Dural Puncture Epidural Versus Combined Spinal Epidural With Epidural Volume Extension in Labor Analgesia

Study Overview
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Brief Summary
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Labor is the process where the cervix is prepared to allow the baby to pass from the uterine cavity to the outside world. In the ordinary course, it ends with spontaneous or instrumental vaginal delivery or cesarean section. Traditionally, the first stage in which the cervix is passively dilated in response to uterine contractions consists of the second stage in which the mother passes the baby through the vagina and the third stage, the exit of the placenta. In the first stage of labor, pain is caused by uterine contractions and pressure on the cervix. Pain is transmitted through the T10-L2 spinal nerves and is felt in the abdominal wall, waist, hips, or thighs. In the second stage, pain from the vagina and perineum is added to uterine pain. This pain is transmitted by the pudendal nerves through the S2-4 nerve roots. In this study, we aimed to investigate the effects of dural puncture epidural analgesia versus combined spinal-epidural analgesia with epidural volume extension on labor variables.

Official Title
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The Effects of Dural Puncture Epidural Versus Combined Spinal Epidural With Epidural Volume Extension Techniques on Birth Variables in Labor Analgesia

Conditions
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Labor Pain

Intervention / Treatment
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* Drug: Epidural
* Drug: Intrathecal+Epidural


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I and II parturients Pregnant patients in active labor active labor with cervical dilation < 5cm 37-42 weeks of gestational age Pregnant women between the ages of 18 and 45 Exclusion Criteria: Patients who do not want to participate voluntarily in the study Pregnant women outside the age range of 18 - 45 Pregnants other than Nullipar Patients with allergic reactions to anesthesia and analgesia drugs to be used Severe systemic disease (kidney, liver, pulmonary, endocrine, cardiac) Gestational comorbidity (preeclampsia, eclampsia, diabetes mellitus, etc.) Substance abuse history Chronic pain history Psychiatric problems and communication difficulties BMI> 35 kg / m2 Failure in neuraxial interventions

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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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dural puncture epidural<br>2 µg/ml fentanyl + %0,125 bupivacaine (20 ml) to epidural | Drug: Epidural<br>* 2 µg/ml fentanyl + %0,125 bupivacaine (20 ml) to epidural<br>|
| Active Comparator: Combined spinal-epidural with epidural volume extension<br>10 µg fentanyl + 2 mg bupivacaine to intrathecal 7.4 ml saline volume to epidural | Drug: Intrathecal+Epidural<br>* 10 µg fentanyl + 2 mg bupivacaine to intrathecal 7.4 ml saline volume to epidural<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First Epidural top-up time | Time elapsed between the end of local anesthetic injection and the return of pain >4 on the NPRS. | First 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sacral analgesia time | Blockade of the S2 dermatome | First 24 hours | 
| Performance time | interval between skin disinfection and epidural catheter fixation to the skin | First 24 hours | 
| Incidence of Side Effect | maternal motor block, hypotension, pruritis, headache and fetal bradycardia | First 24 hours |