Text Size

Cesarean Delivery and Post-operative Pain Management With Local Anesthesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT00298571
First received: February 28, 2006
Last updated: June 14, 2012
Last verified: February 2006
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section
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
  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

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

No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT00298571     History of Changes
Other Study ID Numbers: 1212
Study First Received: February 28, 2006
Last Updated: June 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
Cesarean Delivery
Post-operative
Pain
Local Anesthetic

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Epinephrine
Epinephryl borate
Bupivacaine
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
 Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents

ClinicalTrials.gov processed this record on May 23, 2013