Epidural Loading: High Volume, Low Concentration

Epidural Loading With High Volume, Low Concentration Prior to Catheter Insertion: is How You Administer the Volume Important?

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.

Study Overview

• Status: Withdrawn
• Conditions: Labor and Delivery
• Intervention / Treatment: Procedure: Epidural needle; Procedure: Catheter Administration; Procedure: Standard of Care Epidural Administration

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Volume, Low Concentration via Epidural Needle; Epidural loading: Participants will receive 20ml of 0.0625% bupivacaine with fentanyl 1mcg/ml epidural loading dose in 10ml increments five minutes apart via epidural needle followed by catheter placement. For continuous infusions: The continuous patient controlled epidural anesthesia (PCEA) pump will contain 0.03125% bupivacaine with 1mcg/ml fentanyl. The infusion rate will be set at 20ml/hr basal rate and 8ml every 15 minutes on demand with lockout of 52ml/hr. For inadequate analgesia: One additional 10ml boluses of the experimental 0.0625% bupivacaine with 1mcg/ml will be provided spaced 5 minutes apart via the epidural catheter.	Procedure: Epidural needle; Medication administration via epidural needle.
Experimental: High Volume, Low Concentration via Epidural Catheter; Epidural loading: Participants will receive 20ml of 0.0625% bupivacaine with fentanyl 1mcg/ml epidural loading dose in 10ml increments five minutes apart via the epidural catheter administration following catheter placement. For continuous infusions: The continuous patient controlled epidural anesthesia (PCEA) pump will contain 0.03125% bupivacaine with 1mcg/ml fentanyl. The infusion rate will be set at 20ml/hr basal rate and 8ml every 15 minutes on demand with lockout of 52ml/hr. For inadequate analgesia: One additional 10ml boluses of the experimental 0.0625% bupivacaine with 1mcg/ml will be provided spaced 5 minutes apart via the epidural catheter.	Procedure: Catheter Administration; Medication administration via epidural catheter.
Active Comparator: Low Volume, High Concentration via Epidural Catheter; Standard of Care Epidural Administration Epidural loading: Participants will receive 10ml of 0.125% bupivacaine with fentanyl 2mcg/ml in 5 ml increments 5 minutes apart via the epidural catheter following epidural catheter placement, per standard of care. For continuous infusions: The continuous patient controlled epidural anesthesia (PCEA) pump will contain 0.0625% bupivacaine with 2mcg/ml fentanyl. The infusion rate will be set at 10ml/hr basal rate and 4ml every 15 minutes on demand with lockout of 26ml/hr. For inadequate analgesia: One additional 5ml boluses of the standard 0.125% bupivacaine with 2mcg/ml will be provided spaced 5 minutes apart via the epidural catheter.	Procedure: Standard of Care Epidural Administration; Medication administered at higher concentration, lower volume via epidural catheter.; Other Names: Epidural catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Pain Levels (VAS Assessment)	Patients will be assessed for pain levels on the VAS scale after analgesia administration in both arms	During Labor
Patient Satisfaction	Patient satisfaction with analgesia using a Likert rating of patient satisfaction with anesthetic care.	During labor

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesic level	Pinprick every 10, 15, and 20 minutes following loading	20 minutes
Maternal Vital Signs	Measure change in maternal blood pressure and heart rate over 20 minutes following loading.	20 minutes
Fetal Heart Rate	Measure change in fetal heart rate following loading.	20 minutes
Rescue Bolus	Measure number of rescue bolus doses and total anesthetic dose	During Labor
Intravascular Catheter Placement	Measure incidence of intravascular catheter placement.	During labor

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Goran Ristev, MD, The Ohio State Univeristy

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: June 14, 2016
• First Submitted That Met QC Criteria: June 16, 2016
• First Posted (Estimate): June 17, 2016

Study Record Updates

• Last Update Posted (Actual): September 27, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Effects of; Anesthesia; spinal and epidural
• Other Study ID Numbers: 2013H0188

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO