NCT04353414

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2022

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2022

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

1.5 years

First QC Date

April 15, 2020

Last Update Submit

February 25, 2022

Conditions

Hip Pain Chronic

Outcome Measures

Primary Outcomes (2)

  • Comparison of post-operative pain as per the Visual Analogue Scale (VAS)

    This will be measured by using Visual Analogue Scale (VAS) pain scores and compared between the 2 treatment groups after surgery. The distribution of pain Visual Analogue Scale (VAS) scores in post- surgical patients will describe their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain Visual Analogue Scale (VAS) have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).

    1 Day of surgery

  • Comparison of post-operative pain as per the McGill pain scores

    This will be determined by the McGill Pain questionnaire (MPQ) scores and compared between the 2 treatment groups during the post-operative period. The MPQ assesses three separate components of the pain experience: the sensory intensity, the emotional impact and the cognitive evaluation of pain. Each descriptor is ranked on a 0 ("none") to 3 ("severe") intensity scale.

    1 Day of surgery

Secondary Outcomes (2)

  • Use of Opioids by participants

    1 Day of surgery

  • Comparison in Post-Anesthesia Care Unit (PACU) Phase 1 recovery time by treatment group

    1 Day of surgery

Study Arms (2)

Pericapsular Injection (PCI) group

ACTIVE COMPARATOR

Subjects in PCI group will receive the injection through both hip portals administered by the surgeon. 10 mL of 0.25% Bupivacaine Hydrochloride (HCL) will be injected through the anterolateral portal while the additional 10 mL will be injected through the mid-anterior portal.

Procedure: Pericapsular injectionDrug: Bupivacaine Hydrochloride

Transmuscular QL Block + Pericapsular Injection (PCI) group

ACTIVE COMPARATOR

Subjects in the TQLB group will receive the TQLB containing 30mL of 0.5% Bupivacaine Hydrochloride (HCL) plus PCI containing 20 mL of 0.25% of Bupivacaine Hydrochloride (HCL). For PCI, subjects will receive the injection through both hip portals administered by the surgeon. 10 mL of 0.25% Bupivacaine Hydrochloride (HCL) will be injected through the anterolateral portal while the additional 10 mL will be injected through the mid-anterior portal.

Procedure: Transmuscular Quadratus Lumborum BlockProcedure: Pericapsular injectionDrug: Bupivacaine Hydrochloride

Interventions

Transmuscular Quadratus Lumborum BlockPROCEDURE

Transmuscular Quadratus Lumborum Block (TQLB) is a relatively new block that targets thoracic and lumbar nerves. The decrease in sensation means a decrease in pain. The TQL block will be preformed in addition to an incision-site injection (on hip), called pericapsular injection. The potential risks associated with the Transmuscular Quadratus Lumborum Block (TQLB) include nerve damage and infection at injection site. In addition, there can be temporary sensory and motor loss, depending on the dosage, site of injection and duration of the nerve block. However, the amount (30mL) used in this study meets FDA dosage-regulations for this medication.

Transmuscular QL Block + Pericapsular Injection (PCI) group
Pericapsular injectionPROCEDURE

Pericapsular injection (PCI) of 20 mL of 0.25% Bupivacaine HCL (numbing medication) into the incision-site (hip portal sites) to decrease sensation. The potential risks associated with the pericapsular injection include bleeding, infection at injection site and local anesthetic toxicity however, the likelihood is low due to the expertise of the surgeon preforming the injection and the sterile environment and good clinical practice from clinicians, which reduces the likelihood of infection.

Pericapsular Injection (PCI) groupTransmuscular QL Block + Pericapsular Injection (PCI) group
Bupivacaine HydrochlorideDRUG

Bupivacaine used for this study is the standard of care for both TQLB and PCI. Pericapsular injection (PCI) contains 10 mL of 0.25% Bupivacaine HCL which will be injected through the anterolateral portal while the additional 10 mL will be injected through the mid-anterior portal.

Pericapsular Injection (PCI) groupTransmuscular QL Block + Pericapsular Injection (PCI) group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Uchenna Umeh, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2020

First Posted

April 20, 2020

Study Start

August 1, 2020

Primary Completion

February 17, 2022

Study Completion

February 23, 2022

Last Updated

March 2, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria
The investigator who proposed to use the data. Upon reasonable request. Requests should be directed to uchenna.umeh@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US(1)