Epidural Loading With High Volume, Low Concentration Prior to Catheter Insertion: is How You Administer the Volume Important?
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Labor and Delivery
- Sponsor
- Ohio State University
- Locations
- 1
- Primary Endpoint
- Patient Satisfaction
- Status
- Withdrawn
- Last Updated
- 4 years ago
Overview
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.
Investigators
Goran Ristev
Assistant Clinical Professor of Anesthesiology
Ohio State University
Eligibility Criteria
Inclusion Criteria
- •Subjects who have volunteered and consented to participation in the study upon admission to labor and delivery
- •Parturients in active labor requesting epidural analgesia
- •Uncomplicated pregnancy with a reassuring fetal heart tracing
- •Age greater than or equal to 18 years
Exclusion Criteria
- •Contraindication to epidural anesthesia
- •Inability to read, comprehend, and sign the informed consent form
- •Fetal intrauterine growth retardation (IUGR)
- •Non-reassuring fetal heart tracing
- •Cervical dilation greater than 7cm
- •Intra-uterine fetal demise
- •History of chronic pain other than in the back
- •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
Outcomes
Primary Outcomes
Patient Satisfaction
Time Frame: During labor
Patient satisfaction with analgesia using a Likert rating of patient satisfaction with anesthetic care.
Patient Pain Levels (VAS Assessment)
Time Frame: During Labor
Patients will be assessed for pain levels on the VAS scale after analgesia administration in both arms
Secondary Outcomes
- Analgesic level(20 minutes)
- Maternal Vital Signs(20 minutes)
- Fetal Heart Rate(20 minutes)
- Rescue Bolus(During Labor)
- Intravascular Catheter Placement(During labor)