Transmuscular Quadratus Lumborum Block Plus Pericapsular Injection vs Pericapsular Injection

Transmuscular Quadratus Lumborum Block Plus Pericapsular Injection vs Pericapsular Injection for Patients Undergoing Primary Hip Arthroscopy

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.

Study Overview

• Status: Completed
• Conditions: Hip Pain Chronic
• Intervention / Treatment: Procedure: Pericapsular injection; Drug: Bupivacaine Hydrochloride; Procedure: Transmuscular Quadratus Lumborum Block

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.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.; Drug: 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.
Active Comparator: 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.	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.; Drug: 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.; Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of Opioids by participants	This will be assessed by the pain medications given to the participants depending on their pain level.	1 Day of surgery
Comparison in Post-Anesthesia Care Unit (PACU) Phase 1 recovery time by treatment group	This will be an observation of the time it takes the patient in the immediate post op period to transition to Phase II. Factors such as severe pain and post op nausea and vomiting may affect a patient's Phase I recovery time so the study want to compare this parameter between both treatment groups.	1 Day of surgery

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Uchenna Umeh, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): February 17, 2022
• Study Completion (Actual): February 23, 2022

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: April 17, 2020
• First Posted (Actual): April 20, 2020

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 25, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 20-00058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No