Sponsor study identifier
interventional
0
1 country
1
Study Start
February 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2017
Actual (reported)Study Completion
January 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2016
Date type not reportedThis date has not been verified as actual or estimated.
June 14, 2016
Actual (reported)June 17, 2016
Actual (reported)January 2017
Actual (reported)January 2017
Actual (reported)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
Analgesic level
20 minutes
Maternal Vital Signs
20 minutes
Fetal Heart Rate
20 minutes
Rescue Bolus
During Labor
Intravascular Catheter Placement
During labor
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.
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.
Medication administration via epidural needle.
Medication administration via epidural catheter.
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Goran Ristev, MD
The Ohio State Univeristy
0 participants (actual enrollment reported by the registry).
First Submitted
June 14, 2016
First Posted
June 17, 2016
Study Start
February 2016
Date type not reportedThis date has not been verified as actual or estimated.
Epidural Loading Prior to Catheter Insertion
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.
Medication administered at higher concentration, lower volume via epidural catheter.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
January 2017
Actual (reported)Study Completion
January 2017
Actual (reported)Last Updated
September 27, 2021
Record last verified: 2021-09
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Source: ClinicalTrials.gov.
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