Trial Outcomes & Findings for Outcomes of Neuraxial Anesthetic Technique on the Trial of Labor After Cesarean (TOLAC) (NCT NCT02105558)
NCT ID: NCT02105558
Last Updated: 2018-07-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
46 participants
Primary outcome timeframe
at the time of delivery
Results posted on
2018-07-19
Participant Flow
46 were enrolled, but only 43 started. Of the 3 who did not start: 1 gave birth before the block placement; 2 were disenrolled, but the reason was not recorded.
Participant milestones
| Measure |
Epidural Anesthesia
An epidural involves injecting pain-blocking medication into a space between the vertebrae and the spinal fluid; it usually takes about 15 minutes to work.Epidurals will be placed in a sterile fashion using a 17g Tuohy needle to locate the epidural space via loss-of-resistance to saline at the lumbar vertebral level. 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine will then be used for test dose to exclude intrathecal or intravenous placement of the catheter. Epidural solution composed of 5ml of 0.2% ropivacaine and another 5 ml of 0.2% ropivacaine will then be administered.
|
Combined Spinal and Epidural (CSE) Anesthesia
A spinal is an injection directly into the spinal fluid; it is given in addition to the epidural technique and takes effect in five minutes.
The epidural space will be located with a 17g Tuohy needle and dural puncture performed with 25g Pencan needle via needle-through-needle technique. Spinal injection of 2ml 0.2% ropivacaine will then be performed and spinal needle removed. An epidural catheter will then be placed and test dose performed with 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine. Maintenance dose will be via an epidural pump using 0.2% ropivacaine at a rate of 12 ml/hr.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
28
|
|
Overall Study
COMPLETED
|
15
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Actual birth weight was not recorded for one in the Epidural anesthesia group.
Baseline characteristics by cohort
| Measure |
Epidural Anesthesia
n=15 Participants
An epidural involves injecting pain-blocking medication into a space between the vertebrae and the spinal fluid; it usually takes about 15 minutes to work.Epidurals will be placed in a sterile fashion using a 17g Tuohy needle to locate the epidural space via loss-of-resistance to saline at the lumbar vertebral level. 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine will then be used for test dose to exclude intrathecal or intravenous placement of the catheter. Epidural solution composed of 5ml of 0.2% ropivacaine and another 5 ml of 0.2% ropivacaine will then be administered.
|
Combined Spinal and Epidural (CSE) Anesthesia
n=28 Participants
A spinal is an injection directly into the spinal fluid; it is given in addition to the epidural technique and takes effect in five minutes.
The epidural space will be located with a 17g Tuohy needle and dural puncture performed with 25g Pencan needle via needle-through-needle technique. Spinal injection of 2ml 0.2% ropivacaine will then be performed and spinal needle removed. An epidural catheter will then be placed and test dose performed with 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine. Maintenance dose will be via an epidural pump using 0.2% ropivacaine at a rate of 12 ml/hr.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.1 years
STANDARD_DEVIATION 6.1 • n=15 Participants
|
27.6 years
STANDARD_DEVIATION 5.9 • n=28 Participants
|
27.4 years
STANDARD_DEVIATION 5.9 • n=43 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=15 Participants
|
28 Participants
n=28 Participants
|
43 Participants
n=43 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=43 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=15 Participants
|
27 Participants
n=28 Participants
|
40 Participants
n=43 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=15 Participants
|
1 Participants
n=28 Participants
|
3 Participants
n=43 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=43 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=15 Participants
|
28 Participants
n=28 Participants
|
43 Participants
n=43 Participants
|
|
Reason for Previous Cesarean
Breech
|
5 Participants
n=15 Participants
|
4 Participants
n=28 Participants
|
9 Participants
n=43 Participants
|
|
Reason for Previous Cesarean
Hydrocephalus
|
1 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
1 Participants
n=43 Participants
|
|
Reason for Previous Cesarean
Non-reassuring fetal heart tone
|
0 Participants
n=15 Participants
|
4 Participants
n=28 Participants
|
4 Participants
n=43 Participants
|
|
Reason for Previous Cesarean
Preterm premature rupture of the membranes (PPROM)
|
1 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
1 Participants
n=43 Participants
|
|
Reason for Previous Cesarean
Macrosomia
|
0 Participants
n=15 Participants
|
2 Participants
n=28 Participants
|
2 Participants
n=43 Participants
|
|
Reason for Previous Cesarean
Failure to progress
|
3 Participants
n=15 Participants
|
5 Participants
n=28 Participants
|
8 Participants
n=43 Participants
|
|
Reason for Previous Cesarean
Oligohydramnios
|
0 Participants
n=15 Participants
|
2 Participants
n=28 Participants
|
2 Participants
n=43 Participants
|
|
Reason for Previous Cesarean
Congenital fetal heart anomaly
|
0 Participants
n=15 Participants
|
1 Participants
n=28 Participants
|
1 Participants
n=43 Participants
|
|
Reason for Previous Cesarean
Pre-eclampsia
|
0 Participants
n=15 Participants
|
1 Participants
n=28 Participants
|
1 Participants
n=43 Participants
|
|
Reason for Previous Cesarean
Scoliosis, nuchal cord
|
1 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
1 Participants
n=43 Participants
|
|
Reason for Previous Cesarean
Chorioamnionitis
|
0 Participants
n=15 Participants
|
1 Participants
n=28 Participants
|
1 Participants
n=43 Participants
|
|
Reason for Previous Cesarean
Macrosomia, breech
|
0 Participants
n=15 Participants
|
1 Participants
n=28 Participants
|
1 Participants
n=43 Participants
|
|
Reason for Previous Cesarean
Placenta previa
|
0 Participants
n=15 Participants
|
1 Participants
n=28 Participants
|
1 Participants
n=43 Participants
|
|
Reason for Previous Cesarean
Fetal bradycardia
|
0 Participants
n=15 Participants
|
2 Participants
n=28 Participants
|
2 Participants
n=43 Participants
|
|
Reason for Previous Cesarean
Low amniotic fluid
|
0 Participants
n=15 Participants
|
1 Participants
n=28 Participants
|
1 Participants
n=43 Participants
|
|
Reason for Previous Cesarean
Fetal distress
|
1 Participants
n=15 Participants
|
1 Participants
n=28 Participants
|
2 Participants
n=43 Participants
|
|
Reason for Previous Cesarean
Arrest of labor
|
0 Participants
n=15 Participants
|
1 Participants
n=28 Participants
|
1 Participants
n=43 Participants
|
|
Reason for Previous Cesarean
Nuchal cord
|
0 Participants
n=15 Participants
|
1 Participants
n=28 Participants
|
1 Participants
n=43 Participants
|
|
Reason for Previous Cesarean
Malpresentation
|
1 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
1 Participants
n=43 Participants
|
|
Reason for Previous Cesarean
Failed induction
|
1 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
1 Participants
n=43 Participants
|
|
Reason for Previous Cesarean
Gastrochisis
|
1 Participants
n=15 Participants
|
0 Participants
n=28 Participants
|
1 Participants
n=43 Participants
|
|
Number of pregnancies
|
3.3 number of pregnancies
STANDARD_DEVIATION 1.6 • n=15 Participants
|
3.0 number of pregnancies
STANDARD_DEVIATION 0.9 • n=28 Participants
|
3.1 number of pregnancies
STANDARD_DEVIATION 1.3 • n=43 Participants
|
|
Estimated fetal weight
|
3484 grams
STANDARD_DEVIATION 279 • n=15 Participants
|
3264 grams
STANDARD_DEVIATION 400 • n=28 Participants
|
3341 grams
STANDARD_DEVIATION 374 • n=43 Participants
|
|
Actual fetal weight
|
3453 grams
STANDARD_DEVIATION 445 • n=14 Participants • Actual birth weight was not recorded for one in the Epidural anesthesia group.
|
3292 grams
STANDARD_DEVIATION 369 • n=28 Participants • Actual birth weight was not recorded for one in the Epidural anesthesia group.
|
3346 grams
STANDARD_DEVIATION 398 • n=42 Participants • Actual birth weight was not recorded for one in the Epidural anesthesia group.
|
PRIMARY outcome
Timeframe: at the time of deliveryOutcome measures
| Measure |
Epidural Anesthesia
n=15 Participants
An epidural involves injecting pain-blocking medication into a space between the vertebrae and the spinal fluid; it usually takes about 15 minutes to work.Epidurals will be placed in a sterile fashion using a 17g Tuohy needle to locate the epidural space via loss-of-resistance to saline at the lumbar vertebral level. 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine will then be used for test dose to exclude intrathecal or intravenous placement of the catheter. Epidural solution composed of 5ml of 0.2% ropivacaine and another 5 ml of 0.2% ropivacaine will then be administered.
|
Combined Spinal and Epidural (CSE) Anesthesia
n=28 Participants
A spinal is an injection directly into the spinal fluid; it is given in addition to the epidural technique and takes effect in five minutes.
The epidural space will be located with a 17g Tuohy needle and dural puncture performed with 25g Pencan needle via needle-through-needle technique. Spinal injection of 2ml 0.2% ropivacaine will then be performed and spinal needle removed. An epidural catheter will then be placed and test dose performed with 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine. Maintenance dose will be via an epidural pump using 0.2% ropivacaine at a rate of 12 ml/hr.
|
|---|---|---|
|
Number of Participants With Vaginal Birth After Cesarean (VBAC)
|
12 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: baselinePain score was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of pain. Pain scores less than 3 are considered to indicate successful analgesia.
Outcome measures
| Measure |
Epidural Anesthesia
n=15 Participants
An epidural involves injecting pain-blocking medication into a space between the vertebrae and the spinal fluid; it usually takes about 15 minutes to work.Epidurals will be placed in a sterile fashion using a 17g Tuohy needle to locate the epidural space via loss-of-resistance to saline at the lumbar vertebral level. 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine will then be used for test dose to exclude intrathecal or intravenous placement of the catheter. Epidural solution composed of 5ml of 0.2% ropivacaine and another 5 ml of 0.2% ropivacaine will then be administered.
|
Combined Spinal and Epidural (CSE) Anesthesia
n=28 Participants
A spinal is an injection directly into the spinal fluid; it is given in addition to the epidural technique and takes effect in five minutes.
The epidural space will be located with a 17g Tuohy needle and dural puncture performed with 25g Pencan needle via needle-through-needle technique. Spinal injection of 2ml 0.2% ropivacaine will then be performed and spinal needle removed. An epidural catheter will then be placed and test dose performed with 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine. Maintenance dose will be via an epidural pump using 0.2% ropivacaine at a rate of 12 ml/hr.
|
|---|---|---|
|
Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)
|
7.53 units on a scale
Standard Deviation 2.64
|
8.20 units on a scale
Standard Deviation 1.89
|
SECONDARY outcome
Timeframe: 15 minutes after regional anesthesiaPain score was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of pain. Pain scores less than 3 are considered to indicate successful analgesia.
Outcome measures
| Measure |
Epidural Anesthesia
n=15 Participants
An epidural involves injecting pain-blocking medication into a space between the vertebrae and the spinal fluid; it usually takes about 15 minutes to work.Epidurals will be placed in a sterile fashion using a 17g Tuohy needle to locate the epidural space via loss-of-resistance to saline at the lumbar vertebral level. 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine will then be used for test dose to exclude intrathecal or intravenous placement of the catheter. Epidural solution composed of 5ml of 0.2% ropivacaine and another 5 ml of 0.2% ropivacaine will then be administered.
|
Combined Spinal and Epidural (CSE) Anesthesia
n=28 Participants
A spinal is an injection directly into the spinal fluid; it is given in addition to the epidural technique and takes effect in five minutes.
The epidural space will be located with a 17g Tuohy needle and dural puncture performed with 25g Pencan needle via needle-through-needle technique. Spinal injection of 2ml 0.2% ropivacaine will then be performed and spinal needle removed. An epidural catheter will then be placed and test dose performed with 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine. Maintenance dose will be via an epidural pump using 0.2% ropivacaine at a rate of 12 ml/hr.
|
|---|---|---|
|
Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)
|
2.80 units on a scale
Standard Deviation 2.08
|
2.13 units on a scale
Standard Deviation 2.30
|
SECONDARY outcome
Timeframe: 30 minutes after regional anesthesiaPain score was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of pain. Pain scores less than 3 are considered to indicate successful analgesia.
Outcome measures
| Measure |
Epidural Anesthesia
n=15 Participants
An epidural involves injecting pain-blocking medication into a space between the vertebrae and the spinal fluid; it usually takes about 15 minutes to work.Epidurals will be placed in a sterile fashion using a 17g Tuohy needle to locate the epidural space via loss-of-resistance to saline at the lumbar vertebral level. 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine will then be used for test dose to exclude intrathecal or intravenous placement of the catheter. Epidural solution composed of 5ml of 0.2% ropivacaine and another 5 ml of 0.2% ropivacaine will then be administered.
|
Combined Spinal and Epidural (CSE) Anesthesia
n=28 Participants
A spinal is an injection directly into the spinal fluid; it is given in addition to the epidural technique and takes effect in five minutes.
The epidural space will be located with a 17g Tuohy needle and dural puncture performed with 25g Pencan needle via needle-through-needle technique. Spinal injection of 2ml 0.2% ropivacaine will then be performed and spinal needle removed. An epidural catheter will then be placed and test dose performed with 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine. Maintenance dose will be via an epidural pump using 0.2% ropivacaine at a rate of 12 ml/hr.
|
|---|---|---|
|
Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)
|
2.37 units on a scale
Standard Deviation 2.33
|
1.77 units on a scale
Standard Deviation 2.05
|
SECONDARY outcome
Timeframe: 60 minutes after regional anesthesiaPopulation: Data for 1 participant in the epidural arm were not recorded.
Pain score was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of pain. Pain scores less than 3 are considered to indicate successful analgesia.
Outcome measures
| Measure |
Epidural Anesthesia
n=14 Participants
An epidural involves injecting pain-blocking medication into a space between the vertebrae and the spinal fluid; it usually takes about 15 minutes to work.Epidurals will be placed in a sterile fashion using a 17g Tuohy needle to locate the epidural space via loss-of-resistance to saline at the lumbar vertebral level. 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine will then be used for test dose to exclude intrathecal or intravenous placement of the catheter. Epidural solution composed of 5ml of 0.2% ropivacaine and another 5 ml of 0.2% ropivacaine will then be administered.
|
Combined Spinal and Epidural (CSE) Anesthesia
n=28 Participants
A spinal is an injection directly into the spinal fluid; it is given in addition to the epidural technique and takes effect in five minutes.
The epidural space will be located with a 17g Tuohy needle and dural puncture performed with 25g Pencan needle via needle-through-needle technique. Spinal injection of 2ml 0.2% ropivacaine will then be performed and spinal needle removed. An epidural catheter will then be placed and test dose performed with 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine. Maintenance dose will be via an epidural pump using 0.2% ropivacaine at a rate of 12 ml/hr.
|
|---|---|---|
|
Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)
|
1.79 units on a scale
Standard Deviation 2.22
|
1.63 units on a scale
Standard Deviation 2.15
|
SECONDARY outcome
Timeframe: 24 hours after regional anesthesiaPopulation: Data for 3 participants in the epidural arm and 8 participants in the CSE arm were not recorded.
Pain score was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of pain. Pain scores less than 3 are considered to indicate successful analgesia.
Outcome measures
| Measure |
Epidural Anesthesia
n=12 Participants
An epidural involves injecting pain-blocking medication into a space between the vertebrae and the spinal fluid; it usually takes about 15 minutes to work.Epidurals will be placed in a sterile fashion using a 17g Tuohy needle to locate the epidural space via loss-of-resistance to saline at the lumbar vertebral level. 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine will then be used for test dose to exclude intrathecal or intravenous placement of the catheter. Epidural solution composed of 5ml of 0.2% ropivacaine and another 5 ml of 0.2% ropivacaine will then be administered.
|
Combined Spinal and Epidural (CSE) Anesthesia
n=20 Participants
A spinal is an injection directly into the spinal fluid; it is given in addition to the epidural technique and takes effect in five minutes.
The epidural space will be located with a 17g Tuohy needle and dural puncture performed with 25g Pencan needle via needle-through-needle technique. Spinal injection of 2ml 0.2% ropivacaine will then be performed and spinal needle removed. An epidural catheter will then be placed and test dose performed with 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine. Maintenance dose will be via an epidural pump using 0.2% ropivacaine at a rate of 12 ml/hr.
|
|---|---|---|
|
Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)
|
3.5 units on a scale
Standard Deviation 2.65
|
2.53 units on a scale
Standard Deviation 2.58
|
SECONDARY outcome
Timeframe: 24 hours after regional anesthesiaPopulation: Data for 3 participants in the epidural arm and 8 participants in the CSE arm were not recorded.
