Combined Spinal/Epidural (CSE) Saline Duration/Spread

Phase 2

Terminated

• Conditions: Labor Pain
• Interventions: Other: 15 mls sterile normal saline; Other: Sterile normal saline 0 mls

• Registration Number: NCT01062893
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2010-02-01
• Study First Submitted QC: 2010-02-03
• Study First Posted: 2010-02-04
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Results First Submitted: 2018-09-10
• Status Verified: 2018-10
• Results First Submitted QC: 2018-10-12
• Last Update Submitted: 2018-10-12
• Results First Posted: 2018-10-16
• Last Update Posted: 2018-10-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
15 mls saline	15 mls sterile normal saline	15ML SALINE ADMINISTERED EPIDURALLY
0 mls saline injected	Sterile normal saline 0 mls	NO SALINE INJECTED

Primary Outcome Measures

Name	Time	Method
Highest Sensory Blockade Level to Pinprick and to Cold	up to 20 minutes	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)

Secondary Outcome Measures

Name	Time	Method
Duration of Analgesia (Time to Request Additional Analgesia)	up 120 minutes	time of CSE to time request of additional supplement analgesia in minutes
Onset of Analgesia	up to 20 minutes	time to VAS\</=3 on a 0-10 scale with 0=no pain up to 10= worst pain imaginable
Occurrence of Use of Vasopressors	length of labor, up to 24 hours
Time to Highest Sensory Block	up to 20 minutes
Number of Participants Who Had Occurrence of Fetal Bradycardia	length of labor, up to 24 hours	occurrence of common side effects of spinal/epidural administration
Number of Participants Who Had Occurrence of Maternal Hypotension	length of labor, up to 24 hours
Number of Participants Who Had Occurrence of Itching	length of labor, up to 24 hours
Time for Regression of Motor Blockade	up to 20 minutes
Number of Participants Who Had Occurrence of Post Dural Puncture Headache	length of labor, up to 24 hours
Time for 2 Dermatome Level Regression of Sensory Block	up to 20 minutes

Trial Locations

Locations (1)

Forsyth Medical Center-Sara Lee Center for Women's Health; 🇺🇸 Winston-Salem, North Carolina, United States