Clinical trial NCT02369510: Does the Addition of Epinephrine Prolong the Duration of Spinal Anesthesia for Repeat Cesarean Section?
Official title: Does the Addition of Epinephrine Increase the Duration of Intrathecal Hyperbaric Bupivacaine for Repeat Cesarean Section?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spinal Anesthesia
Cesarean Section
Keywords: spinal anesthesia
epinephrine
bupivacaine
repeat cesarean
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2015-02-24
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensory Recovery
timeFrame: up to 3 hours
Secondary outcomes:
measure: Motor Recovery
timeFrame: up to 4 hours
measure: Block Onset
timeFrame: up to 15 min
measure: Number of Participants With Hypotension
timeFrame: at 2 minutes and at 25 minutes
measure: Adequacy of Anesthesia
timeFrame: up to 3 hrs
measure: Patient Satisfaction
timeFrame: up to 3 hours
measure: Incidence of Nausea and Vomiting
timeFrame: up to 3 hours
measure: Incidence of Pruritus
timeFrame: up to 3 hours
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Daniel Katz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Yaakov Beilin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Katz D, Hamburger J, Gutman D, Wang R, Lin HM, Marotta M, Zahn J, Beilin Y. The Effect of Adding Subarachnoid Epinephrine to Hyperbaric Bupivacaine and Morphine for Repeat Cesarean Delivery: A Double-Blind Prospective Randomized Control Trial. Anesth Analg. 2018 Jul;127(1):171-178. doi: 10.1213/ANE.0000000000002542.