Clinical trial NCT03915574: Dural Puncture Epidural Versus Epidural Anesthesia for Cesarean Delivery
Official title: Dural Puncture Epidural Versus Epidural Anesthesia for Cesarean Delivery: A Randomized, Double-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Levels
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 280
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 140 mother-infant dyads (280 actual participants)
Primary purpose: SUPPORTIVE_CARE

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Onset Time of Surgical Anesthesia
timeFrame: 2 hours
Secondary outcomes:
measure: Number of Participants With Inadequate Neuraxial Analgesia or Anesthesia
timeFrame: 2 hours
Other outcomes:
measure: Maximum Pain During Surgery (Score)
timeFrame: 2 hours
measure: Cumulative Dose of Phenylephrine Measured in Milligram Required During Surgery
timeFrame: 2 hours
measure: Patient Satisfaction With Anesthetic Technique (Score)
timeFrame: 4 hours
measure: Neonatal Requirement for Resuscitation
timeFrame: 2 hours
measure: Neonatal Physiological Condition
timeFrame: 2 hours
measure: Requirement for Opioids in the First 24 Hours After Surgery
timeFrame: 24 hours
measure: Anesthesia Side Effects
timeFrame: 2 hours
measure: Vasopressor Requirements During Surgery
timeFrame: 2 hours
measure: Bromage Score (0 - 3 Scale)
timeFrame: 3 hours
measure: Sensory Block Assessment
timeFrame: 3 hours
measure: Anesthesia Adverse Effects
timeFrame: 24 hours
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Nadir Sharawi, MD
role: PRINCIPAL_INVESTIGATOR
References: