Combined Spinal/Epidural (CSE) Saline Duration/Spread

Study Overview
=================
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.

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

Conditions
-----------------
Labor Pain

Intervention / Treatment
-----------------
* Other: Sterile normal saline 0 mls
* Other: 15 mls sterile normal saline


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 0 mls saline injected<br>NO SALINE INJECTED | Other: Sterile normal saline 0 mls<br>* 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.<br>|
| Active Comparator: 15 mls saline<br>15ML SALINE ADMINISTERED EPIDURALLY | Other: 15 mls sterile normal saline<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Analgesia (Time to Request Additional Analgesia) | time of CSE to time request of additional supplement analgesia in minutes | up 120 minutes | 
| Onset of Analgesia | time to VAS</=3 on a 0-10 scale with 0=no pain up to 10= worst pain imaginable | up to 20 minutes | 
| Time to Highest Sensory Block |  | up to 20 minutes | 
| 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 | 
| Number of Participants Who Had Occurrence of Maternal Hypotension |  | length of labor, up to 24 hours | 
| Occurrence of Use of Vasopressors |  | length of labor, up to 24 hours | 
| Number of Participants Who Had Occurrence of Itching |  | length of labor, up to 24 hours | 
| 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 | 
| Time for Regression of Motor Blockade |  | up to 20 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
labor pain treatment, duration analgesia, Analgesic duration with normal saline injection., Analgesic duration without normal saline injection