Clinical trial NCT02803450: Epidural Loading: High Volume, Low Concentration
Official title: Epidural Loading With High Volume, Low Concentration Prior to Catheter Insertion: is How You Administer the Volume Important?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Labor and Delivery
Keywords: Effects of; Anesthesia
spinal and epidural
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This prospective, randomized, single blinded control trial will investigate the effects of epidural loading with a high volume, low concentration local anesthetic solution via the epidural needle versus the epidural catheter.

Detailed description: This prospective, randomized, single blinded control trial will investigate the effects of epidural loading with a high volume, low concentration local anesthetic solution via the epidural needle versus the epidural catheter. Control patients will receive local anesthetic in lower volume more concentrated solution via the epidural catheter which is current standard practice. Outcome measures will include quantifying pain relief with respect to time using VAS scores. In addition, post delivery patient satisfaction regarding anesthesia regimen, blood pressure changes, heart rate, anesthetic level, total dose of epidural used during labor, rescue doses and incidence of fetal bradycardia will be assessed. 35 patients will be recruited for each of the three arms of the study, totaling 105 patients, in order to obtain significance when performing statistical analyses following complete enrollment in the study. The impetus of this study involves investigation of the effects of loading the epidural space with high volume, low concentration local anesthetic via two different modalities and studying which method is more efficacious.

Eligibility criteria: Inclusion Criteria:

1. Subjects who have volunteered and consented to participation in the study upon admission to labor and delivery
2. Parturients in active labor requesting epidural analgesia
3. Uncomplicated pregnancy with a reassuring fetal heart tracing
4. Age greater than or equal to 18 years

Exclusion Criteria:

1. Contraindication to epidural anesthesia
2. Inability to read, comprehend, and sign the informed consent form
3. Fetal intrauterine growth retardation (IUGR)
4. Non-reassuring fetal heart tracing
5. Cervical dilation greater than 7cm
6. Intra-uterine fetal demise
7. History of chronic pain other than in the back
8. Incarcerated patients I. Any patient enrolled in the study in whom there is evidence of dural puncture during epidural technique (\>3 attempts, presence of CSF)

j. Any evidence of high spinal after initial bolus or continuous infusion of high volume, low concentration local anesthetic solution k. Women undergoing cesarean section

Primary outcomes:
measure: Patient Pain Levels (VAS Assessment)
timeFrame: During Labor
measure: Patient Satisfaction
timeFrame: During labor
Secondary outcomes:
measure: Analgesic level
timeFrame: 20 minutes
measure: Maternal Vital Signs
timeFrame: 20 minutes
measure: Fetal Heart Rate
timeFrame: 20 minutes
measure: Rescue Bolus
timeFrame: During Labor
measure: Intravascular Catheter Placement
timeFrame: During labor
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: The Ohio State Univeristy
name: Goran Ristev, MD
role: PRINCIPAL_INVESTIGATOR
References: