NCT01062893

Combined Spinal/Epidural (CSE) Saline Duration/Spread

Effect of Epidural Saline on Duration and Spread of Subsequent Spinal Analgesia/Anesthesia Using a CSE Technique

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

An attempt is being made to see if by injecting a set volume of sterile saline into the epidural space during the treatment of labor pain with a combined spinal/epidural (CSE) increases the amount of pain relief obtained and makes the labor analgesia lasts longer. Subjects are in the study from the time their CSE is placed until they request additional pain medication from the spinal dose of numbing medicine wearing off.

Conditions

• Labor Pain

Interventions

Type	Name	Description
OTHER	Sterile normal saline 0 mls	at time of epidural needle placement there will not be any saline injected into the epidural space prior to placement of the spinal needle to administer the CSE dose of standard analgesic medications. Instead a pause will be done as by the investigator to maintain blind for the assessor.
OTHER	15 mls sterile normal saline	After the epidural needle is placed, 15 mls of sterile normal saline will be injected into the epidural space, then the spinal needle will be placed to administer the CSE dose of standard analgesic medications.

Timeline

• Start date: 2009-08-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2010-02-04
• Last updated: 2018-10-16
• Results posted: 2018-10-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study