Total Hip ArthroplastyPhase 4NCT02818894

Spinal Anesthesia in Total Hip Arthroplasty

A Phase 4 study testing Lidocaine and Bupivacaine in people with Total Hip Arthroplasty, run by Thomas L Bradbury at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Total Hip Arthroplasty
What is being tested?: Lidocaine and Bupivacaine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 135 participants
Where: 2 sitesUnited States
Study dates: 27 Sep 2016to 5 Mar 2020
Phase: Phase 4
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 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Radiographic evidence of symptomatic osteoarthritis in one or bilateral hips. Osteoarthritis will be defined as pain with weight-bearing at the hip articulation together with radiographic findings
Indicated for total hip arthroplasty
Agreement to undergo spinal anesthesia for surgery

Who cannot join

Patient refusal to undergo spinal anesthesia
Patients with a known history of lumbar or sacral spinal fusion.
Patients with a known history of prostate, urological, or kidney surgery.
Patients who need monitoring of urine output during surgery (including patients with confirmed renal disease, renal failure, chronic renal insufficiency, or an indwelling catheter at the time of surgery).
Current infection at site of injection
Women of child-bearing potential who are on Medicare (child-bearing potential will be determined prior to surgery per Anesthesia standard of care)

Show all 13Show fewer

Hypovolemia
Indeterminate neurologic disease
Allergy or hypersensitivity to the study medications
Currently taking any anti-coagulation medications or coagulopathic
Increased intracranial pressure
Subject is unable to make his/her own decision regarding the informed consent
Subject is unable to read/understand English

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Emory University Orthopaedic and Spine Hospital
Atlanta, Georgia, 30329
The Emory Clinic
Atlanta, Georgia, 30329

Other trials in United States

About this study

Official title: Comparison of Lidocaine Versus Bupivacaine Spinal Anesthesia in Total Hip Arthroplasty: A Randomized, Double-Blind, Prospective Study

Spinal anesthesia is commonly used in patients undergoing total hip replacements. The purpose of this study is to compare lidocaine to bupivacaine spinal anesthesia in patients having a total hip arthroplasty (THA). The objective of this study is to compare the two spinal anesthesia treatments in regards to transient neurological symptoms (TNS).

Read the detailed description

Most surgeons would agree total hip arthroplasty (THA) is one of the most successful surgical interventions. However, when it comes to the type of anesthesia to improve THA outcomes, surgeons do not agree. General anesthesia has been shown to be associated with increases in adverse events, increased operating room times and increased length of stay. Therefore, more surgeons are turning to spinal anesthesia for better pain control, decreased need for narcotics resulting in less nausea, sooner recovery of bowel function, and faster participation in physical therapy. All of these factors can lead to a sooner discharge from the hospital, which would lead to significant cost savings.

Transient neurological symptoms (TNS) are a concern of using spinal anesthesia and have been shown to occur up to 16-40% of the time with lidocaine. Symptoms of TNS have been described as pain, dysesthesia, or both that occur in the legs or buttocks and urinary retention after recovery from spinal anesthesia. Intensity of pain varies but can be quite severe. Symptoms can appear in a few hours, for up to 24 hours after surgery.

Lidocaine is the most widely used anesthetic due to its rapid onset, intense nerve blockade, and short duration of action. The risk of developing TNS after spinal anesthesia with lidocaine has been shown to be higher when compared to other anesthetics. However, it is unknown whether there are differences between patients who undergo spinal anesthesia with lidocaine versus bupivacaine in THA. This knowledge is important because it has been shown that bupivacaine spinal anesthesia is more effective than lidocaine with minimal adverse effects. A large randomized, prospective study is needed to prove the difference between the two types of anesthesia.

The primary objective of this study is to compare TNS among people who receive one of two spinal anesthesia treatments, lidocaine or bupivacaine. The study will be conducted on individuals who are indicated for THA and have agreed to have spinal anesthesia during their surgery. All patients will be randomized by a computer program and will receive either lidocaine or bupivacaine spinal anesthesia prior to their THA. In addition to TNS, other outcomes include urinary retention, hypotension, ambulation and length of hospital stay.

