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

Not Applicable

Completed

• Conditions: Morbid Obesity
• Interventions: Other: Dural puncture epidural

• Registration Number: NCT04963452
• Lead Sponsor: Ain Shams University

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2021-07-06
• Study First Submitted QC: 2021-07-14
• Study First Posted: 2021-07-15
• Study Start: 2021-08-29
• Primary Completion: 2022-04-15
• Status Verified: 2022-05
• Study Completion: 2022-05-09
• Last Update Submitted: 2022-05-09
• Last Update Posted: 2022-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Dural puncture epidural	Normal weight BMI 20-24.9 kg/m2
Group 2	Dural puncture epidural	Morbid Obese BMI : 40-49.9 kg/m2

Primary Outcome Measures

Name	Time	Method
Incidence of adequate analgesia	5 minutes	The primary outcome of this study is the incidence of patients having adequate analgesia (VNRS \<30) at 5 minutes of epidural activation

Secondary Outcome Measures

Name	Time	Method
Verbal numerical pain score scale ( 0 being no pain and 100 being the worst pain )	6 hours	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.
Sensory level of DPE by pricking by blunt head of a pin	6 hours	* 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.
Motor block Bromage score (1 being complete motor block and 6 being no motor block)	6 hours	* 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.

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt