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NCT Number: NCT02498171

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

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.

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Key information

Conditions

Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

14 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intrathecal morphine with fentanyl

Drug

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

Intrathecal morphine with bupivacaine

Drug

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 outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Makerere University

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 15, 2015
Registry last updated
Jul 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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