Trial Outcomes & Findings for Combined Spinal/Epidural (CSE) Saline Duration/Spread (NCT NCT01062893)

Results Overview

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)

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

82 participants

Primary outcome timeframe

up to 20 minutes

Results posted on

2018-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	41	41
Overall Study COMPLETED	27	28
Overall Study NOT COMPLETED	14	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Combined Spinal/Epidural (CSE) Saline Duration/Spread

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	0 Mls Saline Injected n=27 Participants 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.	15 Mls Saline n=28 Participants 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.	Total n=55 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants	28 Participants n=7 Participants	55 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	28 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants	28 participants n=7 Participants	55 participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	0 Mls Saline Injected n=27 Participants 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.	15 Mls Saline n=28 Participants 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.
Highest Sensory Blockade Level to Pinprick and to Cold	10.1 units on a scale Standard Deviation 2.9	11.6 units on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: up 120 minutes

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

Outcome measures

Outcome measures
Measure	0 Mls Saline Injected n=27 Participants 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.	15 Mls Saline n=28 Participants 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.
Duration of Analgesia (Time to Request Additional Analgesia)	57.2 minutes Standard Deviation 33.9	77.3 minutes Standard Deviation 30.0

SECONDARY outcome

Timeframe: up to 20 minutes

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

Outcome measures

Outcome measures
Measure	0 Mls Saline Injected n=27 Participants 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.	15 Mls Saline n=28 Participants 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.
Onset of Analgesia	7.96 minutes Standard Deviation 5.24	6.07 minutes Standard Deviation 3.15

SECONDARY outcome

Timeframe: up to 20 minutes