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

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dural puncture epidural
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Morbid Obesity focused on measuring Morbid Obesity, Labor Pain

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Ain Shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

Normal weight BMI 20-24.9 kg/m2

Morbid Obese BMI : 40-49.9 kg/m2

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
July 6, 2021
Last Updated
May 9, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04963452
Brief Title
Does Body Mass Index Impact the Outcome of Dural Puncture Epidural in Parturients Undergoing Normal Vaginal Delivery
Official Title
Does Body Mass Index Impact the Outcome of Dural Puncture Epidural in Parturients Undergoing Normal Vaginal Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
August 29, 2021 (Actual)
Primary Completion Date
April 15, 2022 (Actual)
Study Completion Date
May 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Morbid Obesity, Labor Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Placebo Comparator
Arm Description
Normal weight BMI 20-24.9 kg/m2
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Morbid Obese BMI : 40-49.9 kg/m2
Intervention Type
Other
Intervention Name(s)
Dural puncture epidural
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of adequate analgesia
Description
The primary outcome of this study is the incidence of patients having adequate analgesia (VNRS <30) at 5 minutes of epidural activation
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Verbal numerical pain score scale ( 0 being no pain and 100 being the worst pain )
Description
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.
Time Frame
6 hours
Title
Sensory level of DPE by pricking by blunt head of a pin
Description
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.
Time Frame
6 hours
Title
Motor block Bromage score (1 being complete motor block and 6 being no motor block)
Description
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.
Time Frame
6 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Parturients undergoing normal vaginal delivery
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ain Shams University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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