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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.
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.
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.
Surgery will begin shortly after the placement of the nerve block(s).
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PENG + LFC Block | Active Comparator | 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). |
|
| QL Block | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PENG + LFC Block | Other | Subjects assigned to this group will receive PENG + LFC Block |
| |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ellen Hay, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MUSC | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39389587 | Derived | Hay E, Kelly T, Wolf BJ, Hansen E, Brown A, Lautenschlager C, Wilson SH. Comparison of pericapsular nerve group and lateral quadratus lumborum blocks on cumulative opioid consumption after primary total hip arthroplasty: a randomized controlled trial. Reg Anesth Pain Med. 2026 Jan 5;51(1):69-75. doi: 10.1136/rapm-2024-105875. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). PENG + LFC Block: Subjects assigned to this group will receive PENG + LFC Block |
| FG001 | 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. QL Block: Subjects randomized to this group will receive a QL Block |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). PENG + LFC Block: Subjects assigned to this group will receive PENG + LFC Block |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | morphine milligram equivalents | 0-72 hours postoperatively |
|
Adverse event data was collected from the time the participant signed the consent document and was randomized, to 6 weeks post-op.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). PENG + LFC Block: Subjects assigned to this group will receive PENG + LFC Block |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Itching | Skin and subcutaneous tissue disorders | itching | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ellen Johnson | Medical University of South Carolina | 843-792-2322 | hayell@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2023 | May 9, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001733 | Bites and Stings |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
| D011183 | Postoperative Complications |
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Subjects, surgeons, and data collectors will all be blinded to the allocated group. Unblinded personnel will be the Anesthesia Attending placing the block and clinical staff assisting.
| QL Block |
| Other |
Subjects randomized to this group will receive a QL Block |
|
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 |
| Unable to place assigned block |
|
| Withdrawn by study team |
|
| BG001 | 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. QL Block: Subjects randomized to this group will receive a QL Block |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Average hip pain with movement in the last week | Before surgery, participants were asked to rate their average hip pain with movement in the past week using a Visual Analog Scale (VAS) from 0-100. A higher number means worse pain. | Mean | Standard Deviation | units on a scale |
|
| Average hip pain at rest in the last week | Before surgery, participants were asked to rate their average hip pain while at rest in the past week using a Visual Analog Scale (VAS) from 0-100. A higher number means worse pain. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. QL Block: Subjects randomized to this group will receive a QL Block |
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 0-72 hours postoperatively |
|
|
|
| Other Pre-specified | Time to First Ambulation | How many minutes after anesthesia stop time patients first ambulate | Posted | Median | Inter-Quartile Range | minutes | From anesthesia stop time to first ambulation in minutes, assessed up to 7 days post-op. |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | 95% Confidence Interval | T scores | Up to 6 weeks post-operatively |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Up to 6 weeks post-operatively |
|
|
|
| Other Pre-specified | PACU Duration | Time patient spent in PACU defined as surgery end time, to the time discharged from PACU. | Posted | Median | Inter-Quartile Range | minutes | surgery end to time discharged from PACU, assessed up to 6 weeks post-op |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | 95% Confidence Interval | T scores | up to 6 weeks post-operatively |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 30 |
| 50 |
| EG001 | 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. QL Block: Subjects randomized to this group will receive a QL Block | 0 | 51 | 0 | 51 | 28 | 51 |
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Leg Swelling | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Prolonged numbness from spinal | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Incisional Numbness | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Rash, shingles | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Post-Operative Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Lower extremity sensitivity | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| 24-hours post-op |
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| 36-hours post-op |
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| 48-hours post-op |
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| 60-hours post-op |
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| 72-hours post-op |
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| 6 Weeks Post-Op |
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| 6 weeks post-op |
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| 6 weeks post-op |
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