CesareanNCT00922142
Cesarean Postoperative Pain Satisfaction
An observational study of Cesarean, run by Saint Elizabeth Regional Medical Center at 1 site in United States.
Trial summary
Hypothesis: There is no significant difference in Cesarean patients' perceptions of overall pain management satisfaction between methods used for postoperative pain management. Read more about this study
- Who is it for?
- Ages 14 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: post-operative cesarean patients
Who may be able to join
- English speaking post-operative cesarean patients
Who cannot join
- Cesarean patients with know fetal demise
- General/Local Anesthetic Method for Cesarean
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, 68510
About this study
Official title: Cesarean Postoperative Pain Satisfaction With Intravenous Patient-Controlled Analgesia Intravenous, Oral, or Epidural Method
Hypothesis:
There is no significant difference in Cesarean patients' perceptions of overall pain management satisfaction between methods used for postoperative pain management.
Read the 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.
- Conditions
- Cesarean
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionAug 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CesareanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Elizabeth Regional Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Deb Chambers, RN, Principal investigator, Saint Elizabeth Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922142
- Sponsor's protocol ID
- 608-028
- Status last verified
- Jul 2011
- First submitted
- 16 Jun 2009
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cesarean Postoperative Pain Satisfaction With Intravenous Patient-Controlled Analgesia Intravenous, Oral, or Epidural Method
- ClinicalTrials.gov ID
- NCT00922142
- Acronym / sponsor ID
- 608-028
- Conditions
- Cesarean
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Saint Elizabeth Regional Medical CenterUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 17 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis:
There is no significant difference in Cesarean patients' perceptions of overall pain management satisfaction between methods used for postoperative pain management.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- post-operative cesarean patients
Key inclusion criteria (1 listed)
- English speaking post-operative cesarean patients
Key exclusion criteria (2 listed)
- Cesarean patients with know fetal demise
- General/Local Anesthetic Method for Cesarean
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deb Chambers, RN principal investigator
Saint Elizabeth Regional Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean, run by Saint Elizabeth Regional Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2011.