Clinical trial NCT04353414: Transmuscular Quadratus Lumborum Block Plus Pericapsular Injection vs Pericapsular Injection
Official title: Transmuscular Quadratus Lumborum Block Plus Pericapsular Injection vs Pericapsular Injection for Patients Undergoing Primary Hip Arthroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hip Pain Chronic
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to compare two different treatment options on their effectiveness to reduce post-operative pain, narcotic (opioid pain medication) usage and recovery time in patients undergoing primary hip arthroscopy surgery.

The first treatment option is a Transmuscular Quadratus Lumborum (TQL) block plus hip incision site (Pericapsular) Injection. The TQL block is an ultrasound guided injection between the quadratus lumborum and the psoas muscles in the back. The anesthesiologist will perform the TQL block The second treatment option is only a hip incision site (Pericapsular) Injection. In this group, the surgeon will inject local anesthetic into the incision or hip portal sites to decrease sensation.

Detailed description: This is a phase IV, randomized, single-blind, single-center study comparing postoperative pain, opioid usage and Post-Anesthesia Care Unit (PACU) recovery time for patients who receive a Transmuscular Quadratus Lumborum block (TQLB) plus pericapsular injection versus pericapsular injection (PCI) undergoing primary hip arthroscopy.

Eligibility criteria: Inclusion Criteria:

* Patients between 18 and 65 years of age
* Patients undergoing Primary Hip Arthroscopy
* Patients diagnosed with femoroacetabular impingement (FAI)
* Patients who consent to be randomized.

Exclusion Criteria:

* Patients younger than 18 and older than 65;
* Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer;
* Patients with diagnosed or self-reported cognitive dysfunction;
* Patients with a history of neurologic disorder that can interfere with pain sensation;
* Patients with a history of drug or recorded alcohol abuse;
* Patients who are unable to understand or follow instructions;
* Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;
* Patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures;
* Patients with BMI over 40;
* Any patient that the investigators feel cannot comply with all study related procedures.

Primary outcomes:
measure: Comparison of post-operative pain as per the Visual Analogue Scale (VAS)
timeFrame: 1 Day of surgery
measure: Comparison of post-operative pain as per the McGill pain scores
timeFrame: 1 Day of surgery
Secondary outcomes:
measure: Use of Opioids by participants
timeFrame: 1 Day of surgery
measure: Comparison in Post-Anesthesia Care Unit (PACU) Phase 1 recovery time by treatment group
timeFrame: 1 Day of surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Uchenna Umeh, MD
role: PRINCIPAL_INVESTIGATOR
References: