Trial Outcomes & Findings for Combined Spinal-Epidural Temperature and Duration of Action (NCT NCT02020304)

Results Overview

length of time in minutes the combined spinal epidural dose duration is calculated from the time of administration until the request is made for additional analgesia (\~1.5-3 hours) post dose. The subjects epidural is then dosed as per standard of care.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

58 participants

Primary outcome timeframe

up to 3 hours

Results posted on

2018-09-10

Participant Flow

Participant milestones

Participant milestones
Measure	Room Temperature room temperature combined spinal epidural dose (60-75 degrees F) combined spinal epidural: Combined Spinal Epidural	Refrigerated Temperature refrigerated temperature combined spinal epidural dose (\~\<43 degrees F) combined spinal epidural: Combined Spinal Epidural
Overall Study STARTED	30	28
Overall Study COMPLETED	27	26
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Combined Spinal-Epidural Temperature and Duration of Action

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Room Temperature n=27 Participants room temperature combined spinal epidural dose (60-75 degrees F) combined spinal epidural: Combined Spinal Epidural	Refrigerated Temperature n=26 Participants refrigerated temperature combined spinal epidural dose (\~\<43 degrees F) combined spinal epidural: Combined Spinal Epidural	Total n=53 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	26 Participants n=7 Participants	53 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	26 Participants n=7 Participants	53 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	26 participants n=7 Participants	53 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 3 hours

length of time in minutes the combined spinal epidural dose duration is calculated from the time of administration until the request is made for additional analgesia (\~1.5-3 hours) post dose. The subjects epidural is then dosed as per standard of care.

Outcome measures

Outcome measures
Measure	Room Temperature n=27 Participants room temperature combined spinal epidural dose (60-75 degrees F) combined spinal epidural: Combined Spinal Epidural	Refrigerated Temperature n=26 Participants refrigerated temperature combined spinal epidural dose (\~\<43 degrees F) combined spinal epidural: Combined Spinal Epidural
Time	74 minutes Standard Deviation 29	81 minutes Standard Deviation 32

SECONDARY outcome

Timeframe: from time of CSE administration

Population: number of subjects who achieved a VAS pain score of \</=3 at 5 minutes after CSE injection

Outcome measures

Outcome measures
Measure	Room Temperature n=27 Participants room temperature combined spinal epidural dose (60-75 degrees F) combined spinal epidural: Combined Spinal Epidural	Refrigerated Temperature n=26 Participants refrigerated temperature combined spinal epidural dose (\~\<43 degrees F) combined spinal epidural: Combined Spinal Epidural
Analgesia Onset-5 Minutes Post Injection	24 Participants	14 Participants

SECONDARY outcome

Timeframe: up to 3 hours

Population: number of subjects who achieved a VAS pain score of \</= 3 at 10 minutes after CSE injection

Outcome measures

Outcome measures
Measure	Room Temperature n=27 Participants room temperature combined spinal epidural dose (60-75 degrees F) combined spinal epidural: Combined Spinal Epidural	Refrigerated Temperature n=26 Participants refrigerated temperature combined spinal epidural dose (\~\<43 degrees F) combined spinal epidural: Combined Spinal Epidural
Analgesia Onset-10 Minutes Post Injection	25 Participants	19 Participants

SECONDARY outcome

Timeframe: up to 3 hours

Population: number of subjects who achieved a VAS pain score of \</= 3 at 15 minutes after injection

Outcome measures

Outcome measures
Measure	Room Temperature n=27 Participants room temperature combined spinal epidural dose (60-75 degrees F) combined spinal epidural: Combined Spinal Epidural	Refrigerated Temperature n=26 Participants refrigerated temperature combined spinal epidural dose (\~\<43 degrees F) combined spinal epidural: Combined Spinal Epidural
Analgesia Onset-15 Minutes Post Injection	25 Participants	24 Participants

SECONDARY outcome

Timeframe: 30 minutes

patients reporting pruritis at 30 minutes after CSE injection, self reported and measured on a scale of 0 (no itching at all) up to 10 (itching as bad as can be imagined)

Outcome measures

Outcome measures
Measure	Room Temperature n=27 Participants room temperature combined spinal epidural dose (60-75 degrees F) combined spinal epidural: Combined Spinal Epidural	Refrigerated Temperature n=26 Participants refrigerated temperature combined spinal epidural dose (\~\<43 degrees F) combined spinal epidural: Combined Spinal Epidural
Pruritus	2 units on a scale Standard Deviation 1	1 units on a scale Standard Deviation 2

Adverse Events

Room Temperature

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Refrigerated Temperature

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vernon H Ross MD

Wake Forest School of Medicine

Phone: 336-718-8278

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place