Epidural Analgesia, Labor Pain
Conditions
Keywords
Labor Analgesia, Epidural Analgesia, Dural Puncture Epidural
Brief summary
Childbirth is an intense physical and psychological experience. Epidural analgesia (EP) remains the gold standard in labor pain management. However, continuous refinements are aimed at enhancing analgesic quality and mitigating adverse effects. In recent years, the dural puncture epidural (DPE) technique has gained popularity. In this technique, the dura is intentionally punctured with a spinal needle before the epidural catheter is placed, but no intrathecal medication is administered. This historically controlled study evaluates the clinical outcomes of a protocol transition from standard high-dose epidural to low-dose DPE. The primary objective is to compare total analgesic consumption and success rates of labor analgesia between the two techniques. The secondary objectives include the assessment of hemodynamic parameters, motor block characteristics, adverse effects (such as paresthesia and hypotension), and overall maternal satisfaction
Detailed description
The maternal pain experience encompasses psychological and emotional components, highlighting the necessity for patient-centered assessment approaches. While standard epidural and combined spinal-epidural (CSE) techniques are common, they carry risks such as inadequate sacral coverage, motor block, or fetal bradycardia. The dural puncture epidural (DPE) technique aims to combine the advantages of EP and CSE while minimizing their disadvantages. By creating a dural hole, DPE facilitates the translocation of epidural medications into the subarachnoid space, aiming to accelerate the onset of analgesia and improve block quality.This single-center, historically controlled study consists of two consecutive cohorts managed before and after a change in the clinical protocol. Group 1 (retrospective control) received standard concentration epidural analgesia. Group 2 (prospective intervention) received the low-dose DPE technique. The study hypothesizes that the low-dose DPE technique provides non-inferior analgesic efficacy with significantly reduced total bupivacaine consumption and a superior side-effect profile compared to the standard high-dose EP technique. Outcomes evaluated include total bupivacaine consumption, adequate analgesia success (NRS \< 4), maternal hemodynamic changes, incidence of adverse effects including paresthesia, and patient satisfaction. Note on outcome reporting: serial intrapartum measurements of maternal blood pressure, maternal heart rate and fetal heart rate were not documented on the routine anesthesia monitoring forms used during the retrospective control period. The registered secondary outcome of maternal hemodynamic and fetal heart rate variation could therefore not be compared between the two cohorts. Baseline values recorded before the procedure were available for all 100 participants and are reported as baseline characteristics, together with the incidence of hypotension and of fetal bradycardia. No registered outcome has been removed from this record.
Interventions
PROCEDUREStandard Epidural Analgesia
Administration of conventional epidural analgesia using an 18G Tuohy needle for catheter placement and subsequent administration of a standardized dose of bupivacaine with fentanyl.
PROCEDUREDural Puncture Epidural Analgesia
Administration of epidural analgesia that incorporates a dural puncture with a 27G spinal needle prior to epidural catheter placement, followed by administration of a lower concentration of bupivacaine with the same dose of fentanyl.
Sponsors
Medipol University
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists (ASA) physical status I-II * Gestational age 37-42 weeks * Planned vaginal delivery * Request for labor analgesia during active labor with cervical dilation ≥ 4 cm
Exclusion criteria
* Multiple gestations * Diagnosis of preeclampsia/eclampsia * Severe systemic disease * Contraindications to epidural analgesia (e.g., coagulopathy, infection at the injection site) * History of opioid dependence * Refusal to participate in the study protocol * Missing data in medical records for the retrospective group
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adequate Analgesia Achievement | Assessed at 15 minutes post-procedure and during hourly follow-ups until delivery. | Proportion of participants achieving a target Numeric Rating Scale (NRS) score of less than 4 |
| Total Analgesic Consumption | From the initiation of epidural analgesia until delivery. | Cumulative bupivacaine consumption measured in milligrams. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Requirement for Supplemental Analgesia | From the initiation of epidural analgesia until delivery. | Total number of supplemental boluses required during labor |
| Maternal Satisfaction | Assessed in the early postpartum period. | Documented patient satisfaction levels regarding the childbirth experience |
| Post-Dural Puncture Headache | Up to 1 week postpartum. | Incidence and severity of post-dural puncture headache in the postpartum period. |
| Incidence and Severity of Motor Block | Monitored throughout the procedure until delivery. | Occurrence and degree of motor block, evaluated by the Modified Bromage Scale. |
| Maternal Hemodynamic and Fetal Heart Rate Variations | Continuously monitored throughout the procedure. | Variation in maternal blood pressure, heart rate, and fetal heart rate changes. |
| Incidence of Adverse Effects | Continuously monitored from the initial epidural dose until delivery. | Recording of adverse effects including nausea, vomiting, pruritus, hypotension, and paresthesia |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORBurak öMÜR
Medipol University
Outcome results
None listed