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
Overview
- Phase
- Not Applicable
- Intervention
- Intrathecal morphine with fentanyl
- Conditions
- Labor Pain
- Sponsor
- Makerere University
- Enrollment
- 138
- Primary Endpoint
- Duration of analgesia
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
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.
Arms & Interventions
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.
Intervention: Intrathecal morphine with fentanyl
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.
Intervention: Intrathecal morphine with bupivacaine
Outcomes
Primary Outcomes
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
- APGAR score(6 minutes)
- Maternal side effects (composite)(34 hours)