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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Labor Pain

Intervention / Treatment
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* Drug: Intrathecal morphine with fentanyl
* Drug: Intrathecal morphine with bupivacaine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intrathecal morphine with fentanyl<br>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<br>* 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<br>* Other names: Fentanyl Citrate 0.05mg/ml, Ampoule 2ml,Martindale Hong Kong;|
| Active Comparator: Intrathecal morphine with bupivacaine<br>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<br>* 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<br>* Other names: sesorcaine 0.5%, Ampoule 4ml, Astrazeneca;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 10 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 6 minutes | 
| 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. | 34 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Labour analgesia, Intrathecal morphine, Bupivacaine, Fentanyl