Combined Spinal/Epidural (CSE) Saline Duration/Spread

NCT01062893 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: IRB00009631
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain

Keywords

labor pain treatment; duration analgesia; Analgesic duration with normal saline injection.; Analgesic duration without normal saline injection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Duration of Analgesia (Time to Request Additional Analgesia)

  up 120 minutes

• Onset of Analgesia

  up to 20 minutes

• 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

Study Arms (2)

0 mls saline injected

PLACEBO COMPARATOR

NO SALINE INJECTED

Other: Sterile normal saline 0 mls

15 mls saline

ACTIVE COMPARATOR

15ML SALINE ADMINISTERED EPIDURALLY

Other: 15 mls sterile normal saline

Interventions

Sterile normal saline 0 mls OTHER

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.

0 mls saline injected

15 mls sterile normal saline OTHER

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.

15 mls saline

Eligibility Criteria

• Age: 12 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• age greater than 12 years of age
• ASA status 1 or 2
• cervical dilation \< 6cm

You may not qualify if:

• ASA assigned 3 or 4
• advanced labor (\> 6cm cervical dilated)
• distorted epidural anatomy

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Forsyth Medical Center-Sara Lee Center for Women's Health

Winston-Salem, North Carolina, 27103, United States

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Peter H. Pan, MD
• Organization: Wake Forest University School of Medicine

ppan@wakehealth.edu

336-718-8278

Study Officials

• Peter H Pan, MD, MSEE

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2010
• First Posted: February 4, 2010
• Study Start: August 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 16, 2018
• Results First Posted: October 16, 2018

Record last verified: 2018-10

Locations

US (1)