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Combined Spinal/Epidural (CSE) Saline Duration/Spread

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Peter H. Pan, M.D., MSEE, Wake Forest University
ClinicalTrials.gov Identifier:
NCT01062893
First received: February 1, 2010
Last updated: March 5, 2013
Last verified: March 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Wake Forest University:

Primary Outcome Measures:
  • Highest sensory blockade level to pinprick and to cold [ Time Frame: <20 minutes ] [ Designated as safety issue: No ]
    onset of analgesia to recession of analgesia


Secondary Outcome Measures:
  • time to onset of analgesia [ Time Frame: <20 minutes ] [ Designated as safety issue: No ]
    CSE dose until pain is <3

  • Duration of analgesia (time to request additional analgesia) [ Time Frame: approximately 1-2 hours ] [ Designated as safety issue: No ]
    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
Genders 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
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
Investigators
Principal Investigator: Peter H Pan, MD, MSEE Wake Forest University
  More Information

No publications provided

Responsible Party: Dr. Peter H. Pan, M.D., MSEE, Professor of Anesthesiology, Wake Forest University
ClinicalTrials.gov Identifier: NCT01062893     History of Changes
Other Study ID Numbers: IRB 9631
Study First Received: February 1, 2010
Last Updated: March 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest University:
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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013