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Cesarean Postoperative Pain Satisfaction

This study has been completed.
Sponsor:
Information provided by:
Saint Elizabeth Regional Medical Center
ClinicalTrials.gov Identifier:
NCT00922142
First received: June 16, 2009
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

Hypothesis:

There is no significant difference in Cesarean patients' perceptions of overall pain management satisfaction between methods used for postoperative pain management.


Condition
Cesarean

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Cesarean Postoperative Pain Satisfaction With Intravenous Patient-Controlled Analgesia Intravenous, Oral, or Epidural Method

Further study details as provided by Saint Elizabeth Regional Medical Center:

Biospecimen Retention:   Samples Without DNA

no biospecimens to be retained


Enrollment: 120
Study Start Date: June 2009
Study Completion Date: December 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Detailed Description:

There is a significant difference between Cesarean patients' perceptions of advantages and disadvantages of three postoperative pain management methods identified by obstetrical patients.

Participants will be introduced to study by anesthesia personnel in labor and delivery. The subject will be informed of the desire for their input on their perceived satisfaction with their chosen method for post-operative pain management and will be asked to participate in an anonymous survey by their second day after surgery. They will be informed that this is voluntary. Method of post-operative medication administration will be determined by attending physician to be either: epidural, IVPCA, or oral medication. Methods will be initiated in recovery room or the operative suite.

Subjects will be identified on a postpartum admission log and a screening log will be created for study purposes.

Informed Consents will be obtained. The screening log entries will be numbered corresponding to a numbered survey. The screening log will contain demographic and other patient identifiers including age, ethnicity, parity, presence of labor prior to cesarean, admission status of baby, cost associated with method and presence of rescue drugs and costs of rescue drugs and method services. Refusal information, exclusion criteria, and time/date of survey completion will also be recorded. This log will be maintained under lock and key.

  Eligibility

Ages Eligible for Study:   14 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

post-operative cesarean patients

Criteria

Inclusion Criteria:

  • English speaking post-operative cesarean patients

Exclusion Criteria:

  • Cesarean patients with know fetal demise
  • General/Local Anesthetic Method for Cesarean
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00922142

Locations
United States, Nebraska
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, United States, 68510
Sponsors and Collaborators
Saint Elizabeth Regional Medical Center
Investigators
Principal Investigator: Deb Chambers, RN Saint Elizabeth Regional Medical Center
  More Information

No publications provided

Responsible Party: Debbie Cahmber/Director Perinatal Nursing, Saint Elizabeth Regional Medical Center
ClinicalTrials.gov Identifier: NCT00922142     History of Changes
Other Study ID Numbers: 608-028
Study First Received: June 16, 2009
Last Updated: July 19, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014