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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02498171
Recruitment Status : Completed
First Posted : July 15, 2015
Last Update Posted : July 15, 2015
Sponsor:
Information provided by (Responsible Party):
Makerere University

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.


Condition or disease Intervention/treatment Phase
Labor Pain Drug: Intrathecal morphine with fentanyl Drug: Intrathecal morphine with bupivacaine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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 Start Date : January 2014
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intrathecal morphine with fentanyl
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.
Drug: Intrathecal morphine with fentanyl

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

Other Names:
  • Morphine Sulphate 10mg/ml, Ampoule 1ml,Martindale Hong Kong
  • Fentanyl Citrate 0.05mg/ml, Ampoule 2ml,Martindale Hong Kong

Active Comparator: Intrathecal morphine with bupivacaine
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.
Drug: Intrathecal morphine with bupivacaine

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

Other Names:
  • Morphine Sulphate 10mg/ml, Ampoule 1ml, Martindale Hong Kong
  • sesorcaine 0.5%, Ampoule 4ml, Astrazeneca




Primary Outcome Measures :
  1. Duration of analgesia [ Time Frame: 10 hours ]
    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 :
  1. APGAR score [ Time Frame: 6 minutes ]
    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).

  2. Maternal side effects (composite) [ Time Frame: 34 hours ]
    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.


Other Outcome Measures:
  1. Degree of satisfaction [ Time Frame: 24 hours after delivery ]
    Mothers would be asked if they were satisfied with their pain control during labor and if they would recommend to others

  2. Time of onset of analgesia [ Time Frame: After drug administartion ]
    Parturients would be monitored for when relief from pain was first felt.



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Ages Eligible for Study:   14 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02498171


Sponsors and Collaborators
Makerere University
Investigators
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Study Director: Andrew Kintu, M.med Department of Anesthesia and Critical Care, Makerere University, College of Health Sciences, Kampala,Uganda
Principal Investigator: Timothy Muyimbo, M.med Department of Anesthesia and Critical Care, Makerere University, College of Health Sciences, Kampala,Uganda
Study Chair: Fred Bulamba, M.med Department of Anesthesia and Critical Care, Makerere University, College of Health Sciences, Kampala,Uganda
Publications of Results:
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Responsible Party: Makerere University
ClinicalTrials.gov Identifier: NCT02498171    
Other Study ID Numbers: 2011/HD07/2061U
First Posted: July 15, 2015    Key Record Dates
Last Update Posted: July 15, 2015
Last Verified: July 2015
Keywords provided by Makerere University:
Labour analgesia
Intrathecal morphine
Bupivacaine
Fentanyl
Additional relevant MeSH terms:
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Labor Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Fentanyl
Morphine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General