Does Body Mass Index Impact the Outcome of Dural Puncture Epidural in Parturients Undergoing Normal Vaginal Delivery

Study Overview
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Brief Summary
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Recently, the dural puncture epidural (DPE) technique has emerged as a novel method of labor analgesia. The DPE technique is a modification of the combined spinal epidural (CSE) technique, where a dural perforation is created from a spinal needle but intrathecal medication administration is withheld. The DPE technique has been shown to improve caudal spread of analgesia compared with epidural technique without the side effects observed with the CSE technique.

Detailed Description
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Investigators designed this prospective interventional study to determine if morbid obesity would influence DPE technique regarding labor analgesia onset and block characteristics.

Official Title
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Does Body Mass Index Impact the Outcome of Dural Puncture Epidural in Parturients Undergoing Normal Vaginal Delivery

Conditions
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Morbid Obesity

Intervention / Treatment
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* Other: Dural puncture epidural


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 - 45 years old, Physical status American society of anesthesiology (ASA) II, Singleton, Vertex fetuses at 37-41 weeks' gestation, Nulliparous and multiparous women, Immediately before epidural placement, subjects marked a VNRS score during an active contraction and parturients with VNRS ≥ 50 were included Cervical dilatation < 5 cm Exclusion Criteria: Contraindications to regional anesthesia Refuse to participate No pain Severe systemic disease (kidney, liver, pulmonary, endocrine, cardiac) Conditions associated with an increased risk of a cesarean delivery (i.e., history of uterine anomaly or surgery) and vaginal birth after cesarean delivery

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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group 1<br>Normal weight BMI 20-24.9 kg/m2 | Other: Dural puncture epidural<br>* Parturients, between 18 and 45 years of age, with cervical dilation less than 5 cm were consented to receive a DPE technique, with a single dural puncture with a 26-gauge spinal needle. After successful placement of the epidural catheter and puncturing the dura; 20 mL of bupivacaine 0.25% was administered through the epidural catheter and a patient-controlled epidural infusion of bupivacaine was initiated.<br>|
| Active Comparator: Group 2<br>Morbid Obese BMI : 40-49.9 kg/m2 | Other: Dural puncture epidural<br>* Parturients, between 18 and 45 years of age, with cervical dilation less than 5 cm were consented to receive a DPE technique, with a single dural puncture with a 26-gauge spinal needle. After successful placement of the epidural catheter and puncturing the dura; 20 mL of bupivacaine 0.25% was administered through the epidural catheter and a patient-controlled epidural infusion of bupivacaine was initiated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adequate analgesia | The primary outcome of this study is the incidence of patients having adequate analgesia (VNRS <30) at 5 minutes of epidural activation | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verbal numerical pain score scale ( 0 being no pain and 100 being the worst pain ) | Verbal numerical pain score (VNRS) (pain) was recorded before epidural (0 min baseline), at 5 min, 10 min, 15 min and then every 15 min till 1 hour and then every 30 min till delivery. | 6 hours | 
| Sensory level of DPE by pricking by blunt head of a pin | Was recorded before epidural (0 min-baseline), at 5 min, 10 min, 15 min and then every 15 min till 1 hour and then every 30 min till delivery. Sensory level of DPE was assessed by loss of sensation to prick by blunt head of a pin. | 6 hours | 
| Motor block Bromage score (1 being complete motor block and 6 being no motor block) | Motor strength was assessed with a modified Bromage score Was recorded before epidural (0 min baseline), at 5 min, 10 min, 15 min and then every 15 min till 1 hour and then every 30 min till delivery. | 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Morbid Obesity, Labor Pain