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

NCT ID: NCT02619409

Last Updated: 2023-06-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-11

Study Completion Date

2016-10-20

Brief Summary

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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?

Detailed Description

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Conditions

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Arthropathy of Hip Arthropathy of Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Bupivacaine Only

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

Group Type PLACEBO_COMPARATOR

Bupivacaine Only

Intervention Type DRUG

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

EPI25 group

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

Group Type ACTIVE_COMPARATOR

EPI25

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

EPI50 group

Intervention Type DRUG

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 0.075 cc, and sterile saline 0.025%.

Group Type ACTIVE_COMPARATOR

EPI75 group

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

EPI100 group

Intervention Type DRUG

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

Interventions

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Bupivacaine Only

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

Intervention Type DRUG

EPI25

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

Intervention Type DRUG

EPI50 group

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

Intervention Type DRUG

EPI75 group

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

Intervention Type DRUG

EPI100 group

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Eric Bolin

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric Bolin, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37965771 (View on PubMed)

Other Identifiers

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Pro00039232

Identifier Type: -

Identifier Source: org_study_id

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