Childbirth experience was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a better childbirth experience.
Outcome measures
| Measure |
Epidural Anesthesia
n=12 Participants
An epidural involves injecting pain-blocking medication into a space between the vertebrae and the spinal fluid; it usually takes about 15 minutes to work.Epidurals will be placed in a sterile fashion using a 17g Tuohy needle to locate the epidural space via loss-of-resistance to saline at the lumbar vertebral level. 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine will then be used for test dose to exclude intrathecal or intravenous placement of the catheter. Epidural solution composed of 5ml of 0.2% ropivacaine and another 5 ml of 0.2% ropivacaine will then be administered.
|
Combined Spinal and Epidural (CSE) Anesthesia
n=20 Participants
A spinal is an injection directly into the spinal fluid; it is given in addition to the epidural technique and takes effect in five minutes.
The epidural space will be located with a 17g Tuohy needle and dural puncture performed with 25g Pencan needle via needle-through-needle technique. Spinal injection of 2ml 0.2% ropivacaine will then be performed and spinal needle removed. An epidural catheter will then be placed and test dose performed with 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine. Maintenance dose will be via an epidural pump using 0.2% ropivacaine at a rate of 12 ml/hr.
|
|---|---|---|
|
Childbirth Experience as Assessed by a Visual Analogue Scale (VAS)
|
8.25 units on a scale
Standard Deviation 2.63
|
9.25 units on a scale
Standard Deviation 1.21
|
SECONDARY outcome
Timeframe: 24 hours after regional anesthesiaPopulation: Data for 3 participants in the epidural arm and 8 participants in the CSE arm were not recorded.
Maternal Satisfaction was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of satisfaction.
Outcome measures
| Measure |
Epidural Anesthesia
n=12 Participants
An epidural involves injecting pain-blocking medication into a space between the vertebrae and the spinal fluid; it usually takes about 15 minutes to work.Epidurals will be placed in a sterile fashion using a 17g Tuohy needle to locate the epidural space via loss-of-resistance to saline at the lumbar vertebral level. 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine will then be used for test dose to exclude intrathecal or intravenous placement of the catheter. Epidural solution composed of 5ml of 0.2% ropivacaine and another 5 ml of 0.2% ropivacaine will then be administered.
|
Combined Spinal and Epidural (CSE) Anesthesia
n=20 Participants
A spinal is an injection directly into the spinal fluid; it is given in addition to the epidural technique and takes effect in five minutes.
The epidural space will be located with a 17g Tuohy needle and dural puncture performed with 25g Pencan needle via needle-through-needle technique. Spinal injection of 2ml 0.2% ropivacaine will then be performed and spinal needle removed. An epidural catheter will then be placed and test dose performed with 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine. Maintenance dose will be via an epidural pump using 0.2% ropivacaine at a rate of 12 ml/hr.
|
|---|---|---|
|
Maternal Satisfaction as Assessed by a Visual Analogue Scale (VAS)
|
8.42 units on a scale
Standard Deviation 2.28
|
9.25 units on a scale
Standard Deviation 1.59
|
SECONDARY outcome
Timeframe: 1 minute after birthApgar score is a method to quickly summarize the health of newborn children. The Apgar scale is determined by evaluating the newborn baby on five simple criteria \[Appearance (skin color), Pulse (heart rate), Grimace (reflex irritability), Activity (muscle tone), and Respiration\]. Each crtieria is rated on a scale from 0 to 2, then summing up the five values thus obtained. The resulting Apgar total score ranges from zero to 10. Scores of 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.
Outcome measures
| Measure |
Epidural Anesthesia
n=15 Participants
An epidural involves injecting pain-blocking medication into a space between the vertebrae and the spinal fluid; it usually takes about 15 minutes to work.Epidurals will be placed in a sterile fashion using a 17g Tuohy needle to locate the epidural space via loss-of-resistance to saline at the lumbar vertebral level. 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine will then be used for test dose to exclude intrathecal or intravenous placement of the catheter. Epidural solution composed of 5ml of 0.2% ropivacaine and another 5 ml of 0.2% ropivacaine will then be administered.
|
Combined Spinal and Epidural (CSE) Anesthesia
n=28 Participants
A spinal is an injection directly into the spinal fluid; it is given in addition to the epidural technique and takes effect in five minutes.