Conditions: Total Hip Arthroplasty
Being tested: Lidocaine, Bupivacaine
Keywords: Hip replacement, Total hip arthroplasty, Anterior total hip replacement, Transient neurological symptoms, Spinal anesthesia

What participants receive

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

LidocaineDrug
Spinal anesthesia administered prior to participant's THA
BupivacaineDrug
Spinal anesthesia administered prior to participant's THA

Study groups in NCT02818894
Study group	Role	What they receive
Lidocaine prior to THA	Active comparator	Participants scheduled for Total Hip Arthroplasty through anterior approach with Lidocaine spinal anesthesia and completing telephone questionnaires to see how they are feeling post-operation. Receives: Drug: Lidocaine
Bupivacaine prior to THA	Active comparator	Participants scheduled for Total Hip Arthroplasty through anterior approach with Bupivacaine spinal anesthesia and completing telephone questionnaires to see how they are feeling post-operation. Receives: Drug: Bupivacaine

What is being measured

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

Number of Participants With Transient Neurological Symptoms (TNS) on Day 1 Post-Operation
Following a prepared questionnaire, a study team member asked about TNS and pain that was not associated with the operation area. The count of participants reporting any type of TNS is presented here.
Measured: Day 1 (day of surgery) Post-Operation
Post-Operative Transient Neurological Symptoms Score on Day 1 Post-Operation
Following a prepared questionnaire, a study team member asked about symptoms of TNS and pain that was not associated with the operation area. Participants were asked to grade the symptoms on a verbal analogue scale from 0 to 10, with zero as no discomfort and ten as unbearable discomfort.
Measured: Day 1 (day of surgery) Post-Operation
Number of Participants With Transient Neurological Symptoms on Post-Operative Day 7
Following a prepared questionnaire, a study team member asked about TNS and pain that was not associated with the operation area. The count of participants reporting any type of TNS is presented here.
Measured: Post-Operative Day 7
Transient Neurological Symptoms Score on Post-Operative Day 7
Following a prepared questionnaire, a study team member asked about symptoms of TNS and pain that was not associated with the operation area. Participants were asked to grade the symptoms on a verbal analogue scale from 0 to 10, with zero as no discomfort and ten as unbearable discomfort.
Measured: Post-Operative Day 7
Number of Participants With Transient Neurological Symptoms on Post-Operative Day 14
Following a prepared questionnaire, a study team member asked about symptoms of TNS and pain not associated with the operation area. The count of participants reporting any type of TNS is presented here.
Measured: Post-Operative Day 14
Transient Neurological Symptoms Score on Post-Operative Day 14
Following a prepared questionnaire, a study team member asked about symptoms of TNS and pain that was not associated with the operation area. Participants were asked to grade the symptoms on a verbal analogue scale from 0 to 10, with zero as no discomfort and ten as unbearable discomfort.
Measured: Post-Operative Day 14

Secondary outcomes (4)

Number of Participants Voiding Without Complications After Recovery From Spinal Anesthesia
Urine retention after recovery from spinal anesthesia was assessed as the count of participants voiding without complications. Data were obtained through review of the inpatient records.
Measured: Day 1 (day of surgery) Post-Operation
Time to Ambulation After Recovery From Spinal Anesthesia
Time to ambulation after recovery from spinal anesthesia is assessed in minutes. Information about time to full ambulation was obtained by asking participants or from inpatient medical charts.
Measured: Day 1 (day of surgery) Post-Operation
Count of Participants With Hypotension
The number of participants experiencing hypotension, defined as systolic blood pressure of <90 mmHg, is presented here. Blood pressure information was obtained from reviewing the inpatient medical charts.
Measured: Day 1 (day of surgery) Post-Operation
Number of Participants Discharged 0, 1, or 2 Days Following Surgery
Hospital length of stay was obtained from inpatient charts. Length of stay was determined using the hospital admission dates and discharge dates, and was then categorized as being discharged the same day as the surgery, the day after surgery, or two days after surgery.
Measured: Up to Post-Operative Day 2

Timeline

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

27 Sep 20165 Mar 2020

First posted30 Jun 2016 (estimated)
Study start27 Sep 2016
Primary completion5 Mar 2020
Study completion5 Mar 2020

Why it stopped: This study was terminated due to pressing matters related to the COVID-19 pandemic - staff shortages and changes of personnel, data gaps due to the pandemic, participants not being able to continue follow-up visits, and ongoing enrollment issues.

