NCT01062893TerminatedPhase 2
Effect of Epidural Saline on Duration and Spread of Subsequent Spinal Analgesia/Anesthesia Using a CSE Technique
Wake Forest University Health Sciences2 sites in 1 country82 target enrollmentStarted: August 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Enrollment
- 82
- Locations
- 2
- Primary Endpoint
- Highest Sensory Blockade Level to Pinprick and to Cold
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Highest Sensory Blockade Level to Pinprick and to Cold
Time Frame: 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 Outcomes
- Duration of Analgesia (Time to Request Additional Analgesia)(up 120 minutes)
- Onset of Analgesia(up to 20 minutes)
- 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)
- 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)
Investigators
Study Sites (2)
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