Optimizing Anesthesia for Post Partum Tubal Ligations

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03993314
• Other study ID #: IRB-300003361
• Status: Terminated
• Phase: Phase 2
• Start date: August 13, 2019
• Est. completion date: December 3, 2020

Study information

• Verified date: December 2021
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: December 3, 2020
• Est. primary completion date: December 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

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:

• age less than 18 years old
• allergy to either local anesthetic class (amide or ester)
• contraindication to spinal anesthesia

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Drug:
• Chloroprocaine
Adding 5 cc 1% Chloroprocaine with 10 cc sterile saline in the epidural
• Bupivacaine
1 cc of 0.5% bupivacaine with 15 mcg fentanyl 10 cc of sterile saline in the epidural

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	10 minutes after spinal injection
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	10 minutes after spinal injection
Secondary	Epidural Activation	Number of patients who required epidural activation	Day of surgery
Secondary	Supplemental Intravenous Sedation or General Anesthesia	Number of patients who required supplemental intravenous sedation or general anesthesia	Day of surgery
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	10 minutes after spinal injection
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	60 minutes after spinal injection
Secondary	Time to PACU Discharge	Time required for readiness for discharge from Post Anesthesia Care Unit (PACU)	Day of surgery