Comparison of Loss of Resistance Techniques

Phase 2

Completed

• Conditions: Pain Relief
• Interventions: Procedure: Saline; Procedure: Air

• Registration Number: NCT00638274
• Lead Sponsor: Wake Forest University Health Sciences

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.

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.

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2008-03-12
• Study First Submitted QC: 2008-03-12
• Study First Posted: 2008-03-19
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Results First Submitted: 2018-09-05
• Status Verified: 2018-10
• Results First Submitted QC: 2018-10-11
• Last Update Submitted: 2018-10-11
• Results First Posted: 2018-11-09
• Last Update Posted: 2018-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 356

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	Saline	Saline 3 ml used to identify epidural space
Air	Air	Air 3 ml used to identify epidural space

Primary Outcome Measures

Name	Time	Method
Success of Spinal Labor Analgesia From Combined Spinal Epidural	24 hours	Number of participants that had successful spinal labor analgesia in each group.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Failed Epidural Catheters	24 hours	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.

Trial Locations

Locations (1)

Forsyth Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States