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Optimizing Anesthesia for Post Partum Tubal Ligations

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ClinicalTrials.gov Identifier: NCT03993314
Recruitment Status : Terminated (Lack of recruitment due to COVID-19 pandemic; chloroprocaine shortage)
First Posted : June 20, 2019
Last Update Posted : September 27, 2021
Sponsor:
Information provided by (Responsible Party):
Mark Powell, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Pregnancy Related Drug: Chloroprocaine Drug: Bupivacaine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing 1% Spinal Chloroprocaine to Low-dose Bupivacaine Using the Epidural Volume Extension Technique for Post-Partum Tubal Ligation
Actual Study Start Date : August 13, 2019
Actual Primary Completion Date : December 3, 2020
Actual Study Completion Date : December 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care

Arm Intervention/treatment
Active Comparator: Bupivacaine Drug: Bupivacaine
1 cc of 0.5% bupivacaine with 15 mcg fentanyl 10 cc of sterile saline in the epidural

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




Primary Outcome Measures :
  1. Level of Numbness [ Time Frame: From 10 minutes before the time of drug administration to 2 hours after surgery completion ]
    The degree to which participants experience analgesia



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03993314


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35223
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Mark F Powell, MD University of Alabama at Birmingham
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Responsible Party: Mark Powell, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03993314    
Other Study ID Numbers: IRB-300003361
First Posted: June 20, 2019    Key Record Dates
Last Update Posted: September 27, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Bupivacaine
Chloroprocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents