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

Not Applicable

Completed

• Conditions: Labor Pain
• Interventions: Drug: Intrathecal morphine with fentanyl; Drug: Intrathecal morphine with bupivacaine

• Registration Number: NCT02498171
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2015-07
• Study First Submitted: 2015-07-07
• Study First Submitted QC: 2015-07-12
• Last Update Submitted: 2015-07-12
• Study First Posted: 2015-07-15
• Last Update Posted: 2015-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 138

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intrathecal morphine with fentanyl	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.
Intrathecal morphine with bupivacaine	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.

Primary Outcome Measures

Name	Time	Method
Duration of analgesia	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

Name	Time	Method
APGAR score	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).
Maternal side effects (composite)	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.