Comparing Effectiveness of CSE Versus DPE for Labor Analgesia

Labor Pain Clinical Trial

Official title:

A Randomized Controlled Trial of Combined Spinal Epidural Versus Dural Puncture Epidural Techniques for Labor Analgesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05068661
• Other study ID #: Pro00108996
• Status: Completed
• Phase: Phase 4
• Start date: November 21, 2021
• Est. completion date: December 7, 2023

Study information

• Verified date: March 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 7, 2023
• Est. primary completion date: December 7, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor Pain

Intervention

Drug:
• Ropivacaine 0.1% Injectable Solution
DPE
• Bupivacaine 0.25% Injectable Solution
CSE

Locations

Country	Name	City	State
United States	Duke University Hospital	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From placement of epidural to delivery of baby, up to 32 hours
Secondary	Maternal adverse events	This will include instances such as: hypotension defined as 20% drop in blood pressure from admission blood pressure, fetal bradycardia, PDPH	From placement of epidural to delivery, up to 32 hours
Secondary	Incidence of motor block	Motor block assessed by the modified Bromage score will be completed every 2 hours	From placement of epidural to delivery, up to 32 hours
Secondary	Duration of the second stage of labor	Time from initiation of pushing to delivery of baby will be recorded	From start of second stage of labor to delivery, up to 6 hours
Secondary	Total labor epidural time	Time from placement of epidural to delivery will be recorded in anesthetic record	From placement of epidural to delivery, up to 32 hours
Secondary	Total anesthetic dose required	Total volume and concentration of local anesthetic will be recorded	From placement of epidural to delivery, up to 32 hours
Secondary	PCEA use	The number of demand doses and received doses will be recorded	From placement of epidural to delivery, up to 32 hours
Secondary	Mode of delivery	Spontaneous and assisted deliveries will be recorded	Through completion of the study, up to 32 hours from epidural placement
Secondary	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	From placement of epidural to delivery, up to 32 hours