Cesarean Postoperative Pain Satisfaction

Cesarean Clinical Trial

Official title:

Cesarean Postoperative Pain Satisfaction With Intravenous Patient-Controlled Analgesia Intravenous, Oral, or Epidural Method

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00922142
• Other study ID #: 608-028
• Status: Completed
• Phase: N/A
• First received: June 16, 2009
• Last updated: July 19, 2011
• Start date: June 2009
• Est. completion date: December 2009

Study information

• Verified date: July 2011
• Source: Saint Elizabeth Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Hypothesis:

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 40 Years

Eligibility

Inclusion Criteria:

• English speaking post-operative cesarean patients

Exclusion Criteria:

• Cesarean patients with know fetal demise

• General/Local Anesthetic Method for Cesarean

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cesarean
• Pain, Postoperative

Locations

Country	Name	City	State
United States	Saint Elizabeth Regional Medical Center	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Saint Elizabeth Regional Medical Center

Country where clinical trial is conducted

United States,