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

NCT04963452 | Completed

• 1 other identifier: R 149/2021
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity

Keywords

Morbid Obesity; Labor Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Verbal numerical pain score scale ( 0 being no pain and 100 being the worst pain )

  6 hours

• Sensory level of DPE by pricking by blunt head of a pin

  6 hours

• Motor block Bromage score (1 being complete motor block and 6 being no motor block)

  6 hours

Study Arms (2)

Group 1

PLACEBO COMPARATOR

Normal weight BMI 20-24.9 kg/m2

Other: Dural puncture epidural

Group 2

ACTIVE COMPARATOR

Morbid Obese BMI : 40-49.9 kg/m2

Other: Dural puncture epidural

Interventions

Dural puncture epidural OTHER

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.

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Parturients undergoing normal vaginal delivery
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Obesity, Morbid; Labor Pain

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 15, 2021
• Study Start: August 29, 2021
• Primary Completion: April 15, 2022
• Study Completion: May 9, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)