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Cesarean Delivery and Post-operative Pain Management With Local Anesthesia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00298571
First Posted: March 2, 2006
Last Update Posted: June 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of South Florida
  Purpose
The use of .5% Bupivacaine with epinephrine at the time of skin closure in cesarean deliveries will decrease post-op pain.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • 1. Decreased post-op pain
  • 2. Decreased post-op narcotic use

Secondary Outcome Measures:
  • improved hospital stay satisfaction

Estimated Enrollment: 100
Study Start Date: February 2006
Study Completion Date: October 2007
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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
Information from the National Library of Medicine

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
United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33606
Sponsors and Collaborators
University of South Florida
Investigators
Study Director: Shelly Holmstrom, MD USF Department OB/Gyn
  More Information

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT00298571     History of Changes
Other Study ID Numbers: 1212
First Submitted: February 28, 2006
First Posted: March 2, 2006
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:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Bupivacaine
Epinephrine
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