Optimizing Anesthesia for Post Partum Tubal Ligations

Phase 2

Terminated

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.

Recruitment & Eligibility

Inclusion Criteria

Any patient scheduled for a postpartum tubal ligation at the Women and Infants Center will be eligible for the study

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Bupivacaine	Bupivacaine	1 ml 0.5% isobaric bupivacaine (5 mg) + 15 mcg fentanyl intrathecal plus epidural volume extension (EVE)
Chloroprocaine	Chloroprocaine	5 ml 1% spinal chloroprocaine (50 mg) intrathecal plus epidural volume extension (EVE)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Supplemental Intravenous Sedation or General Anesthesia	Day of surgery	Number of patients who required supplemental intravenous sedation or general anesthesia
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
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
Epidural Activation	Day of surgery	Number of patients who required epidural activation