Optimizing Anesthesia for Post Partum Tubal Ligations

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

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 Overview

• Status: Terminated
• Conditions: Pregnancy Related
• Intervention / Treatment: Drug: Bupivacaine; Drug: Chloroprocaine

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35223
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Bupivacaine; 1 ml 0.5% isobaric bupivacaine (5 mg) + 15 mcg fentanyl intrathecal plus epidural volume extension (EVE)	Drug: Bupivacaine; 1 cc of 0.5% bupivacaine with 15 mcg fentanyl 10 cc of sterile saline in the epidural
EXPERIMENTAL: Chloroprocaine; 5 ml 1% spinal chloroprocaine (50 mg) intrathecal plus epidural volume extension (EVE)	Drug: Chloroprocaine; Adding 5 cc 1% Chloroprocaine with 10 cc sterile saline in the epidural

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 13, 2019
• Primary Completion (ACTUAL): December 3, 2020
• Study Completion (ACTUAL): December 3, 2020

Study Registration Dates

• First Submitted: June 17, 2019
• First Submitted That Met QC Criteria: June 17, 2019
• First Posted (ACTUAL): June 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 17, 2021
• Last Update Submitted That Met QC Criteria: December 16, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine; Chloroprocaine
• Other Study ID Numbers: IRB-300003361

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes