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Completed

NCT Number: NCT02369510

Does the Addition of Epinephrine Prolong the Duration of Spinal Anesthesia 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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-dose epinephrine

Drug

0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications

High-dose epinephrine

Drug

0.2ml of 1:1000 epinephrine will be added to the standard spinal medications

Other names: adrenaline

No epinephrine

Drug

0.2ml of preservative-free saline will be added to the standard spinal medications

Other names: preservative-free saline

Primary outcomes

  1. Sensory Recovery

    Time frame: up to 3 hours

    Time to T10 sensory recovery as measured by pinprick sensation

Secondary outcomes

  1. Motor Recovery

    Time frame: up to 4 hours

    Time to Bromage 3 motor recovery

  2. Block Onset

    Time frame: up to 15 min

    Time to a onset of T4 level of anesthesia or the highest level achieved in 15min

  3. Number of Participants With Hypotension

    Time frame: at 2 minutes and at 25 minutes

    Incidence of hypotension as measured by participants needing vasopressor agents

  4. 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.

  5. 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".

  6. Incidence of Nausea and Vomiting

    Time frame: up to 3 hours

  7. Incidence of Pruritus

    Time frame: up to 3 hours

    data not collected

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 24, 2015
Registry last updated
Aug 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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