Epidural Loading: High Volume, Low Concentration

NCT02803450 | Withdrawn

• 1 other identifier: 2013H0188
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor and Delivery

Keywords

Effects of; Anesthesia; spinal and epidural

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Analgesic level

  20 minutes

• Maternal Vital Signs

  20 minutes

• Fetal Heart Rate

  20 minutes

• Rescue Bolus

  During Labor

• Intravascular Catheter Placement

  During labor

Study Arms (3)

High Volume, Low Concentration via Epidural Needle

EXPERIMENTAL

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

High Volume, Low Concentration via Epidural Catheter

EXPERIMENTAL

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

Low Volume, High Concentration via Epidural Catheter

ACTIVE COMPARATOR

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

Interventions

Epidural needle PROCEDURE

Medication administration via epidural needle.

High Volume, Low Concentration via Epidural Needle

Catheter Administration PROCEDURE

Medication administration via epidural catheter.

High Volume, Low Concentration via Epidural Catheter

Standard of Care Epidural Administration PROCEDURE

Medication administered at higher concentration, lower volume via epidural catheter.

Also known as: Epidural catheter

Low Volume, High Concentration via Epidural Catheter

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Study Officials

• Goran Ristev, MD

  The Ohio State Univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor of Anesthesiology

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 17, 2016
• Study Start: February 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: September 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)