Pain
Conditions
Keywords
Combined spinal epidural duration, labor pain
Brief summary
The hypothesis is that a combined spinal-epidural drug at refrigerated temperature will have a shorter period of pain relief than that maintained at room temperature. The temperature of the dose of medication will be measure with an infrared thermometer immediately prior (within 5 minutes) to administration.
Detailed description
Subjects will receive a combined spinal epidural medication as per standard of care to treat their labor pain; however, they will be randomized to receive either a dose maintained at room temperature (60-75 degrees F) or one maintained in a refrigerator (\ \<43 degrees F). Duration of action will be done by assessments of pain, vital signs, nausea, itching, bromage and fetal heart rate every 15 minutes until the subject requests additional pain medication to treat their labor pain.
Interventions
Combined Spinal Epidural
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* \>/= 18 years of age not allergic to medications used to treat labor pain \</= 6cm cervical dilation visual pain score \>/=3
Exclusion criteria
* \<18 years of age \> 6 cm cervical dilation non-English speaking subjects
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesia Onset-5 Minutes Post Injection | from time of CSE administration | — |
| Analgesia Onset-10 Minutes Post Injection | up to 3 hours | — |
| Analgesia Onset-15 Minutes Post Injection | up to 3 hours | — |
| Pruritus | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Room Temperature room temperature combined spinal epidural dose (60-75 degrees F)
combined spinal epidural: Combined Spinal Epidural | 27 |
| Refrigerated Temperature refrigerated temperature combined spinal epidural dose (\
\<43 degrees F)
combined spinal epidural: Combined Spinal Epidural | 26 |
| Total | 53 |
Baseline characteristics
| Characteristic | Room Temperature | Refrigerated Temperature | 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 | 26 Participants | 53 Participants |
| Region of Enrollment United States | 27 participants | 26 participants | 53 participants |
| Sex: Female, Male Female | 27 Participants | 26 Participants | 53 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 / 26 |
| other Total, other adverse events | 0 / 27 | 0 / 26 |
| serious Total, serious adverse events | 0 / 27 | 0 / 26 |
Outcome results
Primary
Time
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.
Time frame: up to 3 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Room Temperature | Time | 74 minutes | Standard Deviation 29 |
| Refrigerated Temperature | Time | 81 minutes | Standard Deviation 32 |
Secondary
Analgesia Onset-10 Minutes Post Injection
Time frame: up to 3 hours
Population: number of subjects who achieved a VAS pain score of \</= 3 at 10 minutes after CSE injection
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Room Temperature | Analgesia Onset-10 Minutes Post Injection | 25 Participants |
| Refrigerated Temperature | Analgesia Onset-10 Minutes Post Injection | 19 Participants |
Secondary
Analgesia Onset-15 Minutes Post Injection
Time frame: up to 3 hours
Population: number of subjects who achieved a VAS pain score of \</= 3 at 15 minutes after injection
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Room Temperature | Analgesia Onset-15 Minutes Post Injection | 25 Participants |
| Refrigerated Temperature | Analgesia Onset-15 Minutes Post Injection | 24 Participants |
Secondary
Analgesia Onset-5 Minutes Post Injection
Time frame: from time of CSE administration
Population: number of subjects who achieved a VAS pain score of \</=3 at 5 minutes after CSE injection
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Room Temperature | Analgesia Onset-5 Minutes Post Injection | 24 Participants |
| Refrigerated Temperature | Analgesia Onset-5 Minutes Post Injection | 14 Participants |
Secondary
Pruritus
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)
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Room Temperature | Pruritus | 2 units on a scale | Standard Deviation 1 |
| Refrigerated Temperature | Pruritus | 1 units on a scale | Standard Deviation 2 |