Analgesics, Analgesics, Opioid, Central Nervous System Depressants, Morphine, Narcotics, Physiological Effect of Drugs
Conditions
Keywords
cesarean delivery, c-section, chloroprocaine, lidocaine, morphine, post-operative pain, post-cesarean analgesia
Brief summary
The purpose of this study is to show that the effect of 3% 2-chloroprocaine prior to epidural morphine administration will be not inferior to the effect of epidural 2% lidocaine with 1:200,000 epinephrine on total opioid use for 24h
Interventions
DRUG2% lidocaine with 1:200,000 epinephrine and epidural morphine
Epidurals will be dosed with 2% lidocaine with 1:200,000 epinephrine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
DRUG3% 2-chloroprocaine and epidural morphine
Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. This is the critical component to bridge the latency period between the offset of 3% 2-chloroprocaine and the peak action of epidural morphine.Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* pregnant patients * live singleton pregnancy
Exclusion criteria
* BMI \>40 * obstructive sleep apnea * drug abuse * chronic pain * chronic opioid use * nonfunctioning epidural
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Amount of Opioid Used | 24 hours after epidural morphine administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Amount of Opioid Used | 12 hours after epidural morphine administration | — |
| Pain as Measured by a 11 Point Verbal Scale | 4,8, 12 and 24 hours after epidural morphine administration | scale ranges form 0-10, higher number indicating more pain |
| Number of Participants Who Had Mild, Moderate or Severe Nausea as Measured by a 3 Point Scale | 4,8, 12 and 24 hours after epidural morphine administration | scale ranges from non,mild and moderate-severe |
| Number of Participants Who Had Mild, Moderate or Severe Pruritis as Measured by a 3 Point Scale | 4,8, 12 and 24 hours after epidural morphine administration | scale ranges from non,mild and moderate-severe |
| Time Until First Opioid Request | Up to 48 hours after epidural morphine administration | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 2 Percent Lidocaine With Epinephrine and Epidural Morphine 2% lidocaine with 1:200,000 epinephrine and epidural morphine: Epidurals will be dosed with 2% lidocaine with 1:200,000 epinephrine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written. | 20 |
| 3 Percent 2-Chloroprocaine and Epidural Morphine 3% 2-chloroprocaine and epidural morphine: Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. This is the critical component to bridge the latency period between the offset of 3% 2-chloroprocaine and the peak action of epidural morphine.Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 2 | 2 |
Baseline characteristics
| Characteristic | 2 Percent Lidocaine With Epinephrine and Epidural Morphine | 3 Percent 2-Chloroprocaine and Epidural Morphine | Total |
|---|---|---|---|
| Age, Continuous | 27.6 years STANDARD_DEVIATION 5.4 | 29.8 years STANDARD_DEVIATION 5.4 | 28.7 years STANDARD_DEVIATION 5.4 |
| Body Mass Index | 32.3 kg/m^2 STANDARD_DEVIATION 4.4 | 32.4 kg/m^2 STANDARD_DEVIATION 4.2 | 32.35 kg/m^2 STANDARD_DEVIATION 4.3 |
| Duration of labor analgesia | 8.5 hours STANDARD_DEVIATION 4.8 | 7.9 hours STANDARD_DEVIATION 5.6 | 8.2 hours STANDARD_DEVIATION 5.21 |
| Gestational age | 38.7 weeks STANDARD_DEVIATION 1.1 | 38.6 weeks STANDARD_DEVIATION 1.1 | 38.65 weeks STANDARD_DEVIATION 1.1 |
| Gravida | 1 pregnancies | 2 pregnancies | 1 pregnancies |
| Height | 159.5 centimeters STANDARD_DEVIATION 6.9 | 163 centimeters STANDARD_DEVIATION 7.5 | 161.25 centimeters STANDARD_DEVIATION 7.2 |
| Number of participants who received a labor analgesia with combined spinal epidural | 3 Participants | 2 Participants | 5 Participants |
