Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03070054 |
| Other study ID # |
90371 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Early Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
June 2016 |
| Est. completion date |
March 2020 |
Study information
| Verified date |
November 2020 |
| Source |
University of Utah |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
