MedDataX Logo

Bupivacaine With Epidural Volume Extension

NCT ID: NCT03110003

Last Updated: 2018-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-27

Study Completion Date

2018-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In this study the investigator will address the efficacy of using low dose bupivacaine spinal anesthesia (SA) in combination with epidural volume extension (EVE) for patients undergoing short obstetric procedures.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Due to risks to both the mother and fetus, neuraxial anesthesia - spinal, epidural, or combined spinal-epidural (CSE) - is preferred over general anesthesia for all obstetrical procedures. However, one downside to neuraxial anesthesia is the increased time patients have to stay in the post-anesthesia care unit (PACU) due to residual numbness from the neuraxial block. In this study, the investigators will address the efficacy of using low dose bupivacaine spinal anesthesia (SA) in combination with epidural volume extension (EVE) for patients undergoing short obstetric procedures. This will be accomplished by performing a CSE with: 1) injecting the local anesthesia in the spinal space; 2) injecting sterile saline into the epidural space to help increase the spread of the local anesthesia in the spinal space. The idea is that physicians will be able to use less local anesthetic due to getting a greater spread of medication. This lower amount of local anesthetic will lead to a decreased duration of the spinal block; therefore, it will significantly decrease PACU length of stay. This technique will be compared to our traditional dose of spinal anesthetic without EVE in the CSE. Both groups will have an epidural catheter in place to allow us to give any additional local anesthetic to keep the patient comfortable throughout the procedure if the spinal anesthesia begins to wear off. The aim of this study is to determine if low dose spinal bupivacaine in conjunction with EVE can decrease the PACU recovery time for short obstetric procedures while still providing an adequate surgical block.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Anesthesia Epidural; Anesthesia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Neuraxial epidural techniques Combined spinal epidural Epidural volume extension Transient Neurologic Symptoms (TNS)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

10 mg Bupivacaine

Subjects will receive 10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl.

Group Type ACTIVE_COMPARATOR

10 mg Bupivacaine

Intervention Type DRUG

10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl injected to the epidural space

5 mg Bupivacaine

Subjects will receive 5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.

Group Type ACTIVE_COMPARATOR

5 mg Bupivacaine

Intervention Type DRUG

5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

10 mg Bupivacaine

10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl injected to the epidural space

Intervention Type DRUG

5 mg Bupivacaine

5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Marcaine and Sensorcaine Marcaine and Sensorcaine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients undergoing short obstetric procedure in the operating room requiring neuraxial anesthesia.

Exclusion Criteria

* coagulopathy
* platelets \<80,000
* allergy to local anesthetic or fentanyl
* previous spinal surgery
* spinal or intracranial mass
* history of lower extremity weakness
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mark Powell

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mark Powell, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UAB Department of Anesthesiology and Perioperative Medicine

Birmingham, Alabama, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

F1605020005

Identifier Type: -

Identifier Source: org_study_id