This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Combined Spinal/Epidural (CSE) Saline Duration/Spread

This study has been terminated.
(lack of subjects and manpower issues)
Sponsor:
Information provided by (Responsible Party):
Dr. Peter H. Pan, M.D., MSEE, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT01062893
First received: February 1, 2010
Last updated: March 27, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention
Labor Pain Other: Sterile normal saline 0 mls Other: 15 mls sterile normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official Title: Effect of Epidural Saline on Duration and Spread of Subsequent Spinal Analgesia/Anesthesia Using a CSE Technique

Further study details as provided by Dr. Peter H. Pan, M.D., MSEE, Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Highest sensory blockade level to pinprick and to cold [ Time Frame: <20 minutes ]
    onset of analgesia to recession of analgesia


Secondary Outcome Measures:
  • Duration of analgesia (time to request additional analgesia) [ Time Frame: approximately 1-2 hours ]
    from pain relief <3 to time analgesia receding


Enrollment: 60
Study Start Date: August 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062893

Locations
United States, North Carolina
Forsyth Medical Center-Sara Lee Center for Women's Health
Winston-Salem, North Carolina, United States, 27103
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: Peter H Pan, MD, MSEE Wake Forest University Health Sciences
  More Information

Responsible Party: Dr. Peter H. Pan, M.D., MSEE, Professor of Anesthesiology, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01062893     History of Changes
Other Study ID Numbers: IRB 9631
Study First Received: February 1, 2010
Last Updated: March 27, 2017

Keywords provided by Dr. Peter H. Pan, M.D., MSEE, Wake Forest University Health Sciences:
labor pain treatment
duration analgesia
Analgesic duration with normal saline injection.
Analgesic duration without normal saline injection

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2017