Labor Pain
Conditions
Keywords
Labour analgesia, Intrathecal morphine, Bupivacaine, Fentanyl
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.
Interventions
DRUGIntrathecal 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
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
Sponsors
Makerere University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed