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Lack of recruitment due to COVID-19 pandemic; chloroprocaine shortage
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine | Active Comparator | 1 ml 0.5% isobaric bupivacaine (5 mg) + 15 mcg fentanyl intrathecal plus epidural volume extension (EVE) |
|
| Chloroprocaine | Experimental | 5 ml 1% spinal chloroprocaine (50 mg) intrathecal plus epidural volume extension (EVE) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chloroprocaine | Drug | Adding 5 cc 1% Chloroprocaine with 10 cc sterile saline in the epidural |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 10 minutes after spinal injection |
| 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 | 10 minutes after spinal injection |
| Measure | Description | Time Frame |
|---|---|---|
| Epidural Activation | Number of patients who required epidural activation | Day of surgery |
| Supplemental Intravenous Sedation or General Anesthesia | Number of patients who required supplemental intravenous sedation or general anesthesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark F Powell, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35223 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Chloroprocaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Count of Participants | Participants | 10 minutes after spinal injection |
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1 day. Adverse event data were collected on day of post-partum tubal litigation (PPTL), from preoperative period to discharge from post anesthesia care unit (PACU).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Powell | University of Alabama at Birmingham | 205-934-6007 | mfpowell@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 18, 2021 | Dec 16, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C004616 | chloroprocaine |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Bupivacaine | Drug | 1 cc of 0.5% bupivacaine with 15 mcg fentanyl 10 cc of sterile saline in the epidural |
|
| Day of surgery |
| 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 | 10 minutes after spinal injection |
| 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 | 60 minutes after spinal injection |
| Time to PACU Discharge | Time required for readiness for discharge from Post Anesthesia Care Unit (PACU) | Day of surgery |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| 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 |
|
|
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| 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 | Posted | Median | Inter-Quartile Range | score on a scale | 10 minutes after spinal injection |
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| Secondary | Epidural Activation | Number of patients who required epidural activation | Posted | Count of Participants | Participants | Day of surgery |
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| Secondary | Supplemental Intravenous Sedation or General Anesthesia | Number of patients who required supplemental intravenous sedation or general anesthesia | Posted | Count of Participants | Participants | Day of surgery |
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| 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 | Posted | Count of Participants | Participants | 10 minutes after spinal injection |
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| 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 | Posted | Count of Participants | Participants | 60 minutes after spinal injection |
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| Secondary | Time to PACU Discharge | Time required for readiness for discharge from Post Anesthesia Care Unit (PACU) | Posted | Median | Full Range | minutes | Day of surgery |
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| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | 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 | 0 | 6 | 0 | 6 | 0 | 6 |
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| D000588 |
| Amines |
| 2 = Ability to bend knees |
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| 3 = Ability to wiggle toes |
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| 4 = No movement of lower extremities |
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| 2 = Ability to bend knees |
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| 3 = Ability to wiggle toes |
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| 4 = No movement of lower extremities |
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