CSE for Labour Analgesia: A Comparison of Two Intrathecal Regimens

Study Overview
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Brief Summary
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Analgesia in labour is not readily available in many parts of Sub-Saharan Africa. The overall cost of Epidural services in terms of human personnel and financial implication makes this inaccessible to many women in labour. Thus, a cheaper, less technically demanding and easier option that can produce as much satisfaction for the parturient and would allow her participate in the second stage of labour by being able to bare down is being studied. The Single Shot Spinal (SSS) would provide pain relief in these women however its draw back is its time limitation as the option of a top up is not available. Two regimen of drug options would be considered using opioids. These would be compared to see how well they are able to provide analgesia in women who hitherto have had vaginal birth. Their onset, duration of action and possible side effects would be compared. NULL HYPOTHESIS: Single Shot Spinal with Bupivacaine Fentanyl (BF) cannot provide a statistically significant difference in labour analgesia in comparison with Bupivacaine Fentanyl Morphine (BFM) ALTERNATE HYPOTHESIS: Single Shot Spinal with BF can provide a statistically significant difference in labour in comparison with BFM

Detailed Description
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A double blinded randomized study comparing 2 intrathecal mixtures for labour analgesia. 94 multiparous parturients in active labour who have given informed consent would be recruited into the study. They would be randomly allocated into 2 groups using simple random sampling. An Assistant would know the code and prepare the intrathecal solutions. Baseline vitals would be taken and patient's pain score noted. Due protocol would be followed and a combined spinal epidural sited but with the epidural not activated until the effect of the spinal wears off. Routine monitoring would be done and various parameters and indices noted. Where the effect of the spinal lasts the duration of labour thus no need to activate the epidural, this would also be noted. Data would be analysed using Statistical Package of Social Sciences (SPSS) version 20.

Official Title
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Combined Spinal Epidural Analgesia in Labour: A Comparison of Two Intrathecal Regimens of Single Shot Spinal

Conditions
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Labor Pain

Intervention / Treatment
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* Drug: Bupivacaine-fentanyl
* Drug: Bupivacaine-fentanyl morphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parturients in active labour >4cm dilatation American Society of Anesthesiologists (ASA) classification I and II Exclusion Criteria: Significant co-morbidities like uncontrolled hypertension or diabetes Maternal hemorrhage with hypotension Significant bleeding/clotting disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 groups that would remain with the randomly picked intervention throughout the study duration
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BF<br>Interventions: Intrathecal administration -Bupivacaine 2.5mg (0.5ml) + Fentanyl 25mcg (0.5ml) + 1ml sterile water in one shot Ephedrine 3-5mg in aliquots in the event of hypotension Promethazine 12.5 - 25mg in the event of vomiting or significant pruritus naloxone 2mcg/kg in the event of respiratory distress | Drug: Bupivacaine-fentanyl<br>* Dosages as previously written<br>|
| Active Comparator: BFM<br>Interventions: Intrathecal administration - Bupivacaine 2.5mg (0.5ml) + fentanyl 25mcg (0.5ml) + 0.25mg morphine (0.25ml) + 0.75ml sterile water in one shot ephedrine 3-5mg in aliquots for hypotension Promethazine 12.5 - 25mg for vomiting or significant pruritus Naloxone 2mcg/kg in the event of respiratory distress | Drug: Bupivacaine-fentanyl morphine<br>* Dosage as previously written<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First painless contraction (TFC) | This is the onset of action of the drugs. The time duration from the initiation of the block at time zero to the point where there is significant drop in the Numerical Rating Scale (NRS) to 2 or less | time zero to first painless contraction estimated 15 minutes | 
| Time to First Request for Analgesia (TFA) | This is the duration of action of the block. Time from initiation of the block to time the pain score is up to 6 or more. It is expected that after onset of the block (TFC) the pain would first become negligible or absent and after a period of time, it would gradually increase as the drug wears off. If the pain becomes moderate at a NRS of 6 or the patient requests for analgesia, the time would be noted and the epidural would be activated. | Time zero till NRS > 6 estimated 180 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delivery before TFA or delivery after TFA | Qualitative variable. determines if rescue analgesia was needed (if the epidural needed to be activated) or if the spinal was adequate for the duration of labour | duration of labour estimated 180 minutes | 
| Maternal Satisfaction | Parturients perception of if analgesia was Adequate, Inadequate or Not Sure | up to 300 minutes | 
| Side effects | Presence of side effects like respiratory depression, pruritus, or vomiting | up to 180 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Single Shot Spinal, Intrathecal narcotics, Morphine, Fentanyl, Labour Analgesia