Does the Addition of Epinephrine Prolong the Duration of Spinal Anesthesia for Repeat Cesarean Section?

Cesarean Section Clinical Trial

Official title:

Does the Addition of Epinephrine Increase the Duration of Intrathecal Hyperbaric Bupivacaine for Repeat Cesarean Section?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02369510
• Other study ID #: GCO 14-2058
• Status: Completed
• Phase: Phase 4
• First received: February 17, 2015
• Last updated: August 28, 2017
• Start date: February 2015
• Est. completion date: May 2016

Study information

• Verified date: August 2017
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section
• Spinal Anesthesia

Intervention

Drug:
• Low-dose epinephrine
0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications
• High-dose epinephrine
0.2ml of 1:1000 epinephrine will be added to the standard spinal medications
• No epinephrine
0.2ml of preservative-free saline will be added to the standard spinal medications

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensory Recovery	Time to T10 sensory recovery as measured by pinprick sensation	up to 3 hours
Secondary	Motor Recovery	Time to Bromage 3 motor recovery	up to 4 hours
Secondary	Block Onset	Time to a onset of T4 level of anesthesia or the highest level achieved in 15min	up to 15 min
Secondary	Number of Participants With Hypotension	Incidence of hypotension as measured by participants needing vasopressor agents	at 2 minutes and at 25 minutes
Secondary	Adequacy of Anesthesia	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
Secondary	Patient Satisfaction	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
Secondary	Incidence of Nausea and Vomiting		up to 3 hours
Secondary	Incidence of Pruritus	data not collected	up to 3 hours