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

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

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 Overview

• Status: Completed
• Conditions: Labor Pain
• Intervention / Treatment: Drug: Intrathecal morphine with fentanyl; Drug: Intrathecal morphine with bupivacaine

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intrathecal morphine with fentanyl; 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; 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; Other Names: Morphine Sulphate 10mg/ml, Ampoule 1ml,Martindale Hong Kong; Fentanyl Citrate 0.05mg/ml, Ampoule 2ml,Martindale Hong Kong
Active Comparator: Intrathecal morphine with bupivacaine; 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; 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; Other Names: Morphine Sulphate 10mg/ml, Ampoule 1ml, Martindale Hong Kong; sesorcaine 0.5%, Ampoule 4ml, Astrazeneca

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	34 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of satisfaction	Mothers would be asked if they were satisfied with their pain control during labor and if they would recommend to others	24 hours after delivery
Time of onset of analgesia	Parturients would be monitored for when relief from pain was first felt.	After drug administartion

Collaborators and Investigators

• Sponsor: Makerere University
• Investigators: Study Director: Andrew Kintu, M.med, Department of Anesthesia and Critical Care, Makerere University, College of Health Sciences, Kampala,Uganda; Principal Investigator: Timothy Muyimbo, M.med, Department of Anesthesia and Critical Care, Makerere University, College of Health Sciences, Kampala,Uganda; Study Chair: Fred Bulamba, M.med, Department of Anesthesia and Critical Care, Makerere University, College of Health Sciences, Kampala,Uganda

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: July 7, 2015
• First Submitted That Met QC Criteria: July 12, 2015
• First Posted (Estimate): July 15, 2015

Study Record Updates

• Last Update Posted (Estimate): July 15, 2015
• Last Update Submitted That Met QC Criteria: July 12, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Fentanyl; Bupivacaine; Labour analgesia; Intrathecal morphine
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Bupivacaine; Morphine
• Other Study ID Numbers: 2011/HD07/2061U

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No