Transmuscular Quadratus Lumborum Block Plus Pericapsular Injection vs Pericapsular Injection

Phase 4

Completed

• Conditions: Hip Pain Chronic
• Interventions: Procedure: Transmuscular Quadratus Lumborum Block; Procedure: Pericapsular injection; Drug: Bupivacaine Hydrochloride

• Registration Number: NCT04353414
• Lead Sponsor: NYU Langone Health

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.

Study Timeline

• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-04-17
• Study First Posted: 2020-04-20
• Study Start: 2020-08-01
• Status Verified: 2022-02
• Primary Completion: 2022-02-17
• Study Completion: 2022-02-23
• Last Update Submitted: 2022-02-25
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transmuscular QL Block + Pericapsular Injection (PCI) group	Transmuscular Quadratus Lumborum Block	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.
Pericapsular Injection (PCI) group	Pericapsular injection	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.
Transmuscular QL Block + Pericapsular Injection (PCI) group	Pericapsular injection	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.
Pericapsular Injection (PCI) group	Bupivacaine Hydrochloride	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.
Transmuscular QL Block + Pericapsular Injection (PCI) group	Bupivacaine Hydrochloride	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.

Primary Outcome Measures

Name	Time	Method
Comparison of post-operative pain as per the Visual Analogue Scale (VAS)	1 Day of surgery	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).
Comparison of post-operative pain as per the McGill pain scores	1 Day of surgery	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.

Secondary Outcome Measures

Name	Time	Method
Comparison in Post-Anesthesia Care Unit (PACU) Phase 1 recovery time by treatment group	1 Day of surgery	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.
Use of Opioids by participants	1 Day of surgery	This will be assessed by the pain medications given to the participants depending on their pain level.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States