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The purpose of this randomized, double blinded, prospective study is to compare the postoperative analgesia provided by the PENG block to that provided by the LPB for patients undergoing primary anterior approach THA.
Regional anesthesia procedures represent a common modality for postoperative analgesia after total hip arthroplasty surgeries (THA). The standard practice many years has been the Lumbar Plexus block (LPB), which anesthetizes the L1-L5 lumbar nerve roots1. While the LPB offers analgesia from the associated sensory block, it also blocks motor fibers, leading to lower extremity weakness that could potentially delay the patient's ability to participate in early physical therapy and may thereby delay discharge. In the past several years, newer regional anesthesia block approaches have been described and investigated in an attempt to provide patients with postoperative analgesia while avoiding associated muscle weakness, facilitating earlier physical therapy participation and discharge. One such nerve block is the peri-capsular nerve group (PENG) block, which anesthetizes the articular branches of the femoral, obturator, and accessory obturator nerves providing sensory innervation to the hip joint capsule without consistently causing lower extremity weakness2. Some institutions are utilizing the PENG block to provide postoperative analgesia and facilitate early mobilization. There are currently no prospective studies that directly compare the efficacy of LPB to PENG block for providing postoperative analgesia after THA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peri-capsular Nerve Group (PENG) | Experimental | Those subjects assigned to the PENG treatment arm will receive a PENG block using 20mL of 0.2% ropivacaine with 1:400,000 epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot. |
|
| Lumbar Plexus Block (LPB) | Active Comparator | Those subjects assigned to the LPB treatment arm will receive a stimulation-based LPB dosed with 20cc of 0.2% ropivacaine with 1:400,000 dilution epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peri-capsular Nerve Group (PENG) | Drug | PENG block for postoperative pain management |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating Scale (NRS) Pain Score | a comparison of patient-reported numeric rating scale (NRS) pain scores with movement at six hours following block placement. Equivalency will be defined as a difference of less than one point in either direction on the eleven-point NRS pain scale. Score ranges from 0-10 with a higher score denoting more pain. | hour 6 |
| Measure | Description | Time Frame |
|---|---|---|
| NRS Pain Score | a comparison of patient-reported numeric rating scale (NRS) pain scores with movement at 12 hours following block placement. Score ranges from 0-10 with a higher score denoting more pain. | hour 12 |
| NRS Pain Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rawad Hamzi, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Peri-capsular Nerve Group (PENG) | Those subjects assigned to the PENG treatment arm will receive a PENG block using 20mL of 0.2% ropivacaine with 1:400,000 epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot. Peri-capsular Nerve Group (PENG): PENG block for postoperative pain management |
| FG001 | Lumbar Plexus Block (LPB) | Those subjects assigned to the LPB treatment arm will receive a stimulation-based LPB dosed with 20cc of 0.2% ropivacaine with 1:400,000 dilution epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot. Lumbar Plexus Block (LPB): LPB for postoperative pain management |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Peri-capsular Nerve Group (PENG) | Those subjects assigned to the PENG treatment arm will receive a PENG block using 20mL of 0.2% ropivacaine with 1:400,000 epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot. Peri-capsular Nerve Group (PENG): PENG block for postoperative pain management |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Numeric Rating Scale (NRS) Pain Score | a comparison of patient-reported numeric rating scale (NRS) pain scores with movement at six hours following block placement. Equivalency will be defined as a difference of less than one point in either direction on the eleven-point NRS pain scale. Score ranges from 0-10 with a higher score denoting more pain. | Posted | Mean | Standard Deviation | units on a scale | hour 6 |
|
24 hour follow up of evaluating adverse events
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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 | Peri-capsular Nerve Group (PENG) | Those subjects assigned to the PENG treatment arm will receive a PENG block using 20mL of 0.2% ropivacaine with 1:400,000 epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot. Peri-capsular Nerve Group (PENG): PENG block for postoperative pain management |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Right hip dislocation | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daryl Henshaw, MD | Wake Forest School of Medicine | 336-716-4498 | dhenshaw@wakehealth.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 | Nov 17, 2023 | Jan 9, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 21, 2023 | Jan 9, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Lumbar Plexus Block (LPB) | Other | LPB for postoperative pain management |
|
a comparison of patient-reported numeric rating scale (NRS) pain scores with movement at 18 hours following block placement. Score ranges from 0-10 with a higher score denoting more pain.
