Arthropathy of HipNCT02619409

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

A study testing Bupivacaine Only, EPI25 and EPI50 group in people with Arthropathy of Hip and Arthropathy of Knee, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Arthropathy of Hip, Arthropathy of Knee
What is being tested?: Bupivacaine Only, EPI25 and EPI50 group
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 11 Feb 2016to 20 Oct 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Medical University of South Carolina
Charleston, South Carolina, 29425

Other trials in United States

About this study

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

Conditions: Arthropathy of Hip, Arthropathy of Knee
Being tested: Bupivacaine Only, EPI25, EPI50 group, EPI75 group, EPI100 group

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bupivacaine OnlyDrug
The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc.
EPI25Drug
The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc.
EPI50 groupDrug
The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc
EPI75 groupDrug
The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075cc, and sterile saline 0.025%.
EPI100 groupDrug
The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc.

Study groups in NCT02619409
Study group	Role	What they receive
Bupivacaine Only	Placebo comparator	The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc. Receives: 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. Receives: 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. Receives: 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%. Receives: Drug: EPI75 group
EPI100 group	Active comparator	The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc Receives: Drug: EPI100 group

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Feb 201620 Oct 2016

First posted2 Dec 2015 (estimated)
Study start11 Feb 2016
Primary completion20 Oct 2016
Study completion20 Oct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Arthropathy of HipStudies of the same condition, open and under way.
More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02619409
Sponsor's protocol ID: Pro00039232
Status last verified: May 2023
First submitted: 30 Nov 2015
Last updated: 6 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 37965771

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
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Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
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Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
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All Arthropathy of Hip trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Duration of Bupivacaine Spinal Block as the Primary Anesthetic for Orthopedic Procedures With and Without Epinephrine Wash
ClinicalTrials.gov ID: NCT02619409
Acronym / sponsor ID: Pro00039232
Conditions: Arthropathy of Hip, Arthropathy of Knee
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Study start: 11 Feb 2016 (actual)
Primary completion: 20 Oct 2016 (actual)
Study completion: 20 Oct 2016 (actual)
First posted: 2 Dec 2015 (estimated)
Results: Posted 17 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Bupivacaine Only	Placebo comparator	Drug: Bupivacaine OnlyThe bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc.
EPI25 group	Active comparator	Drug: EPI25The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc.
EPI50 group	Active comparator	Drug: EPI50 groupThe EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc.
EPI75 group	Active comparator	Drug: EPI75 groupThe EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075 cc, and sterile saline 0.025%.
EPI100 group	Active comparator	Drug: EPI100 groupThe EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bupivacaine OnlyThe bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc.	Drug	Bupivacaine Only
EPI25The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc.	Drug	EPI25 group
EPI50 groupThe EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc	Drug	EPI50 group
EPI75 groupThe EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075cc, and sterile saline 0.025%.	Drug	EPI75 group
EPI100 groupThe EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc.	Drug	EPI100 group

Primary outcome

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
Duration of Motor Block
Time frame: 12 hours
(hip felxion) of the non operative leg

Results and safety

Results posted to the registry on 17 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bupivacaine Only	6	6
EPI25 Group	6	6
EPI50 Group	6	6
EPI75 Group	6	6
EPI100 Group	6	6

Primary outcome: Duration of Sensory Block

Time frame: 12 hours. Mean (Standard Deviation). Unit: hours

Measure	Bupivacaine Only n = 6	EPI25 Group n = 6	EPI50 Group n = 6	EPI75 Group n = 6	EPI100 Group n = 6
Value	3.41 (1.37)	2.81 (0.42)	3.23 (0.72)	3.12 (0.61)	3.22 (1.02)

Primary outcome: Duration of Motor Block

Time frame: 12 hours. Mean (Standard Deviation). Unit: hours

Measure	Bupivacaine Only n = 6	EPI25 Group n = 6	EPI50 Group n = 6	EPI75 Group n = 6	EPI100 Group n = 6
Value	3.74 (1.13)	3.36 (0.47)	3.39 (0.60)	4.06 (0.98)	5.20 (1.41)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bupivacaine Only	0 of 6 (0%)	0 of 6 (0%)	Not reported
EPI25 Group	0 of 6 (0%)	0 of 6 (0%)	Not reported
EPI50 Group	0 of 6 (0%)	0 of 6 (0%)	Not reported
EPI75 Group	0 of 6 (0%)	0 of 6 (0%)	Not reported
EPI100 Group	0 of 6 (0%)	0 of 6 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37965771Wolla 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.

Related trials for Arthropathy of Hip

Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Hip Disease, Hip Dysplasia
Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eric Bolin, MD principal investigator

Medical University of South Carolina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Bupivacaine Only, EPI25 and EPI50 group in people with Arthropathy of Hip and Arthropathy of Knee, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of Sensory Block (time frame: 12 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02619409, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.