NCT02369510

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 24, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

August 30, 2017

Completed
Last Updated

August 30, 2017

Status Verified

August 1, 2017

Enrollment Period

1.2 years

First QC Date

February 17, 2015

Results QC Date

May 1, 2017

Last Update Submit

August 28, 2017

Conditions

Spinal AnesthesiaCesarean Section

Keywords

spinal anesthesiaepinephrinebupivacainerepeat cesarean

Outcome Measures

Primary Outcomes (1)

  • Sensory Recovery

    Time to T10 sensory recovery as measured by pinprick sensation

    up to 3 hours

Secondary Outcomes (7)

  • Motor Recovery

    up to 4 hours

  • Block Onset

    up to 15 min

  • Number of Participants With Hypotension

    at 2 minutes and at 25 minutes

  • Adequacy of Anesthesia

    up to 3 hrs

  • Patient Satisfaction

    up to 3 hours

  • +2 more secondary outcomes

Study Arms (3)

Low-dose epinephrine

EXPERIMENTAL

100micrograms of epinephrine group

Drug: Low-dose epinephrine

High-dose epinephrine

EXPERIMENTAL

200micrograms of epinephrine group

Drug: High-dose epinephrine

No epinephrine

PLACEBO COMPARATOR

0.2ml saline

Drug: No epinephrine

Interventions

Low-dose epinephrineDRUG

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

Low-dose epinephrine
High-dose epinephrineDRUG

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

Also known as: adrenaline
High-dose epinephrine
No epinephrineDRUG

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

Also known as: preservative-free saline
No epinephrine

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Non-emergent repeat cesarean section
  • Neuraxial anesthesia as the planned primary anesthetic
  • Informed consent obtained
  • Females age 18-50

You may not qualify if:

  • Emergency cesarean section
  • Anesthetic other than neuraxial
  • Allergy to local anesthetics, morphine, or epinephrine
  • Pre-existing sensory/motor deficit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

  • 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.

    PMID: 29077615DERIVED

MeSH Terms

Interventions

Epinephrine

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Results Point of Contact

Title
Dr. Daniel Katz
Organization
Icahn School of Medicine at Mount Sinai
Daniel.Katz@MountSinai.org
212-241-7475

Study Officials

  • Daniel Katz, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

  • Yaakov Beilin, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesiology

Study Record Dates

First Submitted

February 17, 2015

First Posted

February 24, 2015

Study Start

February 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

August 30, 2017

Results First Posted

August 30, 2017

Record last verified: 2017-08

Locations

US(1)