Optimizing Anesthesia for Post Partum Tubal Ligations

Study Overview
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Brief Summary
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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.

Official Title
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Comparing 1% Spinal Chloroprocaine to Low-dose Bupivacaine Using the Epidural Volume Extension Technique for Post-Partum Tubal Ligation

Conditions
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Pregnancy Related

Intervention / Treatment
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* Drug: Chloroprocaine
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacaine<br>1 ml 0.5% isobaric bupivacaine (5 mg) + 15 mcg fentanyl intrathecal plus epidural volume extension (EVE) | Drug: Bupivacaine<br>* 1 cc of 0.5% bupivacaine with 15 mcg fentanyl 10 cc of sterile saline in the epidural<br>|
| Experimental: Chloroprocaine<br>5 ml 1% spinal chloroprocaine (50 mg) intrathecal plus epidural volume extension (EVE) | Drug: Chloroprocaine<br>* Adding 5 cc 1% Chloroprocaine with 10 cc sterile saline in the epidural<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |