Block, Hip Replacement, Postoperative Pain
Conditions
Brief summary
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.
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.
Interventions
OTHERPENG + LFC Block
Subjects assigned to this group will receive PENG + LFC Block
OTHERQL Block
Subjects randomized to this group will receive a QL Block
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Cumulative Opioid Consumption | 0-72 hours postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Postoperative Pain Score | 0-72 hours postoperatively | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall Hip Health | Up to 6 weeks post-operatively | 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. |
| Time to First Ambulation | From anesthesia stop time to first ambulation in minutes, assessed up to 7 days post-op. | How many minutes after anesthesia stop time patients first ambulate |
| PROMIS Mental Health | up to 6 weeks post-operatively | 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. |
| PACU Duration | surgery end to time discharged from PACU, assessed up to 6 weeks post-op | Time patient spent in PACU defined as surgery end time, to the time discharged from PACU. |
| PROMIS Physical Health | Up to 6 weeks post-operatively | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 50 |
| 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 | 51 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 9 |
| Overall Study | Unable to place assigned block | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
| Overall Study | Withdrawn by study team | 0 | 1 |
Baseline characteristics
| Characteristic | PENG + LFC Block | Total | QL Block |
|---|---|---|---|
| Age, Continuous | 62.8 years STANDARD_DEVIATION 12.7 | 64.3 years STANDARD_DEVIATION 11.4 | 65.8 years STANDARD_DEVIATION 9.77 |
| Average hip pain at rest in the last week | 43.9 units on a scale STANDARD_DEVIATION 30.3 | 44.1 units on a scale STANDARD_DEVIATION 27.8 | 44.3 units on a scale STANDARD_DEVIATION 25.4 |
| Average hip pain with movement in the last week | 67.1 units on a scale STANDARD_DEVIATION 23.7 | 66.9 units on a scale STANDARD_DEVIATION 21.3 | 66.7 units on a scale STANDARD_DEVIATION 18.9 |
| Race/Ethnicity, Customized Black, African American, or Other | 16 Participants | 25 Participants | 9 Participants |
| Race/Ethnicity, Customized Caucasian | 34 Participants | 76 Participants | 42 Participants |
| Sex: Female, Male Female | 22 Participants | 51 Participants | 29 Participants |
| Sex: Female, Male Male | 28 Participants | 50 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 51 |
| other Total, other adverse events | 30 / 50 | 28 / 51 |
| serious Total, serious adverse events | 0 / 50 | 0 / 51 |
Outcome results
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.
Time frame: 0-72 hours postoperatively
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PENG + LFC Block | Postoperative Cumulative Opioid Consumption | PACU through 36-hours post op | 62.8 morphine milligram equivalents |
| PENG + LFC Block | Postoperative Cumulative Opioid Consumption | PACU | 12.7 morphine milligram equivalents |
| PENG + LFC Block | Postoperative Cumulative Opioid Consumption | PACU through 48-hours post-op | 79.5 morphine milligram equivalents |
| PENG + LFC Block | Postoperative Cumulative Opioid Consumption | PACU through 24-hours post-op | 46.1 morphine milligram equivalents |
| PENG + LFC Block | Postoperative Cumulative Opioid Consumption | PACU through 60-hours post-op | 96.2 morphine milligram equivalents |
| PENG + LFC Block | Postoperative Cumulative Opioid Consumption | PACU to 72-hours post-op | 112.9 morphine milligram equivalents |
| PENG + LFC Block | Postoperative Cumulative Opioid Consumption | PACU through 12-hours post-op | 29.4 morphine milligram equivalents |
| QL Block | Postoperative Cumulative Opioid Consumption | PACU to 72-hours post-op | 89.5 morphine milligram equivalents |
| QL Block | Postoperative Cumulative Opioid Consumption | PACU | 9.9 morphine milligram equivalents |
| QL Block | Postoperative Cumulative Opioid Consumption | PACU through 12-hours post-op | 23.2 morphine milligram equivalents |
| QL Block | Postoperative Cumulative Opioid Consumption | PACU through 24-hours post-op | 36.4 morphine milligram equivalents |
| QL Block | Postoperative Cumulative Opioid Consumption | PACU through 36-hours post op | 49.7 morphine milligram equivalents |
| QL Block | Postoperative Cumulative Opioid Consumption | PACU through 48-hours post-op | 63.0 morphine milligram equivalents |
| QL Block | Postoperative Cumulative Opioid Consumption | PACU through 60-hours post-op | 76.3 morphine milligram equivalents |
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.
Time frame: 0-72 hours postoperatively
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PENG + LFC Block | Average Postoperative Pain Score | 24-hours post-op | 48.7 units on a scale |
| PENG + LFC Block | Average Postoperative Pain Score | 48-hours post-op | 40.4 units on a scale |
| PENG + LFC Block | Average Postoperative Pain Score | 12-hours post-op | 47.2 units on a scale |
| PENG + LFC Block | Average Postoperative Pain Score | 60-hours post-op | 38.3 units on a scale |
| PENG + LFC Block | Average Postoperative Pain Score | 36-hours post-op | 46.0 units on a scale |
| PENG + LFC Block | Average Postoperative Pain Score | 72-hours post-op | 35.3 units on a scale |
| PENG + LFC Block | Average Postoperative Pain Score | 60 minutes after PACU Arrival | 33.2 units on a scale |
| QL Block | Average Postoperative Pain Score | 72-hours post-op | 31.7 units on a scale |
| QL Block | Average Postoperative Pain Score | 60 minutes after PACU Arrival | 29.5 units on a scale |
| QL Block | Average Postoperative Pain Score | 12-hours post-op | 43.5 units on a scale |
| QL Block | Average Postoperative Pain Score | 24-hours post-op | 45.1 units on a scale |
| QL Block | Average Postoperative Pain Score | 36-hours post-op | 42.4 units on a scale |
| QL Block | Average Postoperative Pain Score | 48-hours post-op | 36.8 units on a scale |
| QL Block | Average Postoperative Pain Score | 60-hours post-op | 34.7 units on a scale |
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.
Time frame: Up to 6 weeks post-operatively
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PENG + LFC Block | Overall Hip Health | 1 week post-op | 54.3 units on a scale |
| PENG + LFC Block | Overall Hip Health | 2 weeks post-op | 62.3 units on a scale |
| PENG + LFC Block | Overall Hip Health | 6 weeks post-op | 68.9 units on a scale |
| QL Block | Overall Hip Health | 1 week post-op | 57.2 units on a scale |
| QL Block | Overall Hip Health | 2 weeks post-op | 65.3 units on a scale |
| QL Block | Overall Hip Health | 6 weeks post-op | 71.8 units on a scale |
Other Pre-specified
PACU Duration
Time patient spent in PACU defined as surgery end time, to the time discharged from PACU.
Time frame: surgery end to time discharged from PACU, assessed up to 6 weeks post-op
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PENG + LFC Block | PACU Duration | 295 minutes |
| QL Block | PACU Duration | 293 minutes |
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.
Time frame: up to 6 weeks post-operatively
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PENG + LFC Block | PROMIS Mental Health | 1 week post-op | 45.9 T scores |
| PENG + LFC Block | PROMIS Mental Health | 2 weeks post-op | 49.0 T scores |
| PENG + LFC Block | PROMIS Mental Health | 6 weeks post-op | 50.7 T scores |
| QL Block | PROMIS Mental Health | 1 week post-op | 46.2 T scores |
| QL Block | PROMIS Mental Health | 2 weeks post-op | 49.3 T scores |
| QL Block | PROMIS Mental Health | 6 weeks post-op | 51.0 T scores |
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.
Time frame: Up to 6 weeks post-operatively
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PENG + LFC Block | PROMIS Physical Health | 1 Week Post-Op | 42.6 T scores |
| PENG + LFC Block | PROMIS Physical Health | 2 Weeks Post-Op | 46.0 T scores |
| PENG + LFC Block | PROMIS Physical Health | 6 Weeks Post-Op | 48.0 T scores |
| QL Block | PROMIS Physical Health | 1 Week Post-Op | 43.0 T scores |
| QL Block | PROMIS Physical Health | 2 Weeks Post-Op | 46.4 T scores |
| QL Block | PROMIS Physical Health | 6 Weeks Post-Op | 48.3 T scores |
Other Pre-specified
Time to First Ambulation
How many minutes after anesthesia stop time patients first ambulate
Time frame: From anesthesia stop time to first ambulation in minutes, assessed up to 7 days post-op.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PENG + LFC Block | Time to First Ambulation | 500.5 minutes |
| QL Block | Time to First Ambulation | 502 minutes |