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

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.

Study Overview

• Status: Completed
• Conditions: Morbid Obesity
• Intervention / Treatment: Other: Dural puncture epidural

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group 1; Normal weight BMI 20-24.9 kg/m2	Other: Dural puncture epidural; 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.
Active Comparator: Group 2; Morbid Obese BMI : 40-49.9 kg/m2	Other: Dural puncture epidural; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2021
• Primary Completion (Actual): April 15, 2022
• Study Completion (Actual): May 9, 2022

Study Registration Dates

• First Submitted: July 6, 2021
• First Submitted That Met QC Criteria: July 14, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Actual): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Morbid Obesity; Labor Pain
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: R 149/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No