Comparison of Loss of Resistance Techniques
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pain Relief |
Procedure: Air Procedure: Saline |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) |
| Official Title: | Comparison of Loss of Resistance Technique With Air Versus Saline to Identify Epidural Space for Combined Spinal Epidural Labor Analgesia |
- 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 ]
| Enrollment: | 350 |
| Study Start Date: | July 2005 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Air 3 ml used to identify epidural space
|
Procedure: Air
3 mls used for identifying epidural space
|
|
Active Comparator: 2
Saline 3 ml used to identify epidural space
|
Procedure: Saline
3 mls of saline used to identify epidural space
|
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Pregnant females weighing less than or equal to 250 lbs
- Request for neuraxial labor analgesia
Exclusion Criteria:
- ASA physical status greater than II
Contacts and Locations| United States, North Carolina | |
| Forsyth Medical Center | |
| Winston-Salem, North Carolina, United States, 27103 | |
| Principal Investigator: | Peter H. Pan, MSEE, MD | Wake Forest University |
More Information
No publications provided
| Responsible Party: | Peter H. Pan, MSEE, MD, Wake Forest University Health Sciences |
| ClinicalTrials.gov Identifier: | NCT00638274 History of Changes |
| Other Study ID Numbers: | Air versus Saline |
| Study First Received: | March 12, 2008 |
| Last Updated: | February 26, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Wake Forest University:
|
Quality of pain relief with 2 different methods of identifying epidural space |
ClinicalTrials.gov processed this record on June 17, 2013