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Comparing Effectiveness of CSE Versus DPE for Labor Analgesia

Primary Purpose

Labor Pain

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine 0.1% Injectable Solution
Bupivacaine 0.25% Injectable Solution
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring labor analgesia, neuraxial technique, combined spinal epidural, dural puncture epidural

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Ages 18-45, singleton, vertex fetuses at 37-41 weeks' gestation, nulliparous and multiparous women, cervical dilation of 2-7cm, pain score > 4, and English-speaking ability

Exclusion Criteria:

  • Women with major cardiac disease, chronic pain, chronic opioid use

Sites / Locations

  • Duke University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Combined Spinal Epidural

Dural Puncture Epidural

Arm Description

10 mcg of preservative-free fentanyl and 2 mg of preservative-free isobaric 0.25% bupivacaine will be administered into the intrathecal space to initiate analgesia. Labor analgesia will be maintained by programmed intermittent bolus with patient-controlled epidural analgesia (PCEA) as per standard of care.

A 25-G Whitacre needle will be used to puncture the dura. An initiation dose of 20 mL of ropivacaine 0.1% with fentanyl (2 mcg/mL) will be administered. Labor analgesia will be maintained by programmed intermittent bolus with patient-controlled epidural analgesia (PCEA) as per standard of care.

Outcomes

Primary Outcome Measures

Block quality as defined by a composite of five components
The primary outcome of this study is block quality which will be defined by a composite of five components (1) asymmetric block after 30 minutes of initiation, (2) top-up interventions, (3) catheter adjustments (4) failed catheter requiring replacement, and (5) failed epidural requiring general anesthesia or replacement neuraxial anesthesia for cesarean section.

Secondary Outcome Measures

Time to numeric pain rating scale ≤1
After placement and dosing of CSE or DPE, pain scores will be evaluated every 3 minutes for 30 minutes.
Maternal adverse events
This will include instances such as: hypotension defined as 20% drop in blood pressure from admission blood pressure, fetal bradycardia, PDPH
Incidence of motor block
Motor block assessed by the modified Bromage score will be completed every 2 hours
Duration of the second stage of labor
Time from initiation of pushing to delivery of baby will be recorded
Total labor epidural time
Time from placement of epidural to delivery will be recorded in anesthetic record
Total anesthetic dose required
Total volume and concentration of local anesthetic will be recorded
PCEA use
The number of demand doses and received doses will be recorded
Mode of delivery
Spontaneous and assisted deliveries will be recorded
Postpartum: Satisfaction with analgesia overall
Patient satisfaction scores will be recorded from scale of 0 to 10, with 10 being the highest level of satisfaction

Full Information

First Posted
September 13, 2021
Last Updated
March 6, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT05068661
Brief Title
Comparing Effectiveness of CSE Versus DPE for Labor Analgesia
Official Title
A Randomized Controlled Trial of Combined Spinal Epidural Versus Dural Puncture Epidural Techniques for Labor Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 21, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary purpose of this study is to determine if there are differences in block quality between the CSE and DPE techniques for labor analgesia in parturients in active labor. We hypothesize that when compared to the CSE technique, the DPE technique will significantly improve block quality in this population and require fewer "top-ups" and catheter replacements.
Detailed Description
This will be a prospective, double-blinded, randomized trial. Subject identification and recruitment: Women admitted to the Duke Birthing Center for spontaneous or induced labor will be screened. After usual consultation with the anesthesia team is completed and consent for anesthesia services are obtained, eligible patients will be approached to by a member of the study team. As indicated below, we will plan to enroll up to 120 patients to have 100 patients with complete data (50 for the CSE group and 50 for the DPE group). Assignment of Study Cohorts: Study participants will be randomized by computer-generated sequence to CSE or DPE arms, stratified by parity (nulliparous versus multiparous). After the consented and enrolled participant requests labor epidural, a study member will give the anesthesia provider a sealed envelope with study assignment for either standard CSE or DPE technique. Epidural technique: Once the patient requests labor analgesia, the usual standard of care for epidural placement will be initiated. The patient will receive 500-1000 mL fluid preload. Vitals will be monitored by the labor nurse, including continuous pulse oximetry, non-invasive blood-pressure monitoring, and external tocodynamometry. Anesthesia time-out will be performed by the anesthesia provider with participation from the nurse and the patient. All patients will receive a neuraxial technique in the sitting position at L3/4 or L4/5 using loss of resistance to saline. In both the CSE and DPE groups, a 25-G Whitacre needle will be used to puncture the dura. In the CSE group, 10 mcg of preservative-free fentanyl and 2 mg of preservative-free isobaric 0.25% bupivacaine will be administered into the intrathecal space. In both groups, the epidural catheter will be threaded 5 cm into the epidural space. In the DPE group, an initiation dose of 20 mL of ropivacaine 0.1% with fentanyl (2 mcg/mL) over 6 minutes. This would not be administered in the CSE group. Labor analgesia will be maintained by programmed intermittent bolus with 8 mL of the same solution every 45 minutes starting 30 minutes after the initial dose. Patients will have patient-controlled epidural analgesia (PCEA) available with an 10 mL dose per demand, every 10 minutes, for a maximum dose of 50 mL for every hour. Data Collection: After the block is placed, a blinded provider will enter the room to collect data. Data will be collected every 3 minutes for the first 30 minutes or until pain score is 1 or 0 with uterine contractions. Subsequent assessments will be every 2 hours until delivery. Management of breakthrough pain will be standardized.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
labor analgesia, neuraxial technique, combined spinal epidural, dural puncture epidural

