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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
15
Adding 5 cc 1% Chloroprocaine with 10 cc sterile saline in the epidural
1 cc of 0.5% bupivacaine with 15 mcg fentanyl 10 cc of sterile saline in the epidural
University of Alabama at Birmingham
Birmingham, Alabama, United States
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
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
Epidural Activation
Number of patients who required epidural activation
Time frame: Day of surgery
Supplemental Intravenous Sedation or General Anesthesia
Number of patients who required supplemental intravenous sedation or general anesthesia
Time frame: 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
Time frame: 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
Time frame: 60 minutes after spinal injection
Time to PACU Discharge
Time required for readiness for discharge from Post Anesthesia Care Unit (PACU)
Time frame: Day of surgery
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