Dural Puncture Epidural Versus Epidural Anesthesia for Cesarean Delivery

Dural Puncture Epidural Versus Epidural Anesthesia for Cesarean Delivery: A Randomized, Double-blind Study

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.

Study Overview

• Status: Completed
• Conditions: Pain Levels
• Intervention / Treatment: Device: 25G Dural Puncture Epidural; Device: Standard Epidural

Detailed Description

The aim of this study is to compare the onset time of anesthesia between standard epidural and Dural Puncture Epidural (DPE) for cesarean delivery. The study will hypothesize that a DPE technique with a 25-gauge spinal needle will have a faster onset and improved quality of surgical anesthesia when compared to a standard epidural. Participants will be blinded to which group they are being assigned. An unblinded anesthesiologist will insert the epidural or DPE based on randomization. After insertion of the epidural or DPE, a low dose local anesthetic infusion will be infused into the epidural catheter up until the time of surgery. This is the standard infusion used to provide pain relief in laboring women (bupivacaine 0.0625% with 2 mcg/ml fentanyl). In this way participants enrolled in the study would mimic anesthetic the conditions of a "labor epidural".

Participants will then move on to the next phase of the study. In this phase, the epidural pump will be discontinued, and anesthesia care will be conducted in the same manner as all cesarean deliveries under epidural extension anesthesia (this refers to the process of providing anesthesia using a pre-existing epidural/DPE that was inserted for the purpose of providing labor analgesia). Anesthesia will be induced in a standardized manner with 20 ml of 3% chloroprocaine. Motor and sensory block will be tested at the end of the epidural loading dose. Loss of sharp sensation will be measured using a blunt plastic neurotip® (Owen Mumford, USA) until a sensory bilateral block to the T6 dermatomal level has been reached. The T6 level measured at the xiphoid process will be marked bilaterally with a washable marker pen to guarantee the precision of the primary endpoint (which will be assumed when sensory block goes above T6). Sensory testing will be performed from caudad to cephalad (i.e. from blocked to unblocked dermatomes) to identify the first unblocked dermatome. To identify the level where the sensation of touch is first appreciated, the investigator will ask the question: "Tell me when you feel the sensation of something sharp touching your skin." Both the motor and sensory block evaluations are part of the standard clinical care of patients receiving neuraxial anesthesia. The main difference for participants enrolled in the study is that the frequency of sensory assessments will be increased so that the onset of surgical anesthesia can be accurately documented (approximately every minute and then more frequently as the sensory block approaches the primary endpoints). A second anesthesiologist, blind to the type of block will manage the clinical care of the patient from the beginning of the study (after epidural catheter placement) and will administer the induction drug (prepared by that anesthesiologist as per SOC). There will be no difference in this clinician's care of the subject than if she were not enrolled in the study. This will assess the onset of anesthesia and manage all aspects of the subject's clinical care including the documentation of the local anesthetic (LA) solution administration timing and its clinical effects. The speed of onset will be assessed from the end of epidural test dose. This will be defined as time zero and the start of anesthesia. If required, intra-operative analgesia will be offered in the form of further epidural top-up, intravenous fentanyl, ketamine, nitrous oxide or replacement of neuraxial anesthesia/conversion into general anesthesia as the standard of care (SOC).

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caesar A Guevara; Phone Number: 501-526-5879; Email: CAGuevara@uams.edu
• Study Contact Backup: Name: Nadir Sharawi, MD; Phone Number: 501-319-2622; Email: NElsharawi@uams.edu

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72204
      • University of Arkansas for Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dural Puncture Epidural; 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; Dural puncture created with a 25 gauge spinal needle
Active Comparator: Standard Epidural; Participants will have standard epidural infusion followed by a standard epidural infusion (0.0625% bupivacaine + 2mcg/ml fentanyl)	Device: Standard Epidural; Control group - standard epidural (no dural puncture)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Inadequate Neuraxial Analgesia or Anesthesia	A composite outcome defined by failure to achieve at least a T10 bilateral sensory level pre-operatively (after 3 ml 1.5% lidocaine with 1:200,000 epinephrine 45 mg lidocaine and up to 20 ml of 0.0625% bupivacaine with 2mcg/ml fentanyl), the requirement for intraoperative analgesia supplementation, conversion to general anesthesia or repeat neuraxial procedure, or failure to achieve the primary outcome within 15 minutes between the two groups. Analyzed as a collapsed composite (any or none)	2 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Pain During Surgery (Score)	Maximum pain visual analogue scale during surgery (units on a scale, 0 - 10)	2 hours
Cumulative Dose of Phenylephrine Measured in Milligram Required During Surgery	Vasopressor requirements during surgery required to maintain systolic blood pressure within 15% of baseline	2 hours
Patient Satisfaction With Anesthetic Technique (Score)	Overall patient satisfaction score (units on a scale, 0 - 10)	4 hours
Neonatal Requirement for Resuscitation	Neonatal Apgar scores (units on a scale, 0 - 10)	2 hours
Neonatal Physiological Condition	Umbilical cord blood gases (pH measurement)	2 hours
Requirement for Opioids in the First 24 Hours After Surgery	Opioid consumption measured in milligrams.	24 hours
Anesthesia Side Effects	nausea, vomiting, itching (yes/no)	2 hours
Vasopressor Requirements During Surgery	measured in milligrams	2 hours
Bromage Score (0 - 3 Scale)	Motor block assessment 0 - Able to move hip, knee, and ankle; - unable to move hip, but able to move knee and ankle; - unable to move hip and knee, but able to move ankle; - unable to move hip, knee and ankle	3 hours
Sensory Block Assessment	Assessed using sharp sensation at the midclavicular line on the abdomen and thorax Reported at the dermatomal level where sharp sensation is first felt	3 hours
Anesthesia Adverse Effects	Accidental dural puncture, local anesthesia systemic toxicity, high spinal, post dural puncture headache	24 hours

Collaborators and Investigators

• Sponsor: University of Arkansas
• Investigators: Principal Investigator: Nadir Sharawi, MD, University of Arkansas

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2019
• Primary Completion (Actual): October 12, 2022
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: April 11, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 228768

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No