Combined Spinal/Epidural (CSE) Saline Duration/Spread
Primary Purpose
Labor Pain
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sterile normal saline 0 mls
15 mls sterile normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Labor Pain focused on measuring labor pain treatment, duration analgesia, Analgesic duration with normal saline injection., Analgesic duration without normal saline injection
Eligibility Criteria
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
Sites / Locations
- Forsyth Medical Center-Sara Lee Center for Women's Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
0 mls saline injected
15 mls saline
Arm Description
NO SALINE INJECTED
15ML SALINE ADMINISTERED EPIDURALLY
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Duration of Analgesia (Time to Request Additional Analgesia)
time of CSE to time request of additional supplement analgesia in minutes
Onset of Analgesia
time to VAS</=3 on a 0-10 scale with 0=no pain up to 10= worst pain imaginable
Time to Highest Sensory Block
Number of Participants Who Had Occurrence of Fetal Bradycardia
occurrence of common side effects of spinal/epidural administration
Number of Participants Who Had Occurrence of Maternal Hypotension
Occurrence of Use of Vasopressors
Number of Participants Who Had Occurrence of Itching
Number of Participants Who Had Occurrence of Post Dural Puncture Headache
Time for 2 Dermatome Level Regression of Sensory Block
Time for Regression of Motor Blockade
Full Information
NCT ID
NCT01062893
First Posted
February 1, 2010
Last Updated
October 12, 2018
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01062893
Brief Title
Combined Spinal/Epidural (CSE) Saline Duration/Spread
Official Title
Effect of Epidural Saline on Duration and Spread of Subsequent Spinal Analgesia/Anesthesia Using a CSE Technique
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
lack of subjects and manpower issues
Study Start Date
August 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
labor pain treatment, duration analgesia, Analgesic duration with normal saline injection., Analgesic duration without normal saline injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0 mls saline injected
Arm Type
Placebo Comparator
Arm Description
NO SALINE INJECTED
Arm Title
15 mls saline
Arm Type
Active Comparator
Arm Description
15ML SALINE ADMINISTERED EPIDURALLY
Intervention Type
Other
Intervention Name(s)
Sterile normal saline 0 mls
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
15 mls sterile normal saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Highest Sensory Blockade Level to Pinprick and to Cold
Description
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)
Time Frame
up to 20 minutes
Secondary Outcome Measure Information:
Title
Duration of Analgesia (Time to Request Additional Analgesia)
Description
time of CSE to time request of additional supplement analgesia in minutes
Time Frame
up 120 minutes
Title
Onset of Analgesia
Description
time to VAS</=3 on a 0-10 scale with 0=no pain up to 10= worst pain imaginable
Time Frame
up to 20 minutes
Title
Time to Highest Sensory Block
Time Frame
up to 20 minutes
Title
Number of Participants Who Had Occurrence of Fetal Bradycardia
Description
occurrence of common side effects of spinal/epidural administration
Time Frame
length of labor, up to 24 hours
Title
Number of Participants Who Had Occurrence of Maternal Hypotension
Time Frame
length of labor, up to 24 hours
Title
Occurrence of Use of Vasopressors
Time Frame
length of labor, up to 24 hours
Title
Number of Participants Who Had Occurrence of Itching
Time Frame
length of labor, up to 24 hours
Title
Number of Participants Who Had Occurrence of Post Dural Puncture Headache
Time Frame
length of labor, up to 24 hours
Title
Time for 2 Dermatome Level Regression of Sensory Block
Time Frame
up to 20 minutes
Title
Time for Regression of Motor Blockade
Time Frame
up to 20 minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter H Pan, MD, MSEE
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Forsyth Medical Center-Sara Lee Center for Women's Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Combined Spinal/Epidural (CSE) Saline Duration/Spread
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