NCT03915574

Brief Summary

This study will compare two anesthetics techniques called Dural Puncture Epidural (DPE) and Standard Epidural as to which of the two can provide faster and potentially better at providing pain relief for cesarean sections. It will also compare these two anesthetics techniques on the percentage of women who require additional drugs to control pain during their cesarean deliveries. The results of this study will help anesthesiologists know which anesthetic technique can provide faster and potentially better at providing pain relief for cesarean sections.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
23 days until next milestone

Study Start

First participant enrolled

May 9, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
8 months until next milestone

Results Posted

Study results publicly available

December 1, 2023

Completed
Last Updated

December 1, 2023

Status Verified

October 1, 2023

Enrollment Period

3.4 years

First QC Date

April 4, 2019

Results QC Date

October 3, 2023

Last Update Submit

November 29, 2023

Conditions

Pain Levels

Outcome Measures

Primary Outcomes (1)

  • Onset Time of Surgical Anesthesia

    The primary outcome will be the onset time of surgical anesthesia in seconds. This will be measured from the induction of anesthesia (as defined by the beginning of injection of the "Induction 1 syringe") to the point at which sharp sensation is lost bilaterally at the T6 dermatomal level (as measured by a blunt plastic neurotip® (Owen Mumford, USA) device)

    2 hours

Secondary Outcomes (1)

  • Number of Participants With Inadequate Neuraxial Analgesia or Anesthesia

    2 hours

Other Outcomes (11)

  • Maximum Pain During Surgery (Score)

    2 hours

  • Cumulative Dose of Phenylephrine Measured in Milligram Required During Surgery

    2 hours

  • Patient Satisfaction With Anesthetic Technique (Score)

    4 hours

  • +8 more other outcomes

Study Arms (2)

Dural Puncture Epidural

EXPERIMENTAL

Participants will receive a dural puncture epidural block with a 25 gauge spinal needle followed by a standard epidural infusion (0.0625% bupivacaine + 2mcg/ml fentanyl)

Device: 25G Dural Puncture Epidural

Standard Epidural

ACTIVE COMPARATOR

Participants will have standard epidural infusion followed by a standard epidural infusion (0.0625% bupivacaine + 2mcg/ml fentanyl)

Device: Standard Epidural

Interventions

25G Dural Puncture EpiduralDEVICE

Dural puncture created with a 25 gauge spinal needle

Dural Puncture Epidural
Standard EpiduralDEVICE

Control group - standard epidural (no dural puncture)

Standard Epidural

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Singleton pregnancy
  • Gestation \> 36 weeks
  • ASA class II and III
  • Provides written consent
  • Infant of mother
  • Elective or non-urgent cesarean delivery

You may not qualify if:

  • Patient refusal
  • Urgent/emergent cesarean sections
  • ASA and IV or above
  • Unable to understand English
  • Significant back surgery or scoliosis
  • Lethal fetal abnormality or likely to affect APGAR scores
  • Weight \> 120 kg
  • Height \< 150 cm
  • Allergy to study solutions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72204, United States

Location

Related Publications (1)

  • Sharawi N, Williams M, Athar W, Martinello C, Stoner K, Taylor C, Guo N, Sultan P, Mhyre JM. Effect of Dural-Puncture Epidural vs Standard Epidural for Epidural Extension on Onset Time of Surgical Anesthesia in Elective Cesarean Delivery: A Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2326710. doi: 10.1001/jamanetworkopen.2023.26710.

    PMID: 37526934DERIVED

Results Point of Contact

Title
Nadir Sharawi
Organization
UAMS
nelsharawi@uams.edu
5016866119

Study Officials

  • Nadir Sharawi, MD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 140 mother-infant dyads (280 actual participants)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2019

First Posted

April 16, 2019

Study Start

May 9, 2019

Primary Completion

October 12, 2022

Study Completion

April 1, 2023

Last Updated

December 1, 2023

Results First Posted

December 1, 2023

Record last verified: 2023-10

Locations

US(1)