Pregnancy Related
Conditions
Brief summary
In this study, the investigators will compare CLOROTEKAL® (1% spinal chloroprocaine) to low-dose isobaric bupivacaine using the epidural volume extension (EVE) technique in patients undergoing post-partum tubal ligation (PPBTL). This will be a randomized, double-blinded study. Patients scheduled for PPBTL at the Women and Infants Center (WIC) will be eligible for enrollment in this study. Outcomes measured will include: ability to achieve an adequate level required for surgery (T6), rate of epidural activation, and duration of the block. The investigators hope to determine the usefulness of each drug using the EVE technique in the setting of PPBTL.
Interventions
DRUGChloroprocaine
Adding 5 cc 1% Chloroprocaine with 10 cc sterile saline in the epidural
DRUGBupivacaine
1 cc of 0.5% bupivacaine with 15 mcg fentanyl 10 cc of sterile saline in the epidural
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Any patient scheduled for a postpartum tubal ligation at the Women and Infants Center will be eligible for the study
Exclusion criteria
* age less than 18 years old * allergy to either local anesthetic class (amide or ester) * contraindication to spinal anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Achieve a Level of Numbness of T6 or Higher | 10 minutes after spinal injection | Degree of analgesia is determined by the level of the block. Block level may be T1 (highest level of numbness), T2, T3, T4, T5, T6, T7,T8, T9 , T10, T11, T12, L1, L2, L3, or L4 (lowest level or numbness). A level of numbness of T6 or higher is required for an adequate surgical block. Participants are classified as having either an adequate level of numbness (T1, T2, T3, T4, T5, or T6) or an inadequate level (T7,T8, T9 , T10, T11, T12, L1, L2, L3, or L4). |
| Level of Numbness | 10 minutes after spinal injection | The degree to which participants experience analgesia. Degree of analgesia is determined by the level of the block. Block level may be T1 (highest level of numbness), T2, T3, T4, T5, T6, T7,T8, T9 , T10, T11, T12, L1, L2, L3, or L4 (lowest level or numbness). Participants are assigned a numerical score according to level of the block. Numerical scores were assigned so that a higher score indicates better outcome (i.e., greater level of numbness): T1 = 16 points; T2 = 15 points; T3 = 14 points; T4 = 13 points; T5 = 12 points; T6 = 11 points; T7 = 10 points; T8 = 9 points; T9 = 8 points; T10 = 7 points; T11 = 6 points; T12 = 5 points; L1 = 4 points; L2 = 3 points; L3 = 2 points; L4 = 1 point |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Bromage Score at 10 Minutes Post-injection | 10 minutes after spinal injection | The modified Bromage score is an ordinal scale ranging from 0 to 4 with higher values indicating greater levels of numbness. 0 = ability to maintain leg lift for prolonged period; 1 = ability to lift legs briefly; 2 = ability to bend knees; 3 = ability to wiggle toes; 4 = no movement of lower extremities |
| Epidural Activation | Day of surgery | Number of patients who required epidural activation |
| Time to PACU Discharge | Day of surgery | Time required for readiness for discharge from Post Anesthesia Care Unit (PACU) |
| Modified Bromage Score 60 Minutes After Intrathecal Injection | 60 minutes after spinal injection | The modified Bromage score is an ordinal scale ranging from 0 to 4 with higher values indicating greater levels of numbness. 0 = ability to maintain leg lift for prolonged period; 1 = ability to lift legs briefly; 2 = ability to bend knees; 3 = ability to wiggle toes; 4 = no movement of lower extremities |
| Supplemental Intravenous Sedation or General Anesthesia | Day of surgery | Number of patients who required supplemental intravenous sedation or general anesthesia |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bupivacaine 1 ml 0.5% isobaric bupivacaine (5 mg) + 15 mcg fentanyl intrathecal plus epidural volume extension (EVE)
Bupivacaine: 1 cc of 0.5% bupivacaine with 15 mcg fentanyl 10 cc of sterile saline in the epidural | 9 |
| Chloroprocaine 5 ml 1% spinal chloroprocaine (50 mg) intrathecal plus epidural volume extension (EVE)
Chloroprocaine: Adding 5 cc 1% Chloroprocaine with 10 cc sterile saline in the epidural | 6 |
| Total | 15 |
Baseline characteristics
| Characteristic | Bupivacaine | Chloroprocaine | Total |
|---|---|---|---|
| Age, Continuous | 29.2 years STANDARD_DEVIATION 4.5 | 27.0 years STANDARD_DEVIATION 3.7 | 28.3 years STANDARD_DEVIATION 4.2 |
| Body Mass Index (BMI) | 33.0 kg/m^2 STANDARD_DEVIATION 7.1 | 31.7 kg/m^2 STANDARD_DEVIATION 5.3 | 32.5 kg/m^2 STANDARD_DEVIATION 6.3 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 9 participants | 6 participants | 15 participants |
| Sex: Female, Male Female | 9 Participants | 6 Participants | 15 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 / 9 | 0 / 6 |
| other Total, other adverse events | 0 / 9 | 0 / 6 |
| serious Total, serious adverse events | 0 / 9 | 0 / 6 |
Outcome results
Primary
Level of Numbness
The degree to which participants experience analgesia. Degree of analgesia is determined by the level of the block. Block level may be T1 (highest level of numbness), T2, T3, T4, T5, T6, T7,T8, T9 , T10, T11, T12, L1, L2, L3, or L4 (lowest level or numbness). Participants are assigned a numerical score according to level of the block. Numerical scores were assigned so that a higher score indicates better outcome (i.e., greater level of numbness): T1 = 16 points; T2 = 15 points; T3 = 14 points; T4 = 13 points; T5 = 12 points; T6 = 11 points; T7 = 10 points; T8 = 9 points; T9 = 8 points; T10 = 7 points; T11 = 6 points; T12 = 5 points; L1 = 4 points; L2 = 3 points; L3 = 2 points; L4 = 1 point
Time frame: 10 minutes after spinal injection
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bupivacaine | Level of Numbness | 15 score on a scale |
| Chloroprocaine | Level of Numbness | 12.5 score on a scale |
Comparison: Exact Wilcoxon test of the null hypothesis that there is no difference between the median level of numbness between the two groups.p-value: 0.186Wilcoxon (Mann-Whitney)
Primary
Number of Patients Who Achieve a Level of Numbness of T6 or Higher
Degree of analgesia is determined by the level of the block. Block level may be T1 (highest level of numbness), T2, T3, T4, T5, T6, T7,T8, T9 , T10, T11, T12, L1, L2, L3, or L4 (lowest level or numbness). A level of numbness of T6 or higher is required for an adequate surgical block. Participants are classified as having either an adequate level of numbness (T1, T2, T3, T4, T5, or T6) or an inadequate level (T7,T8, T9 , T10, T11, T12, L1, L2, L3, or L4).
Time frame: 10 minutes after spinal injection
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bupivacaine | Number of Patients Who Achieve a Level of Numbness of T6 or Higher | Adequate level of numbness | 8 Participants |
| Bupivacaine | Number of Patients Who Achieve a Level of Numbness of T6 or Higher | Inadequate level of numbness | 1 Participants |
| Chloroprocaine | Number of Patients Who Achieve a Level of Numbness of T6 or Higher | Adequate level of numbness | 5 Participants |
| Chloroprocaine | Number of Patients Who Achieve a Level of Numbness of T6 or Higher | Inadequate level of numbness | 1 Participants |
Comparison: Exact Farrington-Manning (Score) test of the null hypothesis that there is no difference between the proportion of patients achieving a level of numbness of T6 or higher between the two groups.p-value: 0.757Farrington-Manning (Score) test
Secondary
Epidural Activation
Number of patients who required epidural activation
Time frame: Day of surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bupivacaine | Epidural Activation | Epidural activated | 5 Participants |
| Bupivacaine | Epidural Activation | Epidural not activated | 4 Participants |
| Chloroprocaine | Epidural Activation | Epidural activated | 1 Participants |
| Chloroprocaine | Epidural Activation | Epidural not activated | 5 Participants |
Comparison: Exact Farrington-Manning (Score) test of the null hypothesis that there is no difference between the proportion of patients requiring epidural activation between the two groups.p-value: 0.132Farrington-Manning (Score) test
Secondary
Modified Bromage Score 60 Minutes After Intrathecal Injection
The modified Bromage score is an ordinal scale ranging from 0 to 4 with higher values indicating greater levels of numbness. 0 = ability to maintain leg lift for prolonged period; 1 = ability to lift legs briefly; 2 = ability to bend knees; 3 = ability to wiggle toes; 4 = no movement of lower extremities
Time frame: 60 minutes after spinal injection
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bupivacaine | Modified Bromage Score 60 Minutes After Intrathecal Injection | 1 = Ability to lift legs briefly | 2 Participants |
| Bupivacaine | Modified Bromage Score 60 Minutes After Intrathecal Injection | 3 = Ability to wiggle toes | 2 Participants |
| Bupivacaine | Modified Bromage Score 60 Minutes After Intrathecal Injection | 2 = Ability to bend knees | 1 Participants |
| Bupivacaine | Modified Bromage Score 60 Minutes After Intrathecal Injection | 4 = No movement of lower extremities | 2 Participants |
| Bupivacaine | Modified Bromage Score 60 Minutes After Intrathecal Injection | 0 = Ability to maintain leg lift for prolonged period | 2 Participants |
| Chloroprocaine | Modified Bromage Score 60 Minutes After Intrathecal Injection | 4 = No movement of lower extremities | 1 Participants |
| Chloroprocaine | Modified Bromage Score 60 Minutes After Intrathecal Injection | 0 = Ability to maintain leg lift for prolonged period | 0 Participants |
| Chloroprocaine | Modified Bromage Score 60 Minutes After Intrathecal Injection | 1 = Ability to lift legs briefly | 1 Participants |
| Chloroprocaine | Modified Bromage Score 60 Minutes After Intrathecal Injection | 2 = Ability to bend knees | 3 Participants |
| Chloroprocaine | Modified Bromage Score 60 Minutes After Intrathecal Injection | 3 = Ability to wiggle toes | 1 Participants |
Comparison: Exact Wilcoxon test of the null hypothesis that there is no difference between the median modified Bromage score between the two groups.p-value: 0.674Wilcoxon (Mann-Whitney)
Secondary
Modified Bromage Score at 10 Minutes Post-injection
The modified Bromage score is an ordinal scale ranging from 0 to 4 with higher values indicating greater levels of numbness. 0 = ability to maintain leg lift for prolonged period; 1 = ability to lift legs briefly; 2 = ability to bend knees; 3 = ability to wiggle toes; 4 = no movement of lower extremities
Time frame: 10 minutes after spinal injection
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bupivacaine | Modified Bromage Score at 10 Minutes Post-injection | 1 = Ability to lift legs briefly | 2 Participants |
| Bupivacaine | Modified Bromage Score at 10 Minutes Post-injection | 3 = Ability to wiggle toes | 2 Participants |
| Bupivacaine | Modified Bromage Score at 10 Minutes Post-injection | 2 = Ability to bend knees | 4 Participants |
| Bupivacaine | Modified Bromage Score at 10 Minutes Post-injection | 4 = No movement of lower extremities | 0 Participants |
| Bupivacaine | Modified Bromage Score at 10 Minutes Post-injection | 0 = Ability to maintain leg lift for prolonged period | 1 Participants |
| Chloroprocaine | Modified Bromage Score at 10 Minutes Post-injection | 4 = No movement of lower extremities | 3 Participants |
| Chloroprocaine | Modified Bromage Score at 10 Minutes Post-injection | 0 = Ability to maintain leg lift for prolonged period | 0 Participants |
| Chloroprocaine | Modified Bromage Score at 10 Minutes Post-injection | 1 = Ability to lift legs briefly | 0 Participants |
| Chloroprocaine | Modified Bromage Score at 10 Minutes Post-injection | 2 = Ability to bend knees | 0 Participants |
| Chloroprocaine | Modified Bromage Score at 10 Minutes Post-injection | 3 = Ability to wiggle toes | 3 Participants |
Comparison: Exact Wilcoxon test of the null hypothesis that there is no difference between the median modified Bromage score between the two groups.p-value: 0.004Wilcoxon (Mann-Whitney)
Secondary
Supplemental Intravenous Sedation or General Anesthesia
Number of patients who required supplemental intravenous sedation or general anesthesia
Time frame: Day of surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bupivacaine | Supplemental Intravenous Sedation or General Anesthesia | Supplemental IV sedation or general anesthesia | 5 Participants |
| Bupivacaine | Supplemental Intravenous Sedation or General Anesthesia | No supplemental IV sedation or general anesthesia | 4 Participants |
| Chloroprocaine | Supplemental Intravenous Sedation or General Anesthesia | Supplemental IV sedation or general anesthesia | 3 Participants |
| Chloroprocaine | Supplemental Intravenous Sedation or General Anesthesia | No supplemental IV sedation or general anesthesia | 3 Participants |
Comparison: Exact Farrington-Manning (Score) test of the null hypothesis that there is no difference between the proportion of patients requiring supplemental IV sedation or general anesthesia between the two groups.p-value: 0.833Farrington-Manning (Score) test
Secondary
Time to PACU Discharge
Time required for readiness for discharge from Post Anesthesia Care Unit (PACU)
Time frame: Day of surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bupivacaine | Time to PACU Discharge | 57 minutes |
| Chloroprocaine | Time to PACU Discharge | 45 minutes |
Comparison: Log-rank test of the null hypothesis that there is no difference in the time to discharge from the Post Anesthesia Care Unit (PACU) between the two groups.p-value: 0.196Log Rank