Comparison of Levobupivacaine-Fentanyl for labor analgesia via dural puncture epidural and lumbar epidural techniques

**Title :**Comparison of levobupivacaine-fentanyl for labor analgesia via dural puncture epidural technique and lumbar epidural technique

**Rationale:**Levobupivacaine-fentanyl is a commonly used combination for labor analgesia via neuraxial route. It can be given both intrathecally and epidurally in appropriate formulations. It has a motor sparing effect and hence is suitable for walking epidural analgesia. Dural puncture epidural (DPE) is a relatively new and safe technique of neuraxial block. Local anesthetics which have a slower trans-meningeal transfer are the ones which may be more suitable for this technique of neuraxial anesthesia. This study is planned to explore the suitability of levobupivacaine-fentanyl for DPE.

**Aim:**To determine and compare the suitability of levobupivacaine-fentanyl for labor analgesia via dural puncture epidural and lumbar epidural techniques

Objectives:

To determine and compare the suitability of levobupivacaine-fentanyl for labor analgesia via DPE and lumbar epidural (LE) techniques in terms of

Primary objective : Block onset time

Secondary objectives:

1.     percentage of patients having effective block in the first 10 min,

2.     sensory block level and motor block intensity,

3.     occurrence of maternal side effects related to neuraxial procedure,

4.     Ancillary observations like type of delivery, neonatal outcomes, patient satisfaction etc.

Methods: This prospective, randomised double blind study will be done after approval from the institutional ethics committee between April 2024 to August 2025. Consenting, healthy, adult nulliparous females with singleton pregnancy with vertex presentation, gestational age >37 weeks, height >150cm, <180cm, cervical dilation 2 to 5cm, VAS score>5cm, admitted in labor room will be included. Participants will be randomly allocated to either DPE group or conventional epidural group. After a negative test dose, 12 ml of levobupivacaine (0.1%) with fentanyl (50µg) will be injected epidurally over two minutes to initiate labor analgesia. Further analgesia will be provided using programmed intermittent epidural boluses consisting of 10 ml levobupivacaine (0.1%) and fentanyl (2 µg/ml). Pain scores, maternal hemodynamic parameters (BP and HR), sensory and motor block characteristics will be assessed every 2 mins until 20 mins, 60 min after the loading dose and then at 1hour intervals until the patient’s cervix is fully dilated.

**Sample size:**There is no study which has given the time of onset of levobupivacaine-fentanyl combination in DPE. Taking reference from a previous study which has used ropivacaine-fentanyl where the time of onset was 12 (10-16) min in epidural group and 10 (6-12) min in dural puncture epidural group, to estimate a difference of atleast 1 min at alpha =5% and power=80%, a sample of 48 subjects is required in each group.

Statistical Analysis: Data will be entered in a spreadsheet and will be analysed using SPSS v. 20.0. Continuous variables will be expressed as mean ± SD or median [IQR]. Categorical data will be expressed as number (percentage). Qualitative parameters will be compared by Chi-square test/Fischer’s exact test and quantitative parameters by unpaired T tests. Repeatedly measured quantitative parameters will be compared by repeat measures ANOVA followed by Tukey’s test.  A p-value <0.05 will be taken as significant.