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

Arthropathy of Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02619409
• Other study ID #: Pro00039232
• Status: Completed
• Phase: N/A
• Start date: February 11, 2016
• Est. completion date: October 20, 2016

Study information

• Verified date: May 2023
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 20, 2016
• Est. primary completion date: October 20, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthropathy of Hip
• Arthropathy of Knee
• Joint Diseases

Intervention

Drug:
• Bupivacaine Only
The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc.
• EPI25
The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc.
• EPI50 group
The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc
• EPI75 group
The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075cc, and sterile saline 0.025%.
• EPI100 group
The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Sensory Block	Duration of the sensory block at the T12 dermatome will be assessed in the post operative phase	12 hours
Primary	Duration of Motor Block	(hip felxion) of the non operative leg	12 hours