Cesarean Delivery and Post-Operative Pain Management With Local Anesthesia

This study is currently recruiting participants.

Verified by University of South Florida, February 2006

Sponsored by:	University of South Florida
Information provided by:	University of South Florida
ClinicalTrials.gov Identifier:	NCT00298571

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 II Phase III

MedlinePlus related topics: Anesthesia Cesarean Section

Drug Information available for: Epinephrine Epinephrine bitartrate Bupivacaine Bupivacaine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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
Estimated Study Completion Date:	February 2007

Show Detailed Description

Eligibility

Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298571

Contacts

Contact: aaron b deutsch, md	813-785-1210	abdmd2003@hotmail.com
Contact: shelly holmstrom, md		sholmstrom@hsc.usf.edu

Locations

United States, Florida
Tampa General Hospital	Recruiting
tampa, Florida, United States, 33606
Principal Investigator: aaron b deutsch, md

Sponsors and Collaborators

University of South Florida

Investigators

Study Director:

Shelly Holmstrom, MD

USF Department OB/Gyn

More Information

Study ID Numbers:	1212
Study First Received:	February 28, 2006
Last Updated:	February 28, 2006
ClinicalTrials.gov Identifier:	NCT00298571
Health Authority:	United States: Institutional Review Board

Keywords provided by University of South Florida:

Cesarean Delivery
Post-operative
Pain
Local Anesthetic

Study placed in the following topic categories:

Signs and Symptoms
Postoperative Complications
Bupivacaine

Pain
Epinephrine
Pain, Postoperative

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Sympathomimetics
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Anti-Asthmatic Agents
Cardiovascular Agents

Anesthetics, Local
Pharmacologic Actions
Adrenergic Agonists
Pathologic Processes
Mydriatics
Sensory System Agents
Autonomic Agents
Therapeutic Uses
Vasoconstrictor Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009