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

Makerere University

Status: Completed

Conditions: Labor Pain

Treatments: Drug: Intrathecal morphine with bupivacaine; Drug: Intrathecal morphine with fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT02498171

2011/HD07/2061U

Details and patient eligibility

About

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.

Enrollment: 138 patients

Sex: Female

Ages: 14 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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138 participants in 2 patient groups

Intrathecal morphine with fentanyl

Experimental group

Description:

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.

Treatment:

Drug: Intrathecal morphine with fentanyl

Intrathecal morphine with bupivacaine

Active Comparator group

Description:

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.

Treatment:

Drug: Intrathecal morphine with bupivacaine