- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02369510
Does the Addition of Epinephrine Prolong the Duration of Spinal Anesthesia for Repeat Cesarean Section?
Does the Addition of Epinephrine Increase the Duration of Intrathecal Hyperbaric Bupivacaine for Repeat Cesarean Section?
The purpose of this study is to investigate whether the addition of a medication called epinephrine to spinal medications prolongs the duration of the anesthesia. The medication standardly used in spinal anesthesia is a local anesthetic (bupivacaine) and an opiate pain medication (morphine). These medications typically last about 2 hours. The investigators want to determine if adding epinephrine to the spinal medications prolongs the anesthetic without side effects. A longer duration of anesthesia may be useful in prolonged repeat cesarean section. Epinephrine is known to prolong the action of some local anesthetics, but the investigators want to specifically study combining it with the medications the investigators use regularly for cesarean section.
You may qualify to take part in this research study because you are having a repeat cesarean section. Repeat cesarean sections sometimes last longer than 2 hours. The investigators want to determine if epinephrine will prolong the anesthetic.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Non-emergent repeat cesarean section
- Neuraxial anesthesia as the planned primary anesthetic
- Informed consent obtained
- Females age 18-50
Exclusion Criteria:
- Emergency cesarean section
- Anesthetic other than neuraxial
- Allergy to local anesthetics, morphine, or epinephrine
- Pre-existing sensory/motor deficit
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low-dose epinephrine
100micrograms of epinephrine group
|
0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications
|
Experimental: High-dose epinephrine
200micrograms of epinephrine group
|
0.2ml of 1:1000 epinephrine will be added to the standard spinal medications
Other Names:
|
Placebo Comparator: No epinephrine
0.2ml saline
|
0.2ml of preservative-free saline will be added to the standard spinal medications
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensory Recovery
Time Frame: up to 3 hours
|
Time to T10 sensory recovery as measured by pinprick sensation
|
up to 3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motor Recovery
Time Frame: up to 4 hours
|
Time to Bromage 3 motor recovery
|
up to 4 hours
|
Block Onset
Time Frame: up to 15 min
|
Time to a onset of T4 level of anesthesia or the highest level achieved in 15min
|
up to 15 min
|
Number of Participants With Hypotension
Time Frame: at 2 minutes and at 25 minutes
|
Incidence of hypotension as measured by participants needing vasopressor agents
|
at 2 minutes and at 25 minutes
|
Adequacy of Anesthesia
Time Frame: up to 3 hrs
|
As measured by pinprick sensation and/or patient discomfort as measured by verbal pain score on a scale of 0=no pain to 10=worst imaginable pain, obtained within 3 hours of receiving anesthesia.
|
up to 3 hrs
|
Patient Satisfaction
Time Frame: up to 3 hours
|
Patient satisfaction score was elicited upon arrival to the recovery room on a 1-5 Likert scale.
Number of participants selecting the highest score of 5 or "completely satisfied".
|
up to 3 hours
|
Incidence of Nausea and Vomiting
Time Frame: up to 3 hours
|
up to 3 hours
|
|
Incidence of Pruritus
Time Frame: up to 3 hours
|
data not collected
|
up to 3 hours
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Epinephrine
- Racepinephrine
- Epinephryl borate
Other Study ID Numbers
- GCO 14-2058
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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