The epidural space will be located with a 17g Tuohy needle and dural puncture performed with 25g Pencan needle via needle-through-needle technique. Spinal injection of 2ml 0.2% ropivacaine will then be performed and spinal needle removed. An epidural catheter will then be placed and test dose performed with 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine. Maintenance dose will be via an epidural pump using 0.2% ropivacaine at a rate of 12 ml/hr.
|
|---|---|---|
|
Neonatal Outcome as Assessed by (APGAR) Score
|
8.60 units on a scale
Standard Deviation 0.51
|
8.39 units on a scale
Standard Deviation 0.69
|
SECONDARY outcome
Timeframe: 5 minutes after birthApgar score is a method to quickly summarize the health of newborn children. The Apgar scale is determined by evaluating the newborn baby on five simple criteria \[Appearance (skin color), Pulse (heart rate), Grimace (reflex irritability), Activity (muscle tone), and Respiration\]. Each crtieria is rated on a scale from 0 to 2, then summing up the five values thus obtained. The resulting Apgar total score ranges from zero to 10. Scores of 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.
Outcome measures
| Measure |
Epidural Anesthesia
n=15 Participants
An epidural involves injecting pain-blocking medication into a space between the vertebrae and the spinal fluid; it usually takes about 15 minutes to work.Epidurals will be placed in a sterile fashion using a 17g Tuohy needle to locate the epidural space via loss-of-resistance to saline at the lumbar vertebral level. 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine will then be used for test dose to exclude intrathecal or intravenous placement of the catheter. Epidural solution composed of 5ml of 0.2% ropivacaine and another 5 ml of 0.2% ropivacaine will then be administered.
|
Combined Spinal and Epidural (CSE) Anesthesia
n=28 Participants
A spinal is an injection directly into the spinal fluid; it is given in addition to the epidural technique and takes effect in five minutes.
The epidural space will be located with a 17g Tuohy needle and dural puncture performed with 25g Pencan needle via needle-through-needle technique. Spinal injection of 2ml 0.2% ropivacaine will then be performed and spinal needle removed. An epidural catheter will then be placed and test dose performed with 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine. Maintenance dose will be via an epidural pump using 0.2% ropivacaine at a rate of 12 ml/hr.
|
|---|---|---|
|
Neonatal Outcome as Assessed by (APGAR) Score
|
8.93 units on a scale
Standard Deviation 0.26
|
9.04 units on a scale
Standard Deviation 0.19
|
SECONDARY outcome
Timeframe: from regional anesthesia to delivery (about 86 - 1205 minutes)Population: For 2 participants in the CSE group, delivery time was not recorded and so the time from regional anesthesia to delivery could not be determined.
Outcome measures
| Measure |
Epidural Anesthesia
n=15 Participants
An epidural involves injecting pain-blocking medication into a space between the vertebrae and the spinal fluid; it usually takes about 15 minutes to work.Epidurals will be placed in a sterile fashion using a 17g Tuohy needle to locate the epidural space via loss-of-resistance to saline at the lumbar vertebral level. 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine will then be used for test dose to exclude intrathecal or intravenous placement of the catheter. Epidural solution composed of 5ml of 0.2% ropivacaine and another 5 ml of 0.2% ropivacaine will then be administered.
|
Combined Spinal and Epidural (CSE) Anesthesia
n=26 Participants
A spinal is an injection directly into the spinal fluid; it is given in addition to the epidural technique and takes effect in five minutes.
