Transmuscular Quadratus Lumborum Block Plus Pericapsular Injection vs Pericapsular Injection

NCT ID: NCT04353414

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2022-02-23

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.

Conditions

Hip Pain Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pericapsular Injection (PCI) group

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.

Group Type: ACTIVE_COMPARATOR

Pericapsular injection

Intervention Type: PROCEDURE

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.

Bupivacaine Hydrochloride

Intervention Type: DRUG

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.

Transmuscular QL Block + Pericapsular Injection (PCI) group

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.

Group Type: ACTIVE_COMPARATOR

Transmuscular Quadratus Lumborum Block

Intervention Type: PROCEDURE

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.

Pericapsular injection

Intervention Type: PROCEDURE

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.

Bupivacaine Hydrochloride

Intervention Type: DRUG

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.

Interventions

Transmuscular Quadratus Lumborum Block

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.

Intervention Type: PROCEDURE

Pericapsular injection

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.

Intervention Type: PROCEDURE

Bupivacaine Hydrochloride

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Uchenna Umeh, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Other Identifiers

20-00058

Identifier Type: -

Identifier Source: org_study_id