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

Sponsor

Makerere University (Other)

Overall Status

Completed

CT.gov ID

NCT02498171

Collaborator

(none)

138

Enrollment

Arms

1.9

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Labor Pain	Drug: Intrathecal morphine with fentanyl Drug: Intrathecal morphine with bupivacaine	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

138 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

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 Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

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

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

Other Names:

Morphine Sulphate 10mg/ml, Ampoule 1ml, Martindale Hong Kong

sesorcaine 0.5%, Ampoule 4ml, Astrazeneca

Outcome Measures

Primary Outcome Measures

Duration of analgesia [10 hours]
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 [6 minutes]
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) [34 hours]
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.

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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