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PainEarly Phase 1NCT03070054

LIA in Hip Arthroscopy Patients

A Early Phase 1 study testing 20ml 0.25% bupivacaine-epinephrine in people with Pain, run by University of Utah 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

The investigator's are conducting a randomized, blinded study to determine if the extra-capsular local infiltration analgesic (LIA) administration of 20ml 0.25% bupivacaine-epinephrine can improve the postoperative pain management of hip arthroscopy patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain
What is being tested?
20ml 0.25% bupivacaine-epinephrine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteUnited States
Study dates
Jun 2016to Mar 2020
Phase
Early Phase 1
Are there results?
None posted in the registry

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult (>18 years) patients who have elected for hip arthroscopy surgery.

Who cannot join

  • Patients who are undergoing bilateral hip arthroscopy in a single surgery.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Utah Orthopaedic Center

    Salt Lake City, Utah, 84108

Other trials in United States

About this study

Official title: LIA in Hip Arthroscopy Patients: An Extra-Capsular Approach

The investigator's are conducting a randomized, blinded study to determine if the extra-capsular local infiltration analgesic (LIA) administration of 20ml 0.25% bupivacaine-epinephrine can improve the postoperative pain management of hip arthroscopy patients. Participants will be randomly assigned to the LIA group or non-LIA group prior to surgery. Participants, anesthesiologists and PACU nurses will be blinded to group assignment, however the surgeon administering the LIA will be unblinded.

Read the detailed description

Hip arthroscopy is a growing field in orthopedic medicine that has gained momentum in recent years as a treatment for an array of hip pathologies including labral tears, chondral injuries, loose bodies, hip instability, femoroacetabular impingement, extraarticular lesions, synovial abnormalities, ruptured ligamentum teres, osteonecrosis, and mild-to-moderate osteoarthritis. With this increased rate of hip arthroscopy has come an interest in adequate postoperative pain management.

There are a number of strategies to improve post-operative orthopedic pain management. One common technique is the femoral block, during which a patient receives an ultrasound-guided injection of local analgesia administered in close proximity to the nerve. In the hip arthroscopy setting, postoperative femoral nerve blocks have been shown to significantly decrease pain, reduce opioid related symptoms like nausea, and have higher pain satisfaction scores than patients using only morphine. However, this option can be costly as it is a separate procedure billed by the anesthesiologist. Regional nerve blocks also carry the risk of residual parasthesia and permanent nerve damage, however rare.

One way to circumvent these limitations is through local infiltration analgesia (LIA), a technique that has been described for post-operative pain management in orthopedic modalities like total knee arthroscopy (TKA) and total hip arthroscopy (THA). Injection of analgesic directly to the surgical site can easily be incorporated as a brief step in the surgical procedure at a minimal cost to the patient. In THA and TKA, LIA has resulted in promising decreases in pain and opioid consumption. However, interpretation of these results in the context of hip arthroscopy has been confounded by the fundamental differences between THA/TKA and hip arthroscopy, the array of different strategies used in LIA (eg. continuous infiltration via a catheter vs. a single shot), and a lack of placebo or control group, and the specific location of injection.

In the setting of hip arthroscopy, a previous group tested intra-portal injections with mixed results. LIA targeting the highly innervated hip capsule, which is cut to access the joint during arthroscopy, may be more efficacious at limiting postoperative pain. LIA injection into the hip capsule can occur under direct visualization after capsular repair. To our knowledge, no studies have assessed the outcomes of this extracapsular LIA technique in the hip arthroscopy setting.

Documented risks involved with LIA are limited to the continuous infiltration via catheter. This approach has the risk of infection at the catheter site as well as cartilage damage. Our proposed technique avoids use of catheters and associated infection. The proposed single dose of 0.25% 20mL bupivacaine epinephrine a fraction of the dosages used in previous LIA studies to avoid chondral damage.

Conditions
Pain
Being tested
20ml 0.25% bupivacaine-epinephrine
Medical subject headings
Pain

What participants receive

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

  • 20ml 0.25% bupivacaine-epinephrineDrug

    Also called Marcaine, Sensorcaine

    Extra-capsular local infiltration analgesic (LIA) administration of 20ml 0.25% bupivacaine-epinephrine

Study groups in NCT03070054
Study groupRoleWhat they receive
ControlNo interventionnon-LIA group prior to surgery
TreatmentExperimentalExtra-capsular local infiltration analgesic (LIA) administration of 20ml 0.25% bupivacaine-epinephrine
Receives: Drug: 20ml 0.25% bupivacaine-epinephrine

What is being measured

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

  1. PACU pain scores

    Patient-reported pain in the postoperative anesthesia care unit (PACU).

    Measured: 1-day

Timeline

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

  1. First posted3 Mar 2017
  2. Study startJun 2016
  3. Primary completionMar 2020
  4. Study completionMar 2020

Resources

More details

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

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03070054
Sponsor's protocol ID
90371
Status last verified
Nov 2020
First submitted
28 Feb 2017
Last updated
10 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing 20ml 0.25% bupivacaine-epinephrine in people with Pain, run by University of Utah 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 1 inclusion and 1 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 10 May 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. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

PACU pain scores (time frame: 1-day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 10 May 2023; AzTrials last refreshed its copy on 30 Oct 2026.

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