Combined Spinal/Epidural (CSE) Saline Duration/Spread

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01062893
• Other study ID #: IRB00009631
• Status: Terminated
• Phase: Phase 2
• Start date: August 2009
• Est. completion date: September 2012

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 82
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• age greater than 12 years of age

• ASA status 1 or 2

• cervical dilation < 6cm

Exclusion Criteria:

• ASA assigned 3 or 4

• advanced labor (> 6cm cervical dilated)

• distorted epidural anatomy

Related Conditions & MeSH terms

• Labor Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Forsyth Medical Center-Sara Lee Center for Women's Health	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	Highest Sensory Blockade Level to Pinprick and to Cold	Onset of analgesia to recession of analgesia. Highest spread of analgesia (highest sensory level) to cold temp and pinprick, with level defined from T1 to L5, where T1 is highest =level 17 and L5 is lowest =Level 1)	up to 20 minutes
Secondary	Duration of Analgesia (Time to Request Additional Analgesia)	time of CSE to time request of additional supplement analgesia in minutes	up 120 minutes
Secondary	Onset of Analgesia	time to VAS	up to 20 minutes
Secondary	Time to Highest Sensory Block		up to 20 minutes
Secondary	Number of Participants Who Had Occurrence of Fetal Bradycardia	occurrence of common side effects of spinal/epidural administration	length of labor, up to 24 hours
Secondary	Number of Participants Who Had Occurrence of Maternal Hypotension		length of labor, up to 24 hours
Secondary	Occurrence of Use of Vasopressors		length of labor, up to 24 hours
Secondary	Number of Participants Who Had Occurrence of Itching		length of labor, up to 24 hours
Secondary	Number of Participants Who Had Occurrence of Post Dural Puncture Headache		length of labor, up to 24 hours
Secondary	Time for 2 Dermatome Level Regression of Sensory Block		up to 20 minutes
Secondary	Time for Regression of Motor Blockade		up to 20 minutes