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

August 28, 2017 updated by: Daniel Katz, Icahn School of Medicine at Mount Sinai

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

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.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • adrenaline
Placebo Comparator: No epinephrine
0.2ml saline
0.2ml of preservative-free saline will be added to the standard spinal medications
Other Names:
  • preservative-free saline

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

February 17, 2015

First Submitted That Met QC Criteria

February 23, 2015

First Posted (Estimate)

February 24, 2015

Study Record Updates

Last Update Posted (Actual)

August 30, 2017

Last Update Submitted That Met QC Criteria

August 28, 2017

Last Verified

August 1, 2017

More Information

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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