| Number of Participants who Smoke | 0 Participants | 0 Participants | 0 Participants |
| Number of Participants with Prior Cesarean Delivery / trial of labor after cesarean | 0 Participants | 3 Participants | 3 Participants |
| Para | 0 completed pregnancies | 0 completed pregnancies | 0 completed pregnancies |
| Race/Ethnicity, Customized African American | 8 Participants | 8 Participants | 16 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Caucasian | 4 Participants | 5 Participants | 9 Participants |
| Race/Ethnicity, Customized Hispanic | 7 Participants | 5 Participants | 12 Participants |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Surgical Complication (uterine artery laceration and postpartum hemorrhage) | 0 Participants | 1 Participants | 1 Participants |
| Surgical duration | 34.5 minutes | 42 minutes | 38.5 minutes |
| Weight | 84.0 kilograms STANDARD_DEVIATION 13.2 | 87.1 kilograms STANDARD_DEVIATION 14.8 | 85.55 kilograms STANDARD_DEVIATION 14.02 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 10 / 20 | 6 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Total Amount of Opioid Used
Time frame: 24 hours after epidural morphine administration
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2 Percent Lidocaine With Epinephrine and Epidural Morphine | Total Amount of Opioid Used | 15 milligrams |
| 3 Percent 2-Chloroprocaine and Epidural Morphine | Total Amount of Opioid Used | 0 milligrams |
Secondary
Number of Participants Who Had Mild, Moderate or Severe Nausea as Measured by a 3 Point Scale
scale ranges from non,mild and moderate-severe
Time frame: 4,8, 12 and 24 hours after epidural morphine administration
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2 Percent Lidocaine With Epinephrine and Epidural Morphine | Number of Participants Who Had Mild, Moderate or Severe Nausea as Measured by a 3 Point Scale | 4 hours | 3 Participants |
| 2 Percent Lidocaine With Epinephrine and Epidural Morphine | Number of Participants Who Had Mild, Moderate or Severe Nausea as Measured by a 3 Point Scale | 8 hours | 1 Participants |
| 2 Percent Lidocaine With Epinephrine and Epidural Morphine | Number of Participants Who Had Mild, Moderate or Severe Nausea as Measured by a 3 Point Scale | 12 hours | 0 Participants |
| 2 Percent Lidocaine With Epinephrine and Epidural Morphine | Number of Participants Who Had Mild, Moderate or Severe Nausea as Measured by a 3 Point Scale | 24 hours | 0 Participants |
| 3 Percent 2-Chloroprocaine and Epidural Morphine | Number of Participants Who Had Mild, Moderate or Severe Nausea as Measured by a 3 Point Scale | 24 hours | 0 Participants |
| 3 Percent 2-Chloroprocaine and Epidural Morphine | Number of Participants Who Had Mild, Moderate or Severe Nausea as Measured by a 3 Point Scale | 4 hours | 1 Participants |
| 3 Percent 2-Chloroprocaine and Epidural Morphine | Number of Participants Who Had Mild, Moderate or Severe Nausea as Measured by a 3 Point Scale | 12 hours | 0 Participants |
| 3 Percent 2-Chloroprocaine and Epidural Morphine | Number of Participants Who Had Mild, Moderate or Severe Nausea as Measured by a 3 Point Scale | 8 hours | 2 Participants |
Secondary
Number of Participants Who Had Mild, Moderate or Severe Pruritis as Measured by a 3 Point Scale
scale ranges from non,mild and moderate-severe
Time frame: 4,8, 12 and 24 hours after epidural morphine administration
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2 Percent Lidocaine With Epinephrine and Epidural Morphine | Number of Participants Who Had Mild, Moderate or Severe Pruritis as Measured by a 3 Point Scale | 4 hours | 7 Participants |
| 2 Percent Lidocaine With Epinephrine and Epidural Morphine | Number of Participants Who Had Mild, Moderate or Severe Pruritis as Measured by a 3 Point Scale | 8 hours | 6 Participants |
