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

Ain Shams University

Status: Completed

Conditions: Morbid Obesity

Treatments: Other: Dural puncture epidural

Study type: Interventional

Funder types: Other

Identifiers

NCT04963452

R 149/2021

Details and patient eligibility

About

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.

Full description

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

Enrollment: 64 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 - 45 years old,
2. Physical status American society of anesthesiology (ASA) II,
3. Singleton,
4. Vertex fetuses at 37-41 weeks' gestation,
5. Nulliparous and multiparous women,
6. Immediately before epidural placement, subjects marked a VNRS score during an active contraction and parturients with VNRS ≥ 50 were included
7. Cervical dilatation < 5 cm

Exclusion criteria

1. Contraindications to regional anesthesia
2. Refuse to participate
3. No pain
4. Severe systemic disease (kidney, liver, pulmonary, endocrine, cardiac)
5. Conditions associated with an increased risk of a cesarean delivery (i.e., history of uterine anomaly or surgery) and vaginal birth after cesarean delivery

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 2 patient groups, including a placebo group

Group 1

Placebo Comparator group

Description:

Normal weight BMI 20-24.9 kg/m2

Treatment:

Other: Dural puncture epidural

Group 2

Active Comparator group

Description:

Morbid Obese BMI : 40-49.9 kg/m2

Treatment:

Other: Dural puncture epidural