Onset of Labour Epidural Analgesia With Different Concentration Bupivacaine and Different Doses of Sufentanyl

Study Overview
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Brief Summary
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This study aimed to compare the effects of three commonly used combination doses on the onset time and adverse reactions.

Detailed Description
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Epidural block is widely used as an analgesic method during labor. During epidural anaesthesia, lipophilic opioids such as sufentanil, are often combined with local anesthetics to prolong the duration of analgesia and improve the analgesic effect. However, dose combinations of local anesthetics and opioids, especially in the initial loading dose, vary greatly from hospital to hospital and often depend upon the different routines adopted by anesthesiologists. In clinical practice, there are still some controversy about opioid dose selection in terms of analgesic onset time and adverse reactions. In this study, three combinations of bupivacaine and sufentanil were chosen, commonly used in the clinic, and extended the observation period to 24 hours after delivery. We hypothesized that increasing the concentration of local anesthetic, rather than increasing the dose of sufentanil, would achieve a faster analgesic effect with minimal adverse effects on the mother and fetus. To test our hypothesis, our primary outcome was to compare the times of analgesia onset of the three combinations, and the secondary outcomes were to compare the effects on maternal and infant adverse reactions.

Official Title
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A Randomized Controlled Comparison of Different Dose Combinations of Bupivacaine and Sufentanil on Epidural Analgesia Onset Time and Adverse Reactions During Labor

Conditions
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Pregnant Women Who Requested Epidural Analgesia in the Early Stage of Labor

Intervention / Treatment
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* Drug: B1S5
* Drug: B125S5
* Drug: B1S10


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:patients ASA physical status 1 or 2; early labour (cervical dilation 5 cm or less); singleton fetus; gestational age > 36 weeks; and normal fetal heart rate (FHR) tracing. - Exclusion Criteria:severe preeclampsia;antepartum haemorrhage; ASA 3 or more; chronic pain; substance abuse;contraindications to epidural analgesia; allergies to local anaesthetics or fentanyl; body mass index (BMI) over 40; and previous administration of opioid analgesia within 24 h. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 0.1%bupivacaine+10µg sufentanyl<br>Epidural labour analgesia was initiated with 10µg sufentanyl along with 5 ml bupivacaine 0.1% as the test dose. After 3 min, 10 ml of 0.1% bupivacaine epidural was injected | Drug: B1S10<br>* Women were then placed supine with left uterine displacement. Epidural labour analgesia was initiated with 10µg sufentanyl along with 5 ml bupivacaine 0.1% as the test dose. After 3 min, 10 ml of 0.1% bupivacaine epidural was injected<br>|
| Active Comparator: 0.125%bupivacaine+5µg sufentanyl<br>Epidural labour analgesia was initiated with 5µg sufentanyl along with 5 ml bupivacaine 0.125% as the test dose. After 3 min, 10 ml of 0.125% bupivacaine epidural was injected | Drug: B125S5<br>* Women were then placed supine with left uterine displacement. Epidural labour analgesia was initiated with 5µg sufentanyl along with 5 ml bupivacaine 0.125% as the test dose. After 3 min, 10 ml of 0.125% bupivacaine epidural was injected<br>|
| Active Comparator: 0.1%bupivacaine+5µg sufentanyl<br>Epidural labour analgesia was initiated with 5µg sufentanyl along with 5 ml bupivacaine 0.1% as the test dose. After 3 min, 10 ml of 0.1% bupivacaine epidural was injected | Drug: B1S5<br>* Women were then placed supine with left uterine displacement. Epidural labour analgesia was initiated with 5µg sufentanyl along with 5 ml bupivacaine 0.1% as the test dose. After 3 min, 10 ml of 0.1% bupivacaine epidural was injected<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the time to achieve effective analgesia | We defined the onset of analgesia as the time from the start of the injection to the time when the NPRS score was reduced to at least half of the original score. | 30 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensory block, maternal side effects (pruritus, hypotension, sedation，motor block and decreased fetal heart rate) were recorded at 5-min intervals for 30 min. sedation) |  | 30min | 
| time from the first PCA bolus, patient satisfaction, type of delivery, fever, establishment of breast feeding and LATCH score within 24 h, cumulative dosage of sufentanil/bupivacaine, time from bolus to delivery. |  | delivery 24h |