QL vs PENG for Analgesia After Hip Arthroplasty

The Impact or Quadratum Lumborum (QL) Block Versus Pericapsular Nerve Group (PENG) With Lateral Femoral Cutaneous (LFC) Nerve Blocks for Analgesia After Hip Arthroplasty: a Prospective, Randomized Clinical Trial

This study will consist of patients 18 years and older who are undergoing elective hip replacement with planned same day discharge. The patients will be randomized to receive a PENG+LFC or QL block prior to undergoing the surgery to help with postoperative pain control. The primary goal will be assessing postoperative opioid use during the first 72 hours after surgery. Secondary outcomes will include postoperative pain scores from, 0-72 hours. Additional outcomes consist of time to first ambulation, functional and mobility outcomes, PACU duration, patient satisfaction and opioid related side effects.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Hip Replacement; Block
• Intervention / Treatment: Other: PENG + LFC Block; Other: QL Block

Detailed Description

1. Patients demographic data and health information will be collected including age, height, weight, and details related to injury from the medical record. Patients will also be asked to complete a set of questionnaires detailing how they feel prior to the procedure.

2. Patients will be randomly assigned to one of two groups. Group A will receive the PENG + LFC block. Group B will receive the QL block. Patients will be sedated while receiving either block.

   If patients are assigned to the QL block, ultrasound technology will be used to identify appropriate structures on the side of the abdomen. An injection of lidocaine (numbing medication) into the skin will be inserted first for comfort. A second needle will be inserted into the side of the abdomen and a numbing medication called ropivacaine will be injected.\

   If patients are randomized to receive PENG + LFC, ultrasound technology will be used to identify appropriate structures between the hip and groin area. An injection of lidocaine (numbing medication) into the skin will be inserted first for comfort. A needle will be inserted to the appropriate location between the hip and groin, and a numbing medication called ropivacaine will be injected. This may take more than one injection in the same area.

3. Surgery will begin shortly after the placement of the nerve block(s).
4. Before being discharged from the surgery center, patients will be asked their current pain score (0-100) and the study team will provide a detailed information sheet that includes instructions for the study follow-up period. Patients will receive a text message with a link to a questionnaire at 9:00 AM, and 3:00 PM for the first three days after surgery. This questionnaire will ask them to rate their average pain at rest and while moving in a specific time period by using a visual scale from 0-100. The study will also ask questions about the pain medication taken in that same time period. At day 7, participants will receive a survey link via text message with additional questions about recovery. If they do not wish to be contacted by text message, someone from the study team will contact them by telephone at the end of the seven days and ask them to read back the information recorded on the paper data sheet provided.
5. At approximately 2-3 weeks after surgery, and again at approximately 6 weeks after surgery a study team member will contact patients either via telephone or visit patients during their post-surgical clinic visit to complete a set of questionnaires related to their recovery. Patients will also be asked to report any side effects, urgent care/emergency room visits, or any new conditions while participating in the study.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • MUSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age greater than or equal to 18 years of age
• undergoing elective hip arthroplasty with planned same day discharge

Exclusion Criteria:

• local anesthetic allergy
• subjects with a weight less than 40kg
• subjects that are unable or choose not to give informed consent
• Known preoperative substance abuse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PENG + LFC Block; The pericapsular nerve group (PENG) block is an ultrasound-guided approach, first described by Giron-Arango et al. for the blockade of the articular branches of the femoral, obturator and accessory obturator nerves that provide sensory innervation to the anterior hip capsule [5,6]. In the PENG block, a low-frequency, curvilinear probe is used to visualize the anterior inferior iliac spine, iliopsoas tendon, and iliopubic eminence. After placing a subcutaneous skin wheel with lidocaine, a blunt regional anesthesia needle is inserted using in-plane ultrasound guidance. The needle is advanced until the tip lies on the lateral and inferior margin of the iliopsoas tendon between the anterior inferior iliac spine (lateral) and iliopubic eminence (deep).	Other: PENG + LFC Block; Subjects assigned to this group will receive PENG + LFC Block
Active Comparator: QL Block; The lateral QL block is performed by injecting local anesthetic deep to the transversus abdominis aponeurosis and superficial to the fascia transversalis with direct ultrasound guidance. After completing consent, placing monitors and providing mild sedation, the patient is positioned laterally and the muscular anatomy (external oblique, internal oblique, transverse abdominis, quadratus lumborum and latissimus dorsi muscles) identified. After placing a subcutaneous skin wheel with lidocaine, a blunt regional anesthesia needle is inserted using in-plane ultrasound guidance. Local anesthetic is deposited incrementally with frequent aspiration in the anterolateral border of the quadratus lumborum muscle at the junction of the transversalis fascia, outside the anterior layer of the thoracolumbar fascia and superficial to the fascia transversalis.	Other: QL Block; Subjects randomized to this group will receive a QL Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Cumulative Opioid Consumption	The primary outcome will be postoperative cumulative opioid consumption (in IV morphine mg equivalents: IV MME) over time, from 0-72 hours postoperatively. Cumulative opioid consumption will be evaluated at PACU, and through 72 hours post-op.	0-72 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Postoperative Pain Score	Average postoperative pain score on the visual analog scale (VAS) from 0-100 from 0-72-hours post-op, including approximately 60 minutes after PACU arrival. The lower the reported pain score, the better the outcome.	0-72 hours postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Ambulation	How many minutes after anesthesia stop time patients first ambulate	From anesthesia stop time to first ambulation in minutes, assessed up to 7 days post-op.
PROMIS Physical Health	The PROMIS (Patient-Reported Outcomes Measurement Information System) Global Health Questionnaire assesses functional outcomes such by evaluating the patient's physical aspects of health using the subscale, PROMIS Physical Health, at 1 week post-op, 2 weeks post-op, and 6 weeks post-op. The physical health subscale consists of four questions with a raw score between 4 and 20 that is converted to a standardized T-score between 16.2-67.7. The population mean is 50 and SD is 10. Higher T scores represent better physical health. Values are reported as constructed T scores.	Up to 6 weeks post-operatively
Overall Hip Health	The HOOS Jr will assess overall Hip Health in participants at 1 week post-op, 2 weeks post-op, and 6 weeks post-op. HOOS-JR is scored by summing the raw response (range 0-24) and then converting it to an interval score using a table provided. The interval score ranges from 0 to 100 where 0 represents total hip disability and 100 represents perfect hip health.	Up to 6 weeks post-operatively
PACU Duration	Time patient spent in PACU defined as surgery end time, to the time discharged from PACU.	surgery end to time discharged from PACU, assessed up to 6 weeks post-op
PROMIS Mental Health	The PROMIS (Patient-Reported Outcomes Measurement Information System) Mental Health Questionnaire will assess functional outcomes such by evaluating the patient's physical aspects of health using the subscale, PROMIS Physical Health, at 1 week post-op, 2 weeks post-op, and 6 weeks post-op. The physical health subscale consists of four questions with a raw score between 4 and 20 that is converted to a standardized T-score between 21.2-67.6. The population mean is 50 and SD is 10. Higher T scores represent better mental health. Values are reported as constructed T scores.	up to 6 weeks post-operatively

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Ellen Hay, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2023
• Primary Completion (Actual): November 12, 2023
• Study Completion (Actual): November 12, 2023

Study Registration Dates

• First Submitted: January 12, 2023
• First Submitted That Met QC Criteria: January 24, 2023
• First Posted (Actual): February 2, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative
• Other Study ID Numbers: Pro00124880

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No