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PENG vs Femoral Block for Hip Fracture Analgesia

PENG vs Femoral Block for Hip Fracture, A Pragmatic Cluster-Randomized Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07073209
Enrollment
352
Registered
2025-07-18
Start date
2025-07-10
Completion date
2027-04-01
Last updated
2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Fractures

Keywords

Pain, Anesthesia, Analgesia, Hip Fracture, Peripheral nerve block, Regional Anesthesia

Brief summary

This study aims to compare the Pericapsular Nerve Group (PENG) block with femoral block for hip fracture pain. Participants presenting to the hospital with a diagnosis of hip fracture and consenting to analgesic block will receive either a PENG or femoral block. The choice of block will be dictated by a randomized monthly schedule, and all participants presenting during each four-week period will receive the designated block. A sub-group analysis will be performed to determine any difference in efficacy in participants with intracapsular versus extracapsular fractures.

Detailed description

Each year, 250,000 adults in the US and 1.6 million worldwide suffer hip fractures. Peripheral nerve blocks, including femoral blocks, administered soon after admission to patients presenting with hip fractures have been shown to produce clinically and statistically significant reductions in pain scores, opioid consumption, the incidence of confusional state, and the time to mobilization. Historically, lower extremity blocks for hip fracture pain have targeted the femoral nerve. The PENG block is a relatively novel ultrasound guided block that was first described in 2018 as an alternative to the more traditional femoral block for regional hip analgesia in hip fracture patients. The PENG block targets articular branches of the obturator nerve and accessory obturator nerve, as well as branches of the femoral nerve, the combination of which richly innervate the anterior hip capsule. In a case series of 5 patients presenting to the Emergency Department with hip fracture pain, the PENG block was demonstrated to be an effective nerve block for hip analgesia by reducing the numerical rating scale pain scores by 7 points on a 10 point scale. A larger study compared the PENG block to placebo, also in hip fracture patients presenting to the Emergency Department, and demonstrated a significant decrease of 3 in the dynamic NRS pain score at 1 and 3 hours post-block. A Cochrane review in 2017 demonstrated femoral blocks to have a 3.4 point reduction in pain scores compared to placebo. No study to date has compared the PENG block to the femoral block for acute hip fracture pain. This study aims to compare the PENG block with femoral block for acute hip fracture pain in patients upon presentation who have not undergone surgical repair. Patients presenting to the hospital with a diagnosis of hip fracture and consenting to analgesic block will receive either a PENG or femoral block. The choice of block will be dictated by a randomized monthly schedule, and all patients presenting during each four-week period will receive the designated block. The primary outcome will be the change in NRS pain score from pre-block to one-hour post-block. Secondary outcomes will include NRS pain scores and opioid consumption for 24 hours post-block. A sub-group analysis will be performed to determine any difference in efficacy in patients with intracapsular versus extracapsular fractures. This will be a pragmatic study with a multiple crossover cluster-controlled design. In this type of trial an intervention is implemented for all patients for a limited period of time and then substituted with the alternate intervention for a comparable amount of time. The order of intervention will be randomized. The repetition of the study periods, especially if conducted over a period of a year of more, has the effect of reducing time-dependent confounding from background improvements in healthcare and regression to the mean. The Hawthorne effect will be limited in this particular case because both of the interventions are already routinely and interchangeably used in our current practice for hip fracture analgesia. Research consent is usually waived in this type of trial design because the treatment received by subjects is identical to standard care and the exposure within a subject population is based only on time period rather than patient characteristics or consent. As per current standard of care, all hip fracture patients admitted Monday - Friday, 7AM - 5PM, will be offered an analgesic lower extremity peripheral nerve block. Each month of the study will be randomized to either PENG or femoral block. All patients who consent to a block during each month will receive the designated block. Data will be collected from the electronic medical record (EMR).

Interventions

PROCEDUREPENG Block Administration

Policy for the PENG block administration: 30 mL of Bupivacaine 0.25% 1:200,000 epinephrine Dexamethasone 4 mