Combined Spinal/Epidural (CSE) Saline Duration/Spread

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01062893

Enrollment

Registered

2010-02-04

Start date

2009-08-31

Completion date

2012-09-30

Last updated

2018-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Pain

Keywords

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

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.

Interventions

OTHERSterile 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.

OTHER15 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

12 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Highest Sensory Blockade Level to Pinprick and to Cold	up to 20 minutes	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

Measure	Time frame	Description
Onset of Analgesia	up to 20 minutes	time to VAS\</=3 on a 0-10 scale with 0=no pain up to 10= worst pain imaginable
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	occurrence of common side effects of spinal/epidural administration
Number of Participants Who Had Occurrence of Maternal Hypotension	length of labor, up to 24 hours	—
Duration of Analgesia (Time to Request Additional Analgesia)	up 120 minutes	time of CSE to time request of additional supplement analgesia in minutes
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	—
Occurrence of Use of Vasopressors	length of labor, up to 24 hours	—

Countries

United States

Participant flow

Participants by arm

Arm	Count
0 Mls Saline Injected NO SALINE INJECTED 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.	27
15 Mls Saline 15ML SALINE ADMINISTERED EPIDURALLY 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.	28
Total	55

Baseline characteristics

Characteristic	0 Mls Saline Injected	15 Mls Saline	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	27 Participants	28 Participants	55 Participants
Region of Enrollment United States	27 participants	28 participants	55 participants
Sex: Female, Male Female	27 Participants	28 Participants	55 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 27	0 / 28
other Total, other adverse events	0 / 27	0 / 28
serious Total, serious adverse events	0 / 27	0 / 28

Outcome results

Primary

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)

Time frame: up to 20 minutes

Arm	Measure	Value (MEAN)	Dispersion
0 Mls Saline Injected	Highest Sensory Blockade Level to Pinprick and to Cold	10.1 units on a scale	Standard Deviation 2.9
15 Mls Saline	Highest Sensory Blockade Level to Pinprick and to Cold	11.6 units on a scale	Standard Deviation 1.9

Secondary

Duration of Analgesia (Time to Request Additional Analgesia)

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

Time frame: up 120 minutes

Arm	Measure	Value (MEAN)	Dispersion
0 Mls Saline Injected	Duration of Analgesia (Time to Request Additional Analgesia)	57.2 minutes	Standard Deviation 33.9
15 Mls Saline	Duration of Analgesia (Time to Request Additional Analgesia)	77.3 minutes	Standard Deviation 30

Secondary