Trial Outcomes & Findings for QL vs PENG for Analgesia After Hip Arthroplasty (NCT NCT05710107)
NCT ID: NCT05710107
Last Updated: 2024-12-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
106 participants
Primary outcome timeframe
0-72 hours postoperatively
Results posted on
2024-12-20
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
53
|
|
Overall Study
COMPLETED
|
42
|
42
|
|
Overall Study
NOT COMPLETED
|
11
|
11
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
8
|
9
|
|
Overall Study
Unable to place assigned block
|
2
|
0
|
|
Overall Study
Withdrawn by study team
|
0
|
1
|
Baseline Characteristics
QL vs PENG for Analgesia After Hip Arthroplasty
Baseline characteristics by cohort
| Measure |
PENG + LFC Block
n=50 Participants
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
|
QL Block
n=51 Participants
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
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.8 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
65.8 years
STANDARD_DEVIATION 9.77 • n=7 Participants
|
64.3 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
34 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, African American, or Other
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Average hip pain with movement in the last week
|
67.1 units on a scale
STANDARD_DEVIATION 23.7 • n=5 Participants
|
66.7 units on a scale
STANDARD_DEVIATION 18.9 • n=7 Participants
|
66.9 units on a scale
STANDARD_DEVIATION 21.3 • n=5 Participants
|
|
Average hip pain at rest in the last week
|
43.9 units on a scale
STANDARD_DEVIATION 30.3 • n=5 Participants
|
44.3 units on a scale
STANDARD_DEVIATION 25.4 • n=7 Participants
|
44.1 units on a scale
STANDARD_DEVIATION 27.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: 0-72 hours postoperativelyThe 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.
Outcome measures
| Measure |
PENG + LFC Block
n=50 Participants
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
|
QL Block
n=51 Participants
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
|
|---|---|---|
|
Postoperative Cumulative Opioid Consumption
PACU
|
12.7 morphine milligram equivalents
Interval 0.0 to 29.8
|
9.9 morphine milligram equivalents
Interval 0.0 to 26.8
|
|
Postoperative Cumulative Opioid Consumption
PACU through 12-hours post-op
|
29.4 morphine milligram equivalents
Interval 12.8 to 46.0
|
23.2 morphine milligram equivalents
Interval 6.8 to 39.6
|
|
Postoperative Cumulative Opioid Consumption
PACU through 24-hours post-op
|
46.1 morphine milligram equivalents
Interval 29.6 to 62.6
|
36.4 morphine milligram equivalents
Interval 20.2 to 52.6
|
|
Postoperative Cumulative Opioid Consumption
PACU through 36-hours post op
|
62.8 morphine milligram equivalents
Interval 46.1 to 79.5
|
49.7 morphine milligram equivalents
Interval 33.4 to 66.0
|
|
Postoperative Cumulative Opioid Consumption
PACU through 48-hours post-op
|
79.5 morphine milligram equivalents
Interval 62.2 to 96.8
|
63.0 morphine milligram equivalents
Interval 46.3 to 79.7
|
|
Postoperative Cumulative Opioid Consumption
PACU through 60-hours post-op
|
96.2 morphine milligram equivalents
Interval 78.0 to 114.5
|
76.3 morphine milligram equivalents
Interval 58.8 to 93.7
|
|
Postoperative Cumulative Opioid Consumption
PACU to 72-hours post-op
|
112.9 morphine milligram equivalents
Interval 93.4 to 132.4
|
89.5 morphine milligram equivalents
Interval 71.1 to 107.9
|
SECONDARY outcome
Timeframe: 0-72 hours postoperativelyAverage 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.
Outcome measures
| Measure |
PENG + LFC Block
n=50 Participants
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
|
QL Block
n=51 Participants
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
|
|---|---|---|
|
Average Postoperative Pain Score
60 minutes after PACU Arrival
|
33.2 units on a scale
Interval 26.5 to 39.9
|
29.5 units on a scale
Interval 22.9 to 36.1
|
|
Average Postoperative Pain Score
12-hours post-op
|
47.2 units on a scale
Interval 39.2 to 55.1
|
43.5 units on a scale
Interval 36.5 to 50.6
|
|
Average Postoperative Pain Score
24-hours post-op
|
48.7 units on a scale
Interval 40.5 to 60.8
|
45.1 units on a scale
Interval 38.7 to 51.5
|
|
Average Postoperative Pain Score
36-hours post-op
|
46.0 units on a scale
Interval 38.3 to 53.8
|
42.4 units on a scale
Interval 35.7 to 49.1
|
|
Average Postoperative Pain Score
48-hours post-op
|
40.4 units on a scale
Interval 32.4 to 48.4
|
36.8 units on a scale
Interval 29.8 to 43.8
|
|
Average Postoperative Pain Score
60-hours post-op
|
38.3 units on a scale
Interval 29.5 to 47.2
|
34.7 units on a scale
Interval 27.9 to 41.5
|
|
Average Postoperative Pain Score
72-hours post-op
|
35.3 units on a scale
Interval 27.1 to 43.5
|
31.7 units on a scale
Interval 24.8 to 38.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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
Outcome measures
| Measure |
PENG + LFC Block
n=50 Participants
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
|
QL Block
n=51 Participants
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
|
|---|---|---|
|
Time to First Ambulation
|
500.5 minutes
Interval 217.0 to 3031.0
|
502 minutes
Interval 204.0 to 1628.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 6 weeks post-operativelyThe 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.
Outcome measures
| Measure |
PENG + LFC Block
n=50 Participants
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
|
QL Block
n=51 Participants
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
|
|---|---|---|
|
PROMIS Physical Health
1 Week Post-Op
|
42.6 T scores
Interval 40.4 to 44.9
|
43.0 T scores
Interval 40.7 to 45.2
|
|
PROMIS Physical Health
2 Weeks Post-Op
|
46.0 T scores
Interval 43.8 to 48.3
|
46.4 T scores
Interval 44.1 to 48.7
|
|
PROMIS Physical Health
6 Weeks Post-Op
|
48.0 T scores
Interval 45.7 to 50.2
|
48.3 T scores
Interval 46.1 to 50.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 6 weeks post-operativelyThe 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.
Outcome measures
| Measure |
PENG + LFC Block
n=50 Participants
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
|
QL Block
n=51 Participants
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
|
|---|---|---|
|
Overall Hip Health
1 week post-op
|
54.3 units on a scale
Interval 49.2 to 59.4
|
57.2 units on a scale
Interval 53.0 to 61.4
|
|
Overall Hip Health
2 weeks post-op
|
62.3 units on a scale
Interval 58.1 to 66.6
|
65.3 units on a scale
Interval 60.8 to 69.8
|
|
Overall Hip Health
6 weeks post-op
|
68.9 units on a scale
Interval 64.9 to 72.9
|
71.8 units on a scale
Interval 67.3 to 76.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: surgery end to time discharged from PACU, assessed up to 6 weeks post-opTime patient spent in PACU defined as surgery end time, to the time discharged from PACU.
Outcome measures
| Measure |
PENG + LFC Block
n=50 Participants
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
|
QL Block
n=51 Participants
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
|
|---|---|---|
|
PACU Duration
|
295 minutes
Interval 29.0 to 553.0
|
293 minutes
Interval 34.0 to 547.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 6 weeks post-operativelyThe 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.
Outcome measures
| Measure |
PENG + LFC Block
n=50 Participants
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
|
QL Block
n=51 Participants
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
|
|---|---|---|
|
PROMIS Mental Health
1 week post-op
|
45.9 T scores
Interval 43.9 to 47.9
|
46.2 T scores
Interval 44.2 to 48.3
|
|
PROMIS Mental Health
2 weeks post-op
|
49.0 T scores
Interval 47.0 to 60.0
|
49.3 T scores
Interval 47.3 to 51.3
|
|
PROMIS Mental Health
6 weeks post-op
|
50.7 T scores
Interval 48.7 to 52.8
|
51.0 T scores
Interval 49.1 to 52.9
|
Adverse Events
PENG + LFC Block
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
QL Block
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PENG + LFC Block
n=50 participants at risk
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
|
QL Block
n=51 participants at risk
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
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Itching
|
38.0%
19/50 • Number of events 19 • Adverse event data was collected from the time the participant signed the consent document and was randomized, to 6 weeks post-op.
|
43.1%
22/51 • Number of events 22 • Adverse event data was collected from the time the participant signed the consent document and was randomized, to 6 weeks post-op.
|
|
Gastrointestinal disorders
Nausea
|
28.0%
14/50 • Number of events 14 • Adverse event data was collected from the time the participant signed the consent document and was randomized, to 6 weeks post-op.
|
17.6%
9/51 • Number of events 9 • Adverse event data was collected from the time the participant signed the consent document and was randomized, to 6 weeks post-op.
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
4/50 • Number of events 4 • Adverse event data was collected from the time the participant signed the consent document and was randomized, to 6 weeks post-op.
|
2.0%
1/51 • Number of events 1 • Adverse event data was collected from the time the participant signed the consent document and was randomized, to 6 weeks post-op.
|
|
Injury, poisoning and procedural complications
Leg Swelling
|
2.0%
1/50 • Number of events 1 • Adverse event data was collected from the time the participant signed the consent document and was randomized, to 6 weeks post-op.
|
0.00%
0/51 • Adverse event data was collected from the time the participant signed the consent document and was randomized, to 6 weeks post-op.
|
|
Injury, poisoning and procedural complications
Prolonged numbness from spinal
|
0.00%
0/50 • Adverse event data was collected from the time the participant signed the consent document and was randomized, to 6 weeks post-op.
|
2.0%
1/51 • Number of events 1 • Adverse event data was collected from the time the participant signed the consent document and was randomized, to 6 weeks post-op.
|
|
Injury, poisoning and procedural complications
Incisional Numbness
|
2.0%
1/50 • Number of events 1 • Adverse event data was collected from the time the participant signed the consent document and was randomized, to 6 weeks post-op.
|
0.00%
0/51 • Adverse event data was collected from the time the participant signed the consent document and was randomized, to 6 weeks post-op.
|
|
Skin and subcutaneous tissue disorders
Rash, shingles
|
0.00%
0/50 • Adverse event data was collected from the time the participant signed the consent document and was randomized, to 6 weeks post-op.
|
2.0%
1/51 • Number of events 1 • Adverse event data was collected from the time the participant signed the consent document and was randomized, to 6 weeks post-op.
|
|
Injury, poisoning and procedural complications
Post-Operative Fall
|
0.00%
0/50 • Adverse event data was collected from the time the participant signed the consent document and was randomized, to 6 weeks post-op.
|
2.0%
1/51 • Number of events 1 • Adverse event data was collected from the time the participant signed the consent document and was randomized, to 6 weeks post-op.
|
|
Skin and subcutaneous tissue disorders
Lower extremity sensitivity
|
0.00%
0/50 • Adverse event data was collected from the time the participant signed the consent document and was randomized, to 6 weeks post-op.
|
2.0%
1/51 • Number of events 1 • Adverse event data was collected from the time the participant signed the consent document and was randomized, to 6 weeks post-op.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place