A Phase 4 interventional study of Peri-capsular Nerve Group (PENG) and Lumbar Plexus Block (LPB) in Pain, Postoperative and Hip Pain Chronic, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-05-21.
Sponsored by Wake Forest University Health Sciences · Phase 4, Interventional, and Treatment
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.
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's enrollment of 154 is above the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Wake Forest University Health Sciences is the lead sponsor of 1,345 studies on the registry; 198 are open to participants now.
Of its 328 completed or terminated interventional studies of FDA-regulated products, 249 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Drug: Peri-capsular Nerve Group (PENG)
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.
Other: Lumbar Plexus Block (LPB)
PENG block for postoperative pain management
LPB for postoperative pain management
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
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
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
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
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
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
Distance Ambulated
Recorded in feet during first physical therapy
Time frame: hour 24
| Milestone | Peri-capsular Nerve Group (PENG) | Lumbar Plexus Block (LPB) |
|---|---|---|
| Started | 76 | 76 |
| Completed | 75 | 75 |
| Not completed | 1 | 1 |
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.
| units on a scale | Peri-capsular Nerve Group (PENG) | Lumbar Plexus Block (LPB) |
|---|---|---|
| Numeric Rating Scale (NRS) Pain Score | 4.0 ± 2.8 | 2.8 ± 2.4 |
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.
| units on a scale | Peri-capsular Nerve Group (PENG) | Lumbar Plexus Block (LPB) |
|---|---|---|
| NRS Pain Score | 6.1 ± 2.4 | 5.0 ± 2.5 |
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.
| units on a scale | Peri-capsular Nerve Group (PENG) | Lumbar Plexus Block (LPB) |
|---|---|---|
| NRS Pain Score | 6.0 ± 2.8 | 5.3 ± 2.5 |
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.
| units on a scale | Peri-capsular Nerve Group (PENG) | Lumbar Plexus Block (LPB) |
|---|---|---|
| NRS Pain Score | 5.7 ± 2.2 | 4.6 ± 2.2 |
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.
| minutes until first dose | Peri-capsular Nerve Group (PENG) | Lumbar Plexus Block (LPB) |
|---|---|---|
| Time in Minutes Until Opioid Administration | 464.98 ± 221.67 | 394.69 ± 158.39 |
straight leg raise at 6 hours after block placed rated on a 0-5 scale with a higher score indicating better movement
| units on a scale | Peri-capsular Nerve Group (PENG) | Lumbar Plexus Block (LPB) |
|---|---|---|
| Motor Strength | 3.5 ± 1.6 | 2.4 ± 1.3 |
Recorded in feet during first physical therapy
| feet | Peri-capsular Nerve Group (PENG) | Lumbar Plexus Block (LPB) |
|---|---|---|
| Distance Ambulated | 59.1 ± 49.6 | 43.9 ± 42.2 |
Collected over 24 hour follow up of evaluating adverse events. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Peri-capsular Nerve Group (PENG) | 0/75 (0%) | 1/75 (1.3%) | 0/75 (0%) |
| Lumbar Plexus Block (LPB) | 0/75 (0%) | 2/75 (2.7%) | 0/75 (0%) |
| Event | Peri-capsular Nerve Group (PENG) | Lumbar Plexus Block (LPB) |
|---|---|---|
| Right hip dislocationMusculoskeletal and connective tissue disorders | 1/75 | 0/75 |
| Pumonary embolismBlood and lymphatic system disorders | 0/75 | 1/75 |
| epidural spreadMusculoskeletal and connective tissue disorders | 0/75 | 1/75 |
| Age, Categorical(Participants) | Peri-capsular Nerve Group (PENG) | Lumbar Plexus Block (LPB) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 30 | 32 | 62 |
| >=65 years | 46 | 44 | 90 |
| Sex: Female, Male(Participants) | Peri-capsular Nerve Group (PENG) | Lumbar Plexus Block (LPB) | Total |
|---|---|---|---|
| Female | 48 | 43 | 91 |
| Male | 28 | 33 | 61 |
| Ethnicity (NIH/OMB)(Participants) | Peri-capsular Nerve Group (PENG) | Lumbar Plexus Block (LPB) | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 3 |
| Not Hispanic or Latino | 74 | 73 | 147 |
| Unknown or Not Reported | 0 | 2 | 2 |
| Race (NIH/OMB)(Participants) | Peri-capsular Nerve Group (PENG) | Lumbar Plexus Block (LPB) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 3 | 8 |
| White | 69 | 71 | 140 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 2 | 3 |
| Region of Enrollment(participants) | Peri-capsular Nerve Group (PENG) | Lumbar Plexus Block (LPB) | Total |
|---|---|---|---|
| United States | 76 | 76 | 152 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Wake Forest University Health Sciences →