Time Frame
    After drug administartion

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Parturients with singleton pregnancy Emancipated minors Exclusion Criteria: Those who declined. Parturients with any identified complication of labour like preeclampsia, severe cardiac disease or previous operative delivery. Sepsis or wound at site of spinal injection. Allergy to any of the study drugs elicited from history.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andrew Kintu, M.med
    Organizational Affiliation
    Department of Anesthesia and Critical Care, Makerere University, College of Health Sciences, Kampala,Uganda
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Timothy Muyimbo, M.med
    Organizational Affiliation
    Department of Anesthesia and Critical Care, Makerere University, College of Health Sciences, Kampala,Uganda
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Fred Bulamba, M.med
    Organizational Affiliation
    Department of Anesthesia and Critical Care, Makerere University, College of Health Sciences, Kampala,Uganda
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16878530
    Citation
    Decosterd I, Beggah AT, Durrer A, Buchser E. [Spinal opioids: mechanisms of action and chronic pain management]. Rev Med Suisse. 2006 Jun 21;2(71):1636-8, 1640. French.
    Results Reference
    result
    PubMed Identifier
    9187779
    Citation
    Cascio M, Pygon B, Bernett C, Ramanathan S. Labour analgesia with intrathecal fentanyl decreases maternal stress. Can J Anaesth. 1997 Jun;44(6):605-9. doi: 10.1007/BF03015443.
    Results Reference
    result
    PubMed Identifier
    12160502
    Citation
    Fontaine P, Adam P, Svendsen KH. Should intrathecal narcotics be used as a sole labor analgesic? A prospective comparison of spinal opioids and epidural bupivacaine. J Fam Pract. 2002 Jul;51(7):630-5.
    Results Reference
    result

    Learn more about this trial

    Labour Analgesia; Comparing a Combinations of Either Fentanyl or Bupivacaine With Intrathecal Morphine

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