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.
Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
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 4
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 135 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02818894
Sponsor's protocol ID: IRB00083867
Status last verified: Aug 2022
First submitted: 28 Jun 2016
Last updated: 23 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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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Comparison of Ultrasound-Guided Erector Spinae Plane Block and Quadro-Iliac Plane Block in Elective Primary Unilateral Total Hip Arthroplasty
Postoperative Pain, Hip Arthroplasty, Total
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Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty: A Randomized Controlled Trial
Anaesthetic Requirements During Total Hip Arthroplasty
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Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
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3D-Printed Pelvic Models for Planning Complex Total Hip Arthroplasty
Developmental Dysplasia of the Hip, Acetabular Bone Loss
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All Total Hip Arthroplasty trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Lidocaine Versus Bupivacaine Spinal Anesthesia in Total Hip Arthroplasty: A Randomized, Double-Blind, Prospective Study
ClinicalTrials.gov ID: NCT02818894
Acronym / sponsor ID: IRB00083867
Conditions: Total Hip Arthroplasty
Keywords: Hip replacement, Total hip arthroplasty, Anterior total hip replacement, Transient neurological symptoms, Spinal anesthesia
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: This study was terminated due to pressing matters related to the COVID-19 pandemic - staff shortages and changes of personnel, data gaps due to the pandemic, participants not being able to continue follow-up visits, and ongoing enrollment issues.
Enrolment: 135 participants (actual)
Lead sponsor: Thomas L BradburyUniversity, hospital or other
Study start: 27 Sep 2016 (actual)
Primary completion: 5 Mar 2020 (actual)
Study completion: 5 Mar 2020 (actual)
First posted: 30 Jun 2016 (estimated)
Results: Posted 23 Sep 2022

Clinical summary

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

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Lidocaine prior to THA	Active comparator	Drug: LidocaineParticipants scheduled for Total Hip Arthroplasty through anterior approach with Lidocaine spinal anesthesia and completing telephone questionnaires to see how they are feeling post-operation.
Bupivacaine prior to THA	Active comparator	Drug: BupivacaineParticipants scheduled for Total Hip Arthroplasty through anterior approach with Bupivacaine spinal anesthesia and completing telephone questionnaires to see how they are feeling post-operation.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Radiographic evidence of symptomatic osteoarthritis in one or bilateral hips. Osteoarthritis will be defined as pain with weight-bearing at the hip articulation together with radiographic findings
Indicated for total hip arthroplasty
Agreement to undergo spinal anesthesia for surgery

Key exclusion criteria (13 listed)

Patient refusal to undergo spinal anesthesia
Patients with a known history of lumbar or sacral spinal fusion.
Patients with a known history of prostate, urological, or kidney surgery.
Patients who need monitoring of urine output during surgery (including patients with confirmed renal disease, renal failure, chronic renal insufficiency, or an indwelling catheter at the time of surgery).
Current infection at site of injection

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
LidocaineSpinal anesthesia administered prior to participant's THA	Drug	Lidocaine prior to THA
BupivacaineSpinal anesthesia administered prior to participant's THA	Drug	Bupivacaine prior to THA

Primary outcome

Number of Participants With Transient Neurological Symptoms (TNS) on Day 1 Post-Operation
Time frame: Day 1 (day of surgery) Post-Operation
Following a prepared questionnaire, a study team member asked about TNS and pain that was not associated with the operation area. The count of participants reporting any type of TNS is presented here.
Post-Operative Transient Neurological Symptoms Score on Day 1 Post-Operation
Time frame: Day 1 (day of surgery) Post-Operation
Following a prepared questionnaire, a study team member asked about symptoms of TNS and pain that was not associated with the operation area. Participants were asked to grade the symptoms on a verbal analogue scale from 0 to 10, with zero as no discomfort and ten as unbearable discomfort.
Number of Participants With Transient Neurological Symptoms on Post-Operative Day 7
Time frame: Post-Operative Day 7
Following a prepared questionnaire, a study team member asked about TNS and pain that was not associated with the operation area. The count of participants reporting any type of TNS is presented here.
Transient Neurological Symptoms Score on Post-Operative Day 7
Time frame: Post-Operative Day 7
Following a prepared questionnaire, a study team member asked about symptoms of TNS and pain that was not associated with the operation area. Participants were asked to grade the symptoms on a verbal analogue scale from 0 to 10, with zero as no discomfort and ten as unbearable discomfort.
Number of Participants With Transient Neurological Symptoms on Post-Operative Day 14
Time frame: Post-Operative Day 14
Following a prepared questionnaire, a study team member asked about symptoms of TNS and pain not associated with the operation area. The count of participants reporting any type of TNS is presented here.
Transient Neurological Symptoms Score on Post-Operative Day 14
Time frame: Post-Operative Day 14
Following a prepared questionnaire, a study team member asked about symptoms of TNS and pain that was not associated with the operation area. Participants were asked to grade the symptoms on a verbal analogue scale from 0 to 10, with zero as no discomfort and ten as unbearable discomfort.

