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

Condition(s) targeted: Labor Pain

Intervention: Intrathecal morphine with fentanyl (Drug); Intrathecal morphine with bupivacaine (Drug)

Phase: N/A

Status: Completed

Sponsored by: Makerere University

Official(s) and/or principal investigator(s):
Andrew Kintu, M.med, Study Director, Affiliation: Department of Anesthesia and Critical Care, Makerere University, College of Health Sciences, Kampala,Uganda
Timothy Muyimbo, M.med, Principal Investigator, Affiliation: Department of Anesthesia and Critical Care, Makerere University, College of Health Sciences, Kampala,Uganda
Fred Bulamba, M.med, Study Chair, Affiliation: Department of Anesthesia and Critical Care, Makerere University, College of Health Sciences, Kampala,Uganda

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: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: Duration of analgesia

Secondary outcome:

APGAR score

Maternal side effects (composite)

Minimum age: 14 Years. Maximum age: 60 Years. Gender(s): Female.

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.

Starting date: January 2014
Last updated: July 12, 2015