Labour Analgesia; Comparing a Combinations of Either Fentanyl or Bupivacaine With Intrathecal Morphine
Primary Purpose
Labor Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intrathecal morphine with fentanyl
Intrathecal morphine with bupivacaine
Sponsored by
About this trial
This is an interventional prevention trial for Labor Pain focused on measuring Labour analgesia, Intrathecal morphine, Bupivacaine, Fentanyl
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intrathecal morphine with fentanyl
Intrathecal morphine with bupivacaine
Arm 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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02498171
Brief Title
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
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Makerere University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
Labour analgesia, Intrathecal morphine, Bupivacaine, Fentanyl
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
138 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intrathecal morphine with fentanyl
Arm Type
Experimental
Arm 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.
Arm Title
Intrathecal morphine with bupivacaine
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Intrathecal morphine with fentanyl
Other Intervention Name(s)
Morphine Sulphate 10mg/ml, Ampoule 1ml,Martindale Hong Kong, Fentanyl Citrate 0.05mg/ml, Ampoule 2ml,Martindale Hong Kong
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Intrathecal morphine with bupivacaine
Other Intervention Name(s)
Morphine Sulphate 10mg/ml, Ampoule 1ml, Martindale Hong Kong, sesorcaine 0.5%, Ampoule 4ml, Astrazeneca
Intervention Description
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
Primary Outcome Measure Information:
Title
Duration of analgesia
Description
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
Time Frame
10 hours
Secondary Outcome Measure Information:
Title
APGAR score
Description
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).
Time Frame
6 minutes
Title
Maternal side effects (composite)
Description
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.
Time Frame
34 hours
Other Pre-specified Outcome Measures:
Title
Degree of satisfaction
Description
Mothers would be asked if they were satisfied with their pain control during labor and if they would recommend to others
Time Frame
24 hours after delivery
Title
Time of onset of analgesia
Description
Parturients would be monitored for when relief from pain was first felt.
Time Frame
After drug administartion
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Kintu, M.med
Organizational Affiliation
Department of Anesthesia and Critical Care, Makerere University, College of Health Sciences, Kampala,Uganda
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Timothy Muyimbo, M.med
Organizational Affiliation
Department of Anesthesia and Critical Care, Makerere University, College of Health Sciences, Kampala,Uganda
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fred Bulamba, M.med
Organizational Affiliation
Department of Anesthesia and Critical Care, Makerere University, College of Health Sciences, Kampala,Uganda
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
16878530
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.
Results Reference
result
PubMed Identifier
9187779
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.
Results Reference
result
PubMed Identifier
12160502
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.
Results Reference
result
Learn more about this trial
Labour Analgesia; Comparing a Combinations of Either Fentanyl or Bupivacaine With Intrathecal Morphine
We'll reach out to this number within 24 hrs