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

Morbid Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04963452
• Other study ID #: R 149/2021
• Status: Completed
• Phase: N/A
• Start date: August 29, 2021
• Est. completion date: May 9, 2022

Study information

• Verified date: May 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 9, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

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.

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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