Transmuscular Quadratus Lumborum Block Plus Pericapsular Injection vs Pericapsular Injection

Hip Pain Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04353414
• Other study ID #: 20-00058
• Status: Completed
• Phase: Phase 4
• Start date: August 1, 2020
• Est. completion date: February 23, 2022

Study information

• Verified date: February 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: February 23, 2022
• Est. primary completion date: February 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hip Pain Chronic

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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