Status:
COMPLETED
Epidural Volume Extension During a Combined Spinal-Epidural Technique for Labor Analgesia.
Lead Sponsor:
IWK Health Centre
Conditions:
Pregnancy
Labor Pain
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Combined spinal-epidurals (CSE) involve the injection of pain relief medication into the cerebral spinal fluid (CSF) and the insertion of an epidural catheter in the epidural space to continue to give...
Detailed Description
Regional analgesia (pain relief) for labor can be an epidural, a spinal or a combination of the two. Combined spinal-epidurals (CSE) are popular because of their rapid pain relief and high patient sat...
Eligibility Criteria
Inclusion
- Nulliparous parturients requesting regional analgesia for labour pain with singleton, vertex presentation fetuses at 37-42 week gestation in active labor with cervical dilation \< 5 cm.
- American Society of Anesthesia physical status class I \& II (ASA I - Healthy, ASA II - mild and controlled systemic disease, e.g. controlled essential hypertension)
- Age ≥ 18 years (Standard within the obstetrical anesthesia literature)
- English-speaking
Exclusion
- Contraindications to neuraxial analgesia (i.e. coagulopathy, systemic infection, neuropathy)
- Conditions associated with abnormal spinal anatomy which can affect local anesthetic spread (i.e. scoliosis, spina bifida, spinal instrumentation)
- Conditions associated with an increased risk of a cesarean delivery (i.e., history of uterine anomaly or surgery, morbid obesity (Body Mass Index ≥ 35 kg/m2)
- Clinically significant diseases of pregnancy such as pregnancy-induced hypertension or preeclampsia (defined as systolic blood pressure (SBP) \> 160mmHg, diastolic blood pressure (DBP) \> 110mmHg and/or requiring antihypertensive treatment or associated with significant proteinuria)
- Severe maternal cardiac disease
- Known fetal anomalies /intrauterine fetal demise
- Patient enrollment in another study involving a study medication within 30 days
- Any other physical or psychiatric condition which may impair their ability to cooperate with study data collection
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01810406
Start Date
March 1 2013
Last Update
April 23 2014
Active Locations (1)
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1
Women's and Obstetric Anesthesia, IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8