Labor Pain
Conditions
Keywords
labor pain, combined spinal epidural labor analgesia, CSE analgesia, labor analgesia
Brief summary
The investigators hypothesis is that spinal tetracaine with fentanyl and epinephrine used for CSE labor analgesia volume will last a significantly longer period of time that that of spinal bupivacaine with fentanyl. After informed consent is obtained for the study, subjects meeting criteria when analgesia is requested will be randomized to receive a combined spinal-epidural containing either tetracaine 2 mg with fentanyl and epinephrine or bupivacaine 2 mg with fentanyl and epinephrine.
Interventions
DRUGTetracaine
Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.
DRUGBupivacaine
Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.
Sponsors
Wake Forest University
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
No
Inclusion criteria
* early labor (\>=2cm but =\<6cm cervical dilation) * at least 12 years of age * have an assigned ASA physical status 1 or 2 * singleton pregnancy
Exclusion criteria
* contraindications to neuraxial anesthesia * with allergies to drugs used in the study * have an assigned ASA status 3 or 4 * advanced labor (\> 6cm cervical dilation) * less than 12 years of age * Patients with the potential for distorted epidural anatomy, such as Harrington rods or prior back surgery, will also be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spinal Analgesic Duration | 1-2 hrs | duration of time in minutes from the time the combined spinal epidural is placed until the participant requests additional analgesia; at that time the epidural was dosed and study participation was complete |
Countries
United States
Participant flow
Recruitment details
Participants were approached after admission to the labor and delivery unit of our hospital about participation in this study
Participants by arm
| Arm | Count |
|---|---|
| Tetracaine 2mg Tetracaine: Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain. | 23 |
| Bupivacaine 2 mg Bupivacaine: Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain. | 23 |
| Total | 46 |
Baseline characteristics
| Characteristic | Total | Bupivacaine 2 mg | Tetracaine 2mg |
|---|---|---|---|
| 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 | 46 Participants | 23 Participants | 23 Participants |
| Race/Ethnicity, Customized african american | 7 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized hispanic | 3 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized other | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized white | 35 Participants | 17 Participants | 18 Participants |
| Region of Enrollment United States | 46 participants | 23 participants | 23 participants |
| Sex: Female, Male Female | 46 Participants | 23 Participants | 23 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 / 23 | 0 / 23 |
| other Total, other adverse events | 0 / 23 | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 |
Outcome results
Primary
Spinal Analgesic Duration
duration of time in minutes from the time the combined spinal epidural is placed until the participant requests additional analgesia; at that time the epidural was dosed and study participation was complete
Time frame: 1-2 hrs
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tetracaine 2mg | Spinal Analgesic Duration | 92.68 minutes | Standard Deviation 46.71 |
| Bupivacaine 2 mg | Spinal Analgesic Duration | 89.61 minutes | Standard Deviation 27.39 |
p-value: >0.05unpaired t-test compared between groups
p-value: >0.05unpaired t-test compared between groups