Hip Pain Chronic, Pain, Postoperative
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGPeri-capsular Nerve Group (PENG)
PENG block for postoperative pain management
OTHERLumbar Plexus Block (LPB)
LPB for postoperative pain management
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* elective primary total hip arthroplasty surgery anterior approach * provided informed consent * no contraindications to medications used in providing the analgesic blocks
Exclusion criteria
* contraindications to regional anesthesia, such as an allergy to amide local anesthetics * pre-existing coagulopathy or thrombocytopenia \<100,000 * refusal of analgesic block for pain management * presence of an progressive lower extremity neurological deficit * localized or systemic infection * chronic use of high dose opioid analgesics (defined as daily use greater than 60 mg oxycodone equivalents) * pregnant * refusal of consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale (NRS) Pain Score | hour 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NRS Pain Score | hour 12 | 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. |
| Time in Minutes Until Opioid Administration | hour 24 | 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. |
| Motor Strength | hour 6 | straight leg raise at 6 hours after block placed rated on a 0-5 scale with a higher score indicating better movement |
| Distance Ambulated | hour 24 | Recorded in feet during first physical therapy |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 76 |
| 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 | 76 |
| Total | 152 |
Baseline characteristics
| Characteristic | Peri-capsular Nerve Group (PENG) | Lumbar Plexus Block (LPB) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 46 Participants | 44 Participants | 90 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 32 Participants | 62 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 74 Participants | 73 Participants | 147 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) White | 69 Participants | 71 Participants | 140 Participants |
| Region of Enrollment United States | 76 participants | 76 participants | 152 participants |
| Sex: Female, Male Female | 48 Participants | 43 Participants | 91 Participants |
| Sex: Female, Male Male | 28 Participants | 33 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 75 | 0 / 75 |
| other Total, other adverse events | 0 / 75 | 0 / 75 |
| serious Total, serious adverse events | 1 / 75 | 2 / 75 |
Outcome results
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.
Time frame: hour 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peri-capsular Nerve Group (PENG) | Numeric Rating Scale (NRS) Pain Score | 4.0 units on a scale | Standard Deviation 2.8 |
| Lumbar Plexus Block (LPB) | Numeric Rating Scale (NRS) Pain Score | 2.8 units on a scale | Standard Deviation 2.4 |
Secondary
Distance Ambulated
Recorded in feet during first physical therapy
Time frame: hour 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peri-capsular Nerve Group (PENG) | Distance Ambulated | 59.1 feet | Standard Deviation 49.6 |
| Lumbar Plexus Block (LPB) | Distance Ambulated | 43.9 feet | Standard Deviation 42.2 |
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
Time frame: hour 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peri-capsular Nerve Group (PENG) | Motor Strength | 3.5 units on a scale | Standard Deviation 1.6 |
| Lumbar Plexus Block (LPB) | Motor Strength | 2.4 units on a scale | Standard Deviation 1.3 |
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.
Time frame: hour 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peri-capsular Nerve Group (PENG) | NRS Pain Score | 5.7 units on a scale | Standard Deviation 2.2 |
| Lumbar Plexus Block (LPB) | NRS Pain Score | 4.6 units on a scale | Standard Deviation 2.2 |
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.
Time frame: hour 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peri-capsular Nerve Group (PENG) | NRS Pain Score | 6.1 units on a scale | Standard Deviation 2.4 |
| Lumbar Plexus Block (LPB) | NRS Pain Score | 5.0 units on a scale | Standard Deviation 2.5 |
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.
Time frame: hour 18
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peri-capsular Nerve Group (PENG) | NRS Pain Score | 6.0 units on a scale | Standard Deviation 2.8 |
| Lumbar Plexus Block (LPB) | NRS Pain Score | 5.3 units on a scale | Standard Deviation 2.5 |
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.
Time frame: hour 24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peri-capsular Nerve Group (PENG) | Time in Minutes Until Opioid Administration | 464.98 minutes until first dose | Standard Deviation 221.67 |
| Lumbar Plexus Block (LPB) | Time in Minutes Until Opioid Administration | 394.69 minutes until first dose | Standard Deviation 158.39 |