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:

Drug Information available for: Epinephrine Bupivacaine

U.S. FDA Resources

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

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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

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