NCT03110003

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 27, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
10 months until next milestone

Results Posted

Study results publicly available

September 13, 2018

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

December 19, 2018

Status Verified

November 1, 2018

Enrollment Period

1.4 years

First QC Date

March 30, 2017

Results QC Date

August 6, 2018

Last Update Submit

November 28, 2018

Conditions

Spinal AnesthesiaEpidural; Anesthesia

Keywords

Neuraxial epidural techniquesCombined spinal epiduralEpidural volume extensionTransient Neurologic Symptoms (TNS)

Outcome Measures

Primary Outcomes (1)

  • Time Until PACU Discharge in Minutes

    Time from entrance into the PACU until PACU discharge criteria met

    Baseline up to 48 hrs postoperatively

Secondary Outcomes (5)

  • Peak Block Height

    Baseline up to 3 hours

  • Degree of Peak Motor Blockade by Modified Bromage Scale

    Baseline up to 3 hours

  • Time Elapsed Until Motor Block Regresses to Modified Bromage Score = 0

    Baseline up to 6 hours

  • Quality of Block as Determined by Subjective Pain Assessment

    Baseline up to 6 hours

  • Patient Satisfaction as Determined by a Likert-type Scale

    At 6 hrs postoperatively

Study Arms (2)

10 mg Bupivacaine

ACTIVE COMPARATOR

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

Drug: 10 mg Bupivacaine

5 mg Bupivacaine

ACTIVE COMPARATOR

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.

Drug: 5 mg Bupivacaine

Interventions

10 mg BupivacaineDRUG

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

Also known as: Marcaine and Sensorcaine
10 mg Bupivacaine
5 mg BupivacaineDRUG

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.

Also known as: Marcaine and Sensorcaine
5 mg Bupivacaine

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAB Department of Anesthesiology and Perioperative Medicine

Birmingham, Alabama, 35249, United States

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Dr. Mark Powell
Organization
University of Alabama at Birmingham
mfpowell@uabmc.edu
205-975-3328

Study Officials

  • Mark Powell, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 30, 2017

First Posted

April 12, 2017

Study Start

June 27, 2016

Primary Completion

December 1, 2017

Study Completion

September 30, 2018

Last Updated

December 19, 2018

Results First Posted

September 13, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)