Comparison of Loss of Resistance Techniques

Pain Relief Clinical Trial

Official title:

Comparison of Loss of Resistance Technique With Air Versus Saline to Identify Epidural Space for Combined Spinal Epidural Labor Analgesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00638274
• Other study ID #: Air versus Saline
• Status: Completed
• Phase: Phase 2
• Start date: July 2005
• Est. completion date: May 2008

Study information

• Verified date: October 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pain Relief

Intervention

Procedure:
• Air
3 mls used for identifying epidural space
• Saline
3 mls of saline used to identify epidural space

Locations

Country	Name	City	State
United States	Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of Spinal Labor Analgesia From Combined Spinal Epidural	Number of participants that had successful spinal labor analgesia in each group.	24 hours
Secondary	Number of Participants With Failed Epidural Catheters	Number of Participants with Failed Epidural Catheters and that had to be replaced at any time measured from the time of the catheter is placed until the time of delivery.	24 hours