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Combined Spinal/Epidural (CSE) Saline Duration/Spread

Primary Purpose

Labor Pain

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Sterile normal saline 0 mls

15 mls sterile normal saline

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring labor pain treatment, duration analgesia, Analgesic duration with normal saline injection., Analgesic duration without normal saline injection

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

0 mls saline injected

15 mls saline

Arm Description

NO SALINE INJECTED

15ML SALINE ADMINISTERED EPIDURALLY

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Duration of Analgesia (Time to Request Additional Analgesia)

time of CSE to time request of additional supplement analgesia in minutes

Onset of Analgesia

time to VAS</=3 on a 0-10 scale with 0=no pain up to 10= worst pain imaginable

Time to Highest Sensory Block

Number of Participants Who Had Occurrence of Fetal Bradycardia

occurrence of common side effects of spinal/epidural administration

Number of Participants Who Had Occurrence of Maternal Hypotension

Occurrence of Use of Vasopressors

Number of Participants Who Had Occurrence of Itching

Number of Participants Who Had Occurrence of Post Dural Puncture Headache

Time for 2 Dermatome Level Regression of Sensory Block

Time for Regression of Motor Blockade

Full Information

NCT ID

NCT01062893

First Posted

February 1, 2010

Last Updated

October 12, 2018

Sponsor

Wake Forest University Health Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01062893

Brief Title

Combined Spinal/Epidural (CSE) Saline Duration/Spread

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Terminated

Why Stopped

lack of subjects and manpower issues

Study Start Date

August 2009 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Labor Pain

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0 mls saline injected

Arm Type

Placebo Comparator

Arm Description

NO SALINE INJECTED

Arm Title

15 mls saline

Arm Type

Active Comparator

Arm Description

15ML SALINE ADMINISTERED EPIDURALLY

Intervention Type

Other

Intervention Name(s)

Sterile normal saline 0 mls

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

15 mls sterile normal saline

Intervention Description

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.

Primary Outcome Measure Information:

Title

Highest Sensory Blockade Level to Pinprick and to Cold

Description

Time Frame

up to 20 minutes

Secondary Outcome Measure Information:

Title

Duration of Analgesia (Time to Request Additional Analgesia)

Description

time of CSE to time request of additional supplement analgesia in minutes

Time Frame

up 120 minutes

Title

Onset of Analgesia

Description

time to VAS</=3 on a 0-10 scale with 0=no pain up to 10= worst pain imaginable

Time Frame

up to 20 minutes

Title

Time to Highest Sensory Block

Time Frame

up to 20 minutes

Title

Number of Participants Who Had Occurrence of Fetal Bradycardia

Description

occurrence of common side effects of spinal/epidural administration

Time Frame