Combined Spinal/Epidural (CSE) Saline Duration/Spread

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

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 Overview

• Status: Terminated
• Conditions: Labor Pain
• Intervention / Treatment: Other: Sterile normal saline 0 mls; Other: 15 mls sterile normal saline

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Forsyth Medical Center-Sara Lee Center for Women's Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 0 mls saline injected; NO SALINE INJECTED	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.
Active Comparator: 15 mls saline; 15ML SALINE ADMINISTERED EPIDURALLY	Other: 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.

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Peter H Pan, MD, MSEE, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: February 1, 2010
• First Submitted That Met QC Criteria: February 3, 2010
• First Posted (Estimate): February 4, 2010

Study Record Updates

• Last Update Posted (Actual): October 16, 2018
• Last Update Submitted That Met QC Criteria: October 12, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: labor pain treatment; duration analgesia; Analgesic duration with normal saline injection.; Analgesic duration without normal saline injection
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: IRB00009631

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No