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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 12, 2008 | ||||
| Last Updated Date | February 26, 2009 | ||||
| Start Date ICMJE | July 2005 | ||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To compare whether air or saline makes a difference in the success and quality of labor pain relief when the combined spinal epidural is used to treat labor pain relief. [ Time Frame: evaluate at delivery for catheter success ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
To compare whether air or saline makes a difference in the success and quality of labor pain relief when the combined spinal epidural is used to treat labor pain relief. [ Time Frame: study end ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00638274 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparison of Loss of Resistance Techniques | ||||
| Official Title ICMJE | Comparison of Loss of Resistance Technique With Air Versus Saline to Identify Epidural Space for Combined Spinal Epidural Labor Analgesia | ||||
| Brief Summary | The purpose of this study is to determine whether there is a difference in success outcome of the combined spinal epidural labor analgesia between air versus saline when used to identify the epidural space. |
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| Detailed Description | When the epidural needle is inserted initially, it is typically connected to a syringe filled with 2-3 ml or air or saline. This is used to help identify the placement of the epidural needle. Both air and saline are commonly used and it is not clear and debatable which is a better method to identify the correct placement of the needle. Some doctors like using air in the syringe because when a drop of clear fluid returned from the smaller spinal needle, it would be clear to indicate the correct space for first dose of medicine since no pre-existing fluid was used. In group Saline, 3 mL of saline will be used. In group Air, 3 mL of air will be used in the syringe during the procedure. The medicine will be administered in the usual manner the doctor has identified the correct location for administration. The amount of pain during labor will be assessed the patient giving a number from 0 to 10 with 0 being no pain and 10 being the worst pain. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Other, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Pain Relief | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 350 | ||||
| Completion Date | May 2008 | ||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00638274 | ||||
| Responsible Party | Peter H. Pan, MSEE, MD, Wake Forest University Health Sciences | ||||
| Study ID Numbers ICMJE | Air versus Saline | ||||
| Study Sponsor ICMJE | Wake Forest University | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Wake Forest University | ||||
| Verification Date | February 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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