Optimizing Anesthesia for Post Partum Tubal Ligations

NCT03993314 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: IRB-300003361
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Epidural Activation

  Day of surgery

• Supplemental Intravenous Sedation or General Anesthesia

  Day of surgery

• Modified Bromage Score at 10 Minutes Post-injection

  10 minutes after spinal injection

• Modified Bromage Score 60 Minutes After Intrathecal Injection

  60 minutes after spinal injection

• Time to PACU Discharge

  Day of surgery

Study Arms (2)

Bupivacaine

ACTIVE COMPARATOR

1 ml 0.5% isobaric bupivacaine (5 mg) + 15 mcg fentanyl intrathecal plus epidural volume extension (EVE)

Drug: Bupivacaine

Chloroprocaine

EXPERIMENTAL

5 ml 1% spinal chloroprocaine (50 mg) intrathecal plus epidural volume extension (EVE)

Drug: Chloroprocaine

Interventions

Chloroprocaine DRUG

Adding 5 cc 1% Chloroprocaine with 10 cc sterile saline in the epidural

Chloroprocaine

Bupivacaine DRUG

1 cc of 0.5% bupivacaine with 15 mcg fentanyl 10 cc of sterile saline in the epidural

Bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35223, United States

Location

MeSH Terms

Interventions

chloroprocaine; Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Mark Powell
• Organization: University of Alabama at Birmingham

mfpowell@uabmc.edu

205-934-6007

Study Officials

• Mark F Powell, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 20, 2019
• Study Start: August 13, 2019
• Primary Completion: December 3, 2020
• Study Completion: December 3, 2020
• Last Updated: December 17, 2021
• Results First Posted: December 17, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)