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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02619409
Enrollment
30
Registered
2015-12-02
Start date
2016-02-11
Completion date
2016-10-20
Last updated
2023-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthropathy of Hip, Arthropathy of Knee

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?

Interventions

DRUGBupivacaine Only

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

DRUGEPI25

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

DRUGEPI50 group

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

DRUGEPI75 group

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

DRUGEPI100 group

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

Sponsors

Medical University of South Carolina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Duration of Sensory Block12 hoursDuration of the sensory block at the T12 dermatome will be assessed in the post operative phase
Duration of Motor Block12 hours(hip felxion) of the non operative leg

Countries

United States

Participant flow

Participants by arm

ArmCount
Bupivacaine Only
The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc. Bupivacaine Only: The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc.
6
EPI25 Group
The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc. EPI25: The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc.
6
EPI50 Group
The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc. EPI50 group: The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc
6
EPI75 Group
The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075 cc, and sterile saline 0.025%. EPI75 group: The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075cc, and sterile saline 0.025%.
6
EPI100 Group
The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc EPI100 group: The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc.
6
Total30

Baseline characteristics

CharacteristicEPI100 GroupTotalBupivacaine OnlyEPI25 GroupEPI50 GroupEPI75 Group
Age, Continuous59 years64 years70 years63 years58 years67 years
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants0 Participants1 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants7 Participants3 Participants0 Participants2 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
6 Participants22 Participants3 Participants5 Participants4 Participants4 Participants
Sex: Female, Male
Female
5 Participants20 Participants5 Participants4 Participants4 Participants2 Participants
Sex: Female, Male
Male
1 Participants10 Participants1 Participants2 Participants2 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —— / —
other
Total, other adverse events
0 / 60 / 60 / 60 / 60 / 6
serious
Total, serious adverse events
0 / 60 / 60 / 60 / 60 / 6

Outcome results

Primary

Duration of Motor Block

(hip felxion) of the non operative leg

Time frame: 12 hours

ArmMeasureValue (MEAN)Dispersion
Bupivacaine OnlyDuration of Motor Block3.74 hoursStandard Deviation 1.13
EPI25 GroupDuration of Motor Block3.36 hoursStandard Deviation 0.47
EPI50 GroupDuration of Motor Block3.39 hoursStandard Deviation 0.6
EPI75 GroupDuration of Motor Block4.06 hoursStandard Deviation 0.98
EPI100 GroupDuration of Motor Block5.20 hoursStandard Deviation 1.41
Primary

Duration of Sensory Block

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

Time frame: 12 hours

ArmMeasureValue (MEAN)Dispersion
Bupivacaine OnlyDuration of Sensory Block3.41 hoursStandard Deviation 1.37
EPI25 GroupDuration of Sensory Block2.81 hoursStandard Deviation 0.42
EPI50 GroupDuration of Sensory Block3.23 hoursStandard Deviation 0.72
EPI75 GroupDuration of Sensory Block3.12 hoursStandard Deviation 0.61
EPI100 GroupDuration of Sensory Block3.22 hoursStandard Deviation 1.02

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026