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

NCT ID: NCT02498171

Last Updated: 2015-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Intrathecal morphine with fentanyl

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Intrathecal morphine with bupivacaine

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Morphine Sulphate 10mg/ml, Ampoule 1ml,Martindale Hong Kong; Fentanyl Citrate 0.05mg/ml, Ampoule 2ml,Martindale Hong Kong; Morphine Sulphate 10mg/ml, Ampoule 1ml, Martindale Hong Kong; sesorcaine 0.5%, Ampoule 4ml, Astrazeneca

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Makerere University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Kintu, M.med

Role: STUDY_DIRECTOR

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

Timothy Muyimbo, M.med

Role: PRINCIPAL_INVESTIGATOR

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

Fred Bulamba, M.med

Role: STUDY_CHAIR

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

References

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.

Reference Type: RESULT

PMID: 16878530 (View on PubMed)

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.

Reference Type: RESULT

PMID: 9187779 (View on PubMed)

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.

Reference Type: RESULT

PMID: 12160502 (View on PubMed)

Other Identifiers

2011/HD07/2061U

Identifier Type: -

Identifier Source: org_study_id