Trials / Withdrawn
WithdrawnNCT02803450
Epidural Loading: High Volume, Low Concentration
Epidural Loading With High Volume, Low Concentration Prior to Catheter Insertion: is How You Administer the Volume Important?
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Ohio State University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 89 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Epidural needle | Medication administration via epidural needle. |
| PROCEDURE | Catheter Administration | Medication administration via epidural catheter. |
| PROCEDURE | Standard of Care Epidural Administration | Medication administered at higher concentration, lower volume via epidural catheter. |
Timeline
- Start date
- 2016-02-01
- Primary completion
- 2017-01-01
- Completion
- 2017-01-01
- First posted
- 2016-06-17
- Last updated
- 2021-09-27
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02803450. Inclusion in this directory is not an endorsement.