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined Spinal Epidural
Arm Type
Active Comparator
Arm Description
10 mcg of preservative-free fentanyl and 2 mg of preservative-free isobaric 0.25% bupivacaine will be administered into the intrathecal space to initiate analgesia. Labor analgesia will be maintained by programmed intermittent bolus with patient-controlled epidural analgesia (PCEA) as per standard of care.
Arm Title
Dural Puncture Epidural
Arm Type
Active Comparator
Arm Description
A 25-G Whitacre needle will be used to puncture the dura. An initiation dose of 20 mL of ropivacaine 0.1% with fentanyl (2 mcg/mL) will be administered. Labor analgesia will be maintained by programmed intermittent bolus with patient-controlled epidural analgesia (PCEA) as per standard of care.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.1% Injectable Solution
Other Intervention Name(s)
Fentanyl
Intervention Description
DPE
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.25% Injectable Solution
Other Intervention Name(s)
Ropivacaine 0.1% Injectable Solution, Fentanyl
Intervention Description
CSE
Primary Outcome Measure Information:
Title
Block quality as defined by a composite of five components
Description
The primary outcome of this study is block quality which will be defined by a composite of five components (1) asymmetric block after 30 minutes of initiation, (2) top-up interventions, (3) catheter adjustments (4) failed catheter requiring replacement, and (5) failed epidural requiring general anesthesia or replacement neuraxial anesthesia for cesarean section.
Time Frame
From placement of epidural to delivery of baby, up to 32 hours
Secondary Outcome Measure Information:
Title
Time to numeric pain rating scale ≤1
Description
After placement and dosing of CSE or DPE, pain scores will be evaluated every 3 minutes for 30 minutes.
Time Frame
From placement of epidural to 30 minutes later
Title
Maternal adverse events
Description
This will include instances such as: hypotension defined as 20% drop in blood pressure from admission blood pressure, fetal bradycardia, PDPH
Time Frame
From placement of epidural to delivery, up to 32 hours
Title
Incidence of motor block
Description
Motor block assessed by the modified Bromage score will be completed every 2 hours
Time Frame
From placement of epidural to delivery, up to 32 hours
Title
Duration of the second stage of labor
Description
Time from initiation of pushing to delivery of baby will be recorded
Time Frame
From start of second stage of labor to delivery, up to 6 hours
Title
Total labor epidural time
Description
Time from placement of epidural to delivery will be recorded in anesthetic record
Time Frame
From placement of epidural to delivery, up to 32 hours
Title
Total anesthetic dose required
Description
Total volume and concentration of local anesthetic will be recorded
Time Frame
From placement of epidural to delivery, up to 32 hours
Title
PCEA use
Description
The number of demand doses and received doses will be recorded
Time Frame
From placement of epidural to delivery, up to 32 hours
Title
Mode of delivery
Description
Spontaneous and assisted deliveries will be recorded
Time Frame
Through completion of the study, up to 32 hours from epidural placement
Title
Postpartum: Satisfaction with analgesia overall
Description
Patient satisfaction scores will be recorded from scale of 0 to 10, with 10 being the highest level of satisfaction
Time Frame
From placement of epidural to delivery, up to 32 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women who have a singleton pregancy at 37-41 weeks' gestation
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages 18-45, singleton, vertex fetuses at 37-41 weeks' gestation, nulliparous and multiparous women, cervical dilation of 2-7cm, pain score > 4, and English-speaking ability Exclusion Criteria: Women with major cardiac disease, chronic pain, chronic opioid use
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashraf Habib, MD
Phone
919-681-4544
Email
ashraf.habib@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashraf S Habib, MD
Organizational Affiliation
Duke University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashraf Habib, MB BCh
Phone
919-681-4544
Email
ashraf.habib@duke.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparing Effectiveness of CSE Versus DPE for Labor Analgesia

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