| 2 Percent Lidocaine With Epinephrine and Epidural Morphine | Number of Participants Who Had Mild, Moderate or Severe Pruritis as Measured by a 3 Point Scale | 12 hours | 4 Participants |
| 2 Percent Lidocaine With Epinephrine and Epidural Morphine | Number of Participants Who Had Mild, Moderate or Severe Pruritis as Measured by a 3 Point Scale | 24 hours | 2 Participants |
| 3 Percent 2-Chloroprocaine and Epidural Morphine | Number of Participants Who Had Mild, Moderate or Severe Pruritis as Measured by a 3 Point Scale | 24 hours | 0 Participants |
| 3 Percent 2-Chloroprocaine and Epidural Morphine | Number of Participants Who Had Mild, Moderate or Severe Pruritis as Measured by a 3 Point Scale | 4 hours | 3 Participants |
| 3 Percent 2-Chloroprocaine and Epidural Morphine | Number of Participants Who Had Mild, Moderate or Severe Pruritis as Measured by a 3 Point Scale | 12 hours | 3 Participants |
| 3 Percent 2-Chloroprocaine and Epidural Morphine | Number of Participants Who Had Mild, Moderate or Severe Pruritis as Measured by a 3 Point Scale | 8 hours | 4 Participants |
Secondary
Pain as Measured by a 11 Point Verbal Scale
scale ranges form 0-10, higher number indicating more pain
Time frame: 4,8, 12 and 24 hours after epidural morphine administration
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| 2 Percent Lidocaine With Epinephrine and Epidural Morphine | Pain as Measured by a 11 Point Verbal Scale | 4 hours | 0 score on a scale |
| 2 Percent Lidocaine With Epinephrine and Epidural Morphine | Pain as Measured by a 11 Point Verbal Scale | 8 hours | 0 score on a scale |
| 2 Percent Lidocaine With Epinephrine and Epidural Morphine | Pain as Measured by a 11 Point Verbal Scale | 12 hours | 3 score on a scale |
| 2 Percent Lidocaine With Epinephrine and Epidural Morphine | Pain as Measured by a 11 Point Verbal Scale | 24 hours | 7 score on a scale |
| 3 Percent 2-Chloroprocaine and Epidural Morphine | Pain as Measured by a 11 Point Verbal Scale | 24 hours | 3.5 score on a scale |
| 3 Percent 2-Chloroprocaine and Epidural Morphine | Pain as Measured by a 11 Point Verbal Scale | 4 hours | 2.5 score on a scale |
| 3 Percent 2-Chloroprocaine and Epidural Morphine | Pain as Measured by a 11 Point Verbal Scale | 12 hours | 2 score on a scale |
| 3 Percent 2-Chloroprocaine and Epidural Morphine | Pain as Measured by a 11 Point Verbal Scale | 8 hours | 1 score on a scale |
Secondary
Time Until First Opioid Request
Time frame: Up to 48 hours after epidural morphine administration
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2 Percent Lidocaine With Epinephrine and Epidural Morphine | Time Until First Opioid Request | 14.8 hours |
| 3 Percent 2-Chloroprocaine and Epidural Morphine | Time Until First Opioid Request | 24.7 hours |
Secondary
Total Amount of Opioid Used
Time frame: 12 hours after epidural morphine administration
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2 Percent Lidocaine With Epinephrine and Epidural Morphine | Total Amount of Opioid Used | 0 hours |
| 3 Percent 2-Chloroprocaine and Epidural Morphine | Total Amount of Opioid Used | 0 hours |
Secondary
Total Amount of Opioid Used
Time frame: 8 hours after epidural morphine administration
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2 Percent Lidocaine With Epinephrine and Epidural Morphine | Total Amount of Opioid Used | 0 hours |
| 3 Percent 2-Chloroprocaine and Epidural Morphine | Total Amount of Opioid Used | 0 hours |
Secondary
Total Amount of Opioid Used
Time frame: 4 hours after epidural morphine administration
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2 Percent Lidocaine With Epinephrine and Epidural Morphine | Total Amount of Opioid Used | 0 hours |
| 3 Percent 2-Chloroprocaine and Epidural Morphine | Total Amount of Opioid Used | 0 hours |