4 secondary outcomes

Number of Participants Voiding Without Complications After Recovery From Spinal Anesthesia
Time frame: Day 1 (day of surgery) Post-Operation
Time to Ambulation After Recovery From Spinal Anesthesia
Time frame: Day 1 (day of surgery) Post-Operation
Count of Participants With Hypotension
Time frame: Day 1 (day of surgery) Post-Operation
Number of Participants Discharged 0, 1, or 2 Days Following Surgery
Time frame: Up to Post-Operative Day 2

Results and safety

Results posted to the registry on 23 Sep 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lidocaine Spinal Anesthesia	67	11
Bupivacaine Spinal Anesthesia	68	12

Primary outcome: Number of Participants With Transient Neurological Symptoms (TNS) on Day 1 Post-Operation

Time frame: Day 1 (day of surgery) Post-Operation. Count of participants. Unit: Participants

Measure	Lidocaine Spinal Anesthesia n = 48	Bupivacaine Spinal Anesthesia n = 50
Value	3	1

Population analysed: This analysis includes participants who completed the Neurological Symptoms Checklist. Two participants were assessed for other outcomes post-operatively on day of surgery but TNS was not evaluated. Sixteen participants were not assessed post-operatively on day of surgery for any outcomes, or their records were lost. Details about some study visits are no longer available and the exact reasons for the missing data cannot be determined.

Primary outcome: Post-Operative Transient Neurological Symptoms Score on Day 1 Post-Operation

Time frame: Day 1 (day of surgery) Post-Operation. Mean (Standard Deviation). Unit: score on a scale

Measure	Lidocaine Spinal Anesthesia n = 3	Bupivacaine Spinal Anesthesia n = 1
Value	2 (1.0)	4 (0.0)

Population analysed: This analysis includes participants reporting any type of TNS following surgery, on the day of surgery.

Primary outcome: Number of Participants With Transient Neurological Symptoms on Post-Operative Day 7

Time frame: Post-Operative Day 7. Count of participants. Unit: Participants

Measure	Lidocaine Spinal Anesthesia n = 14	Bupivacaine Spinal Anesthesia n = 17
Value	3	4

Population analysed: This analysis includes participants who completed the Neurological Symptoms Checklist. One participant in the lidocaine group participated in the Post-Operative Day 7 follow-up phone call but did not complete the Neurological Symptoms Checklist. The remaining missing participants were lost to follow up, were not called for this follow-up assessment, or their records were lost. Details about some study visits are no longer available and the exact reasons for missing data cannot be determined.

Primary outcome: Transient Neurological Symptoms Score on Post-Operative Day 7

Time frame: Post-Operative Day 7. Mean (Standard Deviation). Unit: score on a scale

Measure	Lidocaine Spinal Anesthesia n = 3	Bupivacaine Spinal Anesthesia n = 4
Value	2.33 (2.52)	5.75 (4.19)

Population analysed: This analysis includes participants reporting any type of TNS during the Post-Operative Day 7 follow-up assessment.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Information on adverse events was collected from the day of surgery through the 14 Days Post-Operative phone call (15 days total).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lidocaine Spinal Anesthesia	0 of 67 (0%)	0 of 67 (0%)	0 of 67
Bupivacaine Spinal Anesthesia	0 of 68 (0%)	0 of 68 (0%)	0 of 68

Limitations and caveats (from the sponsor): The study was terminated due to extended suspension of the study related to personnel issues and pandemic-related issues. Missing data due to lost study records limited the number of available data points.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Total Hip Arthroplasty

Not yet recruiting
Comparison of Ultrasound-Guided Erector Spinae Plane Block and Quadro-Iliac Plane Block in Elective Primary Unilateral Total Hip Arthroplasty
Postoperative Pain, Hip Arthroplasty, Total
Not yet recruiting
Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty: A Randomized Controlled Trial
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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.

Thomas Bradbury, MD principal investigator

Emory University

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lidocaine and Bupivacaine in people with Total Hip Arthroplasty, run by Thomas L Bradbury at 2 sites 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 3 inclusion and 13 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: stopped early, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Sep 2022). 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?

Number of Participants With Transient Neurological Symptoms (TNS) on Day 1 Post-Operation (time frame: Day 1 (day of surgery) Post-Operation). The study lists 6 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 NCT02818894.

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 23 Sep 2022.