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Evaluation of the Duration of Bupivacaine Spinal Block in Orthopedic Procedures With and Without Epinephrine Wash

Primary Purpose

Arthropathy of Hip, Arthropathy of Knee

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine Only
EPI25
EPI50 group
EPI75 group
EPI100 group
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthropathy of Hip

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 years of age or older
  • Patients scheduled for total hip or knee replacement

Exclusion Criteria:

  • Patients taking anticoagulation
  • Infection at or near the intended needle insertion site
  • Patients with sacral decubitus ulcer at or near the intended needle insertion site aortic stenosis
  • Complex spine anatomy
  • ASA class greater than III
  • Failed SAB as determined by the staff anesthesiologist

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Bupivacaine Only

EPI25 group

EPI50 group

EPI75 group

EPI100 group

Arm Description

The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc.

The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc.

The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc.

The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075 cc, and sterile saline 0.025%.

The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc

Outcomes

Primary Outcome Measures

Duration of Sensory Block
Duration of the sensory block at the T12 dermatome will be assessed in the post operative phase
Duration of Motor Block
(hip felxion) of the non operative leg

Secondary Outcome Measures

Full Information

First Posted
November 30, 2015
Last Updated
May 12, 2023
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT02619409
Brief Title
Evaluation of the Duration of Bupivacaine Spinal Block in Orthopedic Procedures With and Without Epinephrine Wash
Official Title
Evaluation of the Duration of Bupivacaine Spinal Block as the Primary Anesthetic for Orthopedic Procedures With and Without Epinephrine Wash
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 11, 2016 (Actual)
Primary Completion Date
October 20, 2016 (Actual)
Study Completion Date
October 20, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Bupivacaine spinal is commonly performed as the primary anesthetic for orthopedic procedures. In some cases the duration of the block is inadequate. An epinephrine wash is sometimes performed to prolong the duration of the block. The epinephrine wash may prolong the duration of the block, and if it does, to what extent?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthropathy of Hip, Arthropathy of Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine Only
Arm Type
Placebo Comparator
Arm Description
The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc.
Arm Title
EPI25 group
Arm Type
Active Comparator
Arm Description
The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc.
Arm Title
EPI50 group
Arm Type
Active Comparator
Arm Description
The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc.
Arm Title
EPI75 group
Arm Type
Active Comparator
Arm Description
The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075 cc, and sterile saline 0.025%.
Arm Title
EPI100 group
Arm Type
Active Comparator
Arm Description
The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Only
Intervention Description
The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc.
Intervention Type
Drug
Intervention Name(s)
EPI25
Intervention Description
The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc.
Intervention Type
Drug
Intervention Name(s)
EPI50 group
Intervention Description
The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc
Intervention Type
Drug
Intervention Name(s)
EPI75 group
Intervention Description
The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075cc, and sterile saline 0.025%.
Intervention Type
Drug
Intervention Name(s)
EPI100 group
Intervention Description
The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc.
Primary Outcome Measure Information:
Title
Duration of Sensory Block
Description
Duration of the sensory block at the T12 dermatome will be assessed in the post operative phase
Time Frame
12 hours
Title
Duration of Motor Block
Description
(hip felxion) of the non operative leg
Time Frame
12 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Patients scheduled for total hip or knee replacement Exclusion Criteria: Patients taking anticoagulation Infection at or near the intended needle insertion site Patients with sacral decubitus ulcer at or near the intended needle insertion site aortic stenosis Complex spine anatomy ASA class greater than III Failed SAB as determined by the staff anesthesiologist
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Bolin, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Duration of Bupivacaine Spinal Block in Orthopedic Procedures With and Without Epinephrine Wash

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