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

Makerere University138 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

138

Conditions

Labor Pain

Interventions

Intrathecal morphine with fentanylDRUG

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

Intrathecal morphine with bupivacaineDRUG

Eligibility

Sex: FEMALEMin age: 14 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 10 hours

Secondary Outcomes

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).

Time frame: 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.

Time frame: 34 hours

Data from ClinicalTrials.gov

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