Epidural Loading: High Volume, Low Concentration

NCT ID: NCT02803450

Last Updated: 2021-09-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-01-31

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.

Conditions

Labor and Delivery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Epidural needle

Intervention Type: PROCEDURE

Medication administration via epidural needle.

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.

Group Type: EXPERIMENTAL

Catheter Administration

Intervention Type: PROCEDURE

Medication administration via epidural catheter.

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care Epidural Administration

Intervention Type: PROCEDURE

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

Interventions

Epidural needle

Medication administration via epidural needle.

Intervention Type: PROCEDURE

Catheter Administration

Medication administration via epidural catheter.

Intervention Type: PROCEDURE

Standard of Care Epidural Administration

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

Intervention Type: PROCEDURE

Other Intervention Names

Epidural catheter

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Goran Ristev

Assistant Clinical Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Goran Ristev, MD

Role: PRINCIPAL_INVESTIGATOR

The Ohio State Univeristy

Locations

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2013H0188

Identifier Type: -

Identifier Source: org_study_id