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

NCT02498171 | Completed DMC

• 1 other identifier: 2011/HD07/2061U
• Study Type: interventional
• Target: 138
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Labor Pain

Keywords

Labour analgesia; Intrathecal morphine; Bupivacaine; Fentanyl

Outcome Measures

Primary Outcomes (1)

• 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

  10 hours

Secondary Outcomes (2)

• APGAR score

  6 minutes

• Maternal side effects (composite)

  34 hours

Other Outcomes (2)

• Degree of satisfaction

  24 hours after delivery

• Time of onset of analgesia

  After drug administartion

Study Arms (2)

Intrathecal morphine with fentanyl

EXPERIMENTAL

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.

Drug: Intrathecal morphine with fentanyl

Intrathecal morphine with bupivacaine

ACTIVE COMPARATOR

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.

Drug: Intrathecal morphine with bupivacaine

Interventions

Intrathecal morphine with fentanyl DRUG

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

Also known as: Morphine Sulphate 10mg/ml, Ampoule 1ml,Martindale Hong Kong, Fentanyl Citrate 0.05mg/ml, Ampoule 2ml,Martindale Hong Kong

Intrathecal morphine with fentanyl

Intrathecal morphine with bupivacaine DRUG

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

Also known as: Morphine Sulphate 10mg/ml, Ampoule 1ml, Martindale Hong Kong, sesorcaine 0.5%, Ampoule 4ml, Astrazeneca

Intrathecal morphine with bupivacaine

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Parturients with singleton pregnancy
• Emancipated minors

You may not qualify if:

• 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.

Sponsors & Collaborators

• Makerere University: lead

Related Publications (3)

• 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.

  PMID: 16878530 RESULT

• 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.

  PMID: 9187779 RESULT

• 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.

  PMID: 12160502 RESULT

MeSH Terms

Conditions

Labor Pain

Interventions

Fentanyl; Morphine; Bupivacaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Andrew Kintu, M.med

  Department of Anesthesia and Critical Care, Makerere University, College of Health Sciences, Kampala,Uganda

  STUDY DIRECTOR

• Timothy Muyimbo, M.med

  Department of Anesthesia and Critical Care, Makerere University, College of Health Sciences, Kampala,Uganda

  PRINCIPAL INVESTIGATOR

• Fred Bulamba, M.med

  Department of Anesthesia and Critical Care, Makerere University, College of Health Sciences, Kampala,Uganda

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2015
• First Posted: July 15, 2015
• Study Start: January 1, 2014
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: July 15, 2015

Record last verified: 2015-07