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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04963452
Enrollment
64
Registered
2021-07-15
Start date
2021-08-29
Completion date
2022-05-09
Last updated
2022-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity

Keywords

Morbid Obesity, Labor Pain

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.

Interventions

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.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of adequate analgesia5 minutesThe primary outcome of this study is the incidence of patients having adequate analgesia (VNRS \<30) at 5 minutes of epidural activation

Secondary

MeasureTime frameDescription
Verbal numerical pain score scale ( 0 being no pain and 100 being the worst pain )6 hoursVerbal 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 pin6 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026