The epidural space will be located with a 17g Tuohy needle and dural puncture performed with 25g Pencan needle via needle-through-needle technique. Spinal injection of 2ml 0.2% ropivacaine will then be performed and spinal needle removed. An epidural catheter will then be placed and test dose performed with 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine. Maintenance dose will be via an epidural pump using 0.2% ropivacaine at a rate of 12 ml/hr.
|
|---|---|---|
|
Time From Regional Anesthesia to Delivery
|
415.7 minutes
Standard Deviation 208.2
|
454.5 minutes
Standard Deviation 279.1
|
SECONDARY outcome
Timeframe: from the second stage of labor to delivery (about 6 to 174 minutes)Population: Because 2 in the epidural arm and 6 in the CSE arm never dilated to 10cms and were c-sectioned, it was not possible to obtain this value for these 8 participants. For 1 in the epidural arm and 1 in the CSE arm, delivery time was not recorded and so the time from the second stage of labor to delivery could not be determined for these 2 participants.
The second stage of delivery begins after the cervix has dilated to 10 centimeters (cm).
Outcome measures
| Measure |
Epidural Anesthesia
n=12 Participants
An epidural involves injecting pain-blocking medication into a space between the vertebrae and the spinal fluid; it usually takes about 15 minutes to work.Epidurals will be placed in a sterile fashion using a 17g Tuohy needle to locate the epidural space via loss-of-resistance to saline at the lumbar vertebral level. 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine will then be used for test dose to exclude intrathecal or intravenous placement of the catheter. Epidural solution composed of 5ml of 0.2% ropivacaine and another 5 ml of 0.2% ropivacaine will then be administered.
|
Combined Spinal and Epidural (CSE) Anesthesia
n=21 Participants
A spinal is an injection directly into the spinal fluid; it is given in addition to the epidural technique and takes effect in five minutes.
The epidural space will be located with a 17g Tuohy needle and dural puncture performed with 25g Pencan needle via needle-through-needle technique. Spinal injection of 2ml 0.2% ropivacaine will then be performed and spinal needle removed. An epidural catheter will then be placed and test dose performed with 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine. Maintenance dose will be via an epidural pump using 0.2% ropivacaine at a rate of 12 ml/hr.
|
|---|---|---|
|
Time From Second Stage of Labor to Delivery
|
71.25 minutes
Standard Deviation 49.93
|
42.57 minutes
Standard Deviation 44.82
|
Adverse Events
Epidural Anesthesia
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Combined Spinal and Epidural (CSE) Anesthesia
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Epidural Anesthesia
n=15 participants at risk
An epidural involves injecting pain-blocking medication into a space between the vertebrae and the spinal fluid; it usually takes about 15 minutes to work.Epidurals will be placed in a sterile fashion using a 17g Tuohy needle to locate the epidural space via loss-of-resistance to saline at the lumbar vertebral level. 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine will then be used for test dose to exclude intrathecal or intravenous placement of the catheter. Epidural solution composed of 5ml of 0.2% ropivacaine and another 5 ml of 0.2% ropivacaine will then be administered.
|
Combined Spinal and Epidural (CSE) Anesthesia
n=28 participants at risk
A spinal is an injection directly into the spinal fluid; it is given in addition to the epidural technique and takes effect in five minutes.
The epidural space will be located with a 17g Tuohy needle and dural puncture performed with 25g Pencan needle via needle-through-needle technique. Spinal injection of 2ml 0.2% ropivacaine will then be performed and spinal needle removed. An epidural catheter will then be placed and test dose performed with 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine. Maintenance dose will be via an epidural pump using 0.2% ropivacaine at a rate of 12 ml/hr.
|
|---|---|---|
|
Cardiac disorders
hypotension
|
6.7%
1/15 • Number of events 1 • 24 hours after regional anesthesia
|
3.6%
1/28 • Number of events 1 • 24 hours after regional anesthesia
|
|
General disorders
nausea
|
20.0%
3/15 • Number of events 3 • 24 hours after regional anesthesia
|
3.6%
1/28 • Number of events 1 • 24 hours after regional anesthesia
|
|
General disorders
vomiting
|
6.7%
1/15 • Number of events 1 • 24 hours after regional anesthesia
|
3.6%
1/28 • Number of events 1 • 24 hours after regional anesthesia
|
|
General disorders
headache
|
6.7%
1/15 • Number of events 1 • 24 hours after regional anesthesia
|
3.6%
1/28 • Number of events 1 • 24 hours after regional anesthesia
|
Additional Information
Madhumani Rupasinghe, MD
The University of Texas Health Science Center at Houston
Phone: (713) 500-6200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place