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

May 12, 2023 updated by: Eric Bolin, Medical University of South Carolina

Evaluation of the Duration of Bupivacaine Spinal Block as the Primary Anesthetic for Orthopedic Procedures With and Without Epinephrine Wash

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Bupivacaine Only
The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc.
Drug: Bupivacaine Only
The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc.
Active Comparator: EPI25 group
The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc.
Drug: EPI25
The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc.
Active Comparator: EPI50 group
The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc.
Drug: EPI50 group
The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc
Active Comparator: EPI75 group
The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075 cc, and sterile saline 0.025%.
Drug: EPI75 group
The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075cc, and sterile saline 0.025%.
Active Comparator: EPI100 group
The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc
Drug: EPI100 group
The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Sensory Block
Time Frame: 12 hours
Duration of the sensory block at the T12 dermatome will be assessed in the post operative phase
12 hours
Duration of Motor Block
Time Frame: 12 hours
(hip felxion) of the non operative leg
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Investigators

  • Principal Investigator: Eric Bolin, MD, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2016

Primary Completion (Actual)

October 20, 2016

Study Completion (Actual)

October 20, 2016

Study Registration Dates

First Submitted

November 30, 2015

First Submitted That Met QC Criteria

December 1, 2015

First Posted (Estimated)

December 2, 2015

Study Record Updates

Last Update Posted (Actual)

June 6, 2023

Last Update Submitted That Met QC Criteria

May 12, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00039232

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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