Does the Addition of Epinephrine Prolong the Duration of Spinal Anesthesia for Repeat Cesarean Section?
- Conditions
- Cesarean SectionSpinal Anesthesia
- Interventions
- Registration Number
- NCT02369510
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- Brief Summary
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.
- Detailed Description
Spinal anesthesia with bupivacaine is a commonly used anesthetic in the obstetric population. It is most frequently carried out as a single shot intrathecal injection. This method can be utilized for both labor analgesia and surgical anesthesia for cesarean section. One of the concerns in using a single shot spinal injection for surgical anesthesia is the duration of adequate surgical conditions. This concern is especially relevant to repeat cesarean sections, as each subsequent procedure has the potential to be more complex than the prior and, therefore, prolonged. A reliable way to prolong surgical anesthesia provided by single shot spinal injection of bupivacaine could prove invaluable in the setting of repeat cesarean section. It has been well documented that adding epinephrine to intrathecal lidocaine will increase its duration1, but the evidence for augmenting the duration of anesthesia provided by adding epinephrine to bupivacaine is much more equivocal and less robust. This is a randomized control trial investigating whether or not adding epinephrine to a standard single intrathecal injection of hyperbaric bupivacaine for repeat cesarean will prolong its duration. It will be investigated using women who are undergoing scheduled repeat cesarean section in whom neuraxial anesthesia is the appropriate primary anesthetic. The investigators will compare the onset, quality and duration of both sensory and motor components of the spinal block as well as the incidence of known side effects.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 68
- Non-emergent repeat cesarean section
- Neuraxial anesthesia as the planned primary anesthetic
- Informed consent obtained
- Females age 18-50
- Emergency cesarean section
- Anesthetic other than neuraxial
- Allergy to local anesthetics, morphine, or epinephrine
- Pre-existing sensory/motor deficit
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low-dose epinephrine Low-dose epinephrine 100micrograms of epinephrine group High-dose epinephrine High-dose epinephrine 200micrograms of epinephrine group No epinephrine No epinephrine 0.2ml saline
- Primary Outcome Measures
Name Time Method Sensory Recovery up to 3 hours Time to T10 sensory recovery as measured by pinprick sensation
- Secondary Outcome Measures
Name Time Method Motor Recovery up to 4 hours Time to Bromage 3 motor recovery
Adequacy of Anesthesia 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.
Patient Satisfaction 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".
Incidence of Nausea and Vomiting up to 3 hours Incidence of Pruritus up to 3 hours data not collected
Block Onset up to 15 min Time to a onset of T4 level of anesthesia or the highest level achieved in 15min
Number of Participants With Hypotension at 2 minutes and at 25 minutes Incidence of hypotension as measured by participants needing vasopressor agents
Trial Locations
- Locations (1)
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States