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Cesarean Delivery and Post-operative Pain Management With Local Anesthesia

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ClinicalTrials.gov Identifier: NCT00298571
Recruitment Status : Completed
First Posted : March 2, 2006
Last Update Posted : June 15, 2012
Sponsor:
Information provided by (Responsible Party):
University of South Florida

Study Description
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Brief Summary:
The use of .5% Bupivacaine with epinephrine at the time of skin closure in cesarean deliveries will decrease post-op pain.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: .5% bupivacaine with epinephrine Phase 2 Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : February 2006
Actual Study Completion Date : October 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 1. Decreased post-op pain
  2. 2. Decreased post-op narcotic use

Secondary Outcome Measures :
  1. improved hospital stay satisfaction

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant Women with scheduled cesarean delivery
  • able to perform informed consent

Exclusion Criteria:

  • Labor
  • chronic pain
  • allergic to local anesthetic
  • unable to perform informed consent
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00298571


Locations
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United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33606
Sponsors and Collaborators
University of South Florida
Investigators
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Study Director: Shelly Holmstrom, MD USF Department OB/Gyn
More Information
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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT00298571     History of Changes
Other Study ID Numbers: 1212
First Posted: March 2, 2006    Key Record Dates
Last Update Posted: June 15, 2012
Last Verified: February 2006
Keywords provided by University of South Florida:
Cesarean Delivery
Post-operative
Pain
Local Anesthetic
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Epinephrine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
 Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents