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

Labor Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02498171
• Other study ID #: 2011/HD07/2061U
• Status: Completed
• Phase: N/A
• First received: July 7, 2015
• Last updated: July 12, 2015
• Start date: January 2014
• Est. completion date: March 2014

Study information

• Verified date: July 2015
• Source: Makerere University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: National Council for Science and TechnologyUganda: National Drug Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Labor Pain

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Makerere University

References & Publications (3)

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. — View 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. Review. French. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	Time of onset of analgesia	Parturients would be monitored for when relief from pain was first felt.	After drug administartion	No
Primary	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	No
Secondary	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	Yes
Secondary	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	Yes