NCT02619409

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?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

November 30, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

February 11, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2016

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

July 17, 2018

Completed
Last Updated

June 6, 2023

Status Verified

May 1, 2023

Enrollment Period

8 months

First QC Date

November 30, 2015

Results QC Date

February 28, 2018

Last Update Submit

May 12, 2023

Conditions

Arthropathy of HipArthropathy of Knee

Outcome Measures

Primary Outcomes (2)

  • Duration of Sensory Block

    Duration of the sensory block at the T12 dermatome will be assessed in the post operative phase

    12 hours

  • Duration of Motor Block

    (hip felxion) of the non operative leg

    12 hours

Study Arms (5)

Bupivacaine Only

PLACEBO COMPARATOR

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

Drug: Bupivacaine Only

EPI25 group

ACTIVE COMPARATOR

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

Drug: EPI25

EPI50 group

ACTIVE COMPARATOR

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

Drug: EPI50 group

EPI75 group

ACTIVE COMPARATOR

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

Drug: EPI75 group

EPI100 group

ACTIVE COMPARATOR

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

Drug: EPI100 group

Interventions

Bupivacaine OnlyDRUG

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

Bupivacaine Only
EPI25DRUG

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

EPI25 group
EPI50 groupDRUG

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

EPI50 group
EPI75 groupDRUG

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

EPI75 group
EPI100 groupDRUG

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

EPI100 group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

  • Wolla CD, Epperson TI, Woltz EM, Wolf BJ, Bolin ED. Prolongation of spinal duration by escalating doses of intrathecal epinephrine in lower limb arthroplasty. Pain Manag. 2023 Nov;13(11):647-654. doi: 10.2217/pmt-2023-0068. Epub 2023 Nov 15.

    PMID: 37965771DERIVED

Results Point of Contact

Title
Dr. Eric Bolin
Organization
Medical University of South Carolina
bolin@musc.edu
8437922322

Study Officials

  • Eric Bolin, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 30, 2015

First Posted

December 2, 2015

Study Start

February 11, 2016

Primary Completion

October 20, 2016

Study Completion

October 20, 2016

Last Updated

June 6, 2023

Results First Posted

July 17, 2018

Record last verified: 2023-05

Locations

US(1)