Clinical trial NCT02498171: Labour Analgesia; Comparing a Combinations of Either Fentanyl or Bupivacaine With Intrathecal Morphine
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Keywords: Labour analgesia
Intrathecal morphine
Bupivacaine
Fentanyl
Lead sponsor: Makerere University
Sponsor class: OTHER
First posted: 2015-07-15
Enrollment: 138
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Duration of analgesia
timeFrame: 10 hours
Secondary outcomes:
measure: APGAR score
timeFrame: 6 minutes
measure: Maternal side effects (composite)
timeFrame: 34 hours
Other outcomes:
measure: Degree of satisfaction
timeFrame: 24 hours after delivery
measure: Time of onset of analgesia
timeFrame: After drug administartion
Locations:
Study officials:
affiliation: Department of Anesthesia and Critical Care, Makerere University, College of Health Sciences, Kampala,Uganda
name: Andrew Kintu, M.med
role: STUDY_DIRECTOR
affiliation: Department of Anesthesia and Critical Care, Makerere University, College of Health Sciences, Kampala,Uganda
name: Timothy Muyimbo, M.med
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesia and Critical Care, Makerere University, College of Health Sciences, Kampala,Uganda
name: Fred Bulamba, M.med
role: STUDY_CHAIR
References:
citation: Decosterd I, Beggah AT, Durrer A, Buchser E. [Spinal opioids: mechanisms of action and chronic pain management]. Rev Med Suisse. 2006 Jun 21;2(71):1636-8, 1640. French.
citation: Cascio M, Pygon B, Bernett C, Ramanathan S. Labour analgesia with intrathecal fentanyl decreases maternal stress. Can J Anaesth. 1997 Jun;44(6):605-9. doi: 10.1007/BF03015443.
citation: Fontaine P, Adam P, Svendsen KH. Should intrathecal narcotics be used as a sole labor analgesic? A prospective comparison of spinal opioids and epidural bupivacaine. J Fam Pract. 2002 Jul;51(7):630-5.