| hour 18 |
| NRS Pain Score | a comparison of patient-reported numeric rating scale (NRS) pain scores with movement at 24 hours following block placement. Score ranges from 0-10 with a higher score denoting more pain. | hour 24 |
| Time in Minutes Until Opioid Administration | Time to first dose of opioid rescue for postoperative pain management - This outcome was evaluated in time to first opioid dose, which was measured in hours - no analysis for mean, median, or any of the others suggested - It was calculated as time of block to time of first opioid dose-hours and minutes. | hour 24 |
| Motor Strength | straight leg raise at 6 hours after block placed rated on a 0-5 scale with a higher score indicating better movement | hour 6 |
| Distance Ambulated | Recorded in feet during first physical therapy | hour 24 |
| Lumbar Plexus Block (LPB) |
Those subjects assigned to the LPB treatment arm will receive a stimulation-based LPB dosed with 20cc of 0.2% ropivacaine with 1:400,000 dilution epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot. Lumbar Plexus Block (LPB): LPB for postoperative pain management |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Those subjects assigned to the LPB treatment arm will receive a stimulation-based LPB dosed with 20cc of 0.2% ropivacaine with 1:400,000 dilution epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot. Lumbar Plexus Block (LPB): LPB for postoperative pain management |
|
|
| Secondary | NRS Pain Score | a comparison of patient-reported numeric rating scale (NRS) pain scores with movement at 12 hours following block placement. Score ranges from 0-10 with a higher score denoting more pain. | Posted | Mean | Standard Deviation | units on a scale | hour 12 |
|
|
|
| Secondary | NRS Pain Score | a comparison of patient-reported numeric rating scale (NRS) pain scores with movement at 18 hours following block placement. Score ranges from 0-10 with a higher score denoting more pain. | Posted | Mean | Standard Deviation | units on a scale | hour 18 |
|
|
|
| Secondary | NRS Pain Score | a comparison of patient-reported numeric rating scale (NRS) pain scores with movement at 24 hours following block placement. Score ranges from 0-10 with a higher score denoting more pain. | Posted | Mean | Standard Deviation | units on a scale | hour 24 |
|
|
|
| Secondary | Time in Minutes Until Opioid Administration | Time to first dose of opioid rescue for postoperative pain management - This outcome was evaluated in time to first opioid dose, which was measured in hours - no analysis for mean, median, or any of the others suggested - It was calculated as time of block to time of first opioid dose-hours and minutes. | The number analyzed for pain meds in each group is different from the participant flow because not everyone had to have opioids within the first 24 hours. This outcome is related to only those that required opioids in each group. | Posted | Mean | Standard Deviation | minutes until first dose | hour 24 |
|
|
|
| Secondary | Motor Strength | straight leg raise at 6 hours after block placed rated on a 0-5 scale with a higher score indicating better movement | Posted | Mean | Standard Deviation | units on a scale | hour 6 |
|
|
|
| Secondary | Distance Ambulated | Recorded in feet during first physical therapy | Posted | Mean | Standard Deviation | feet | hour 24 |
|
|
|
| 0 |
| 75 |
| 1 |
| 75 |
| 0 |
| 75 |
| EG001 | Lumbar Plexus Block (LPB) | Those subjects assigned to the LPB treatment arm will receive a stimulation-based LPB dosed with 20cc of 0.2% ropivacaine with 1:400,000 dilution epinephrine dosed in 5mL increments with negative aspiration beforehand and between each aliquot. Lumbar Plexus Block (LPB): LPB for postoperative pain management | 0 | 75 | 2 | 75 | 0 | 75 |
| Pumonary embolism | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| epidural spread | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | LP block inadvertently spread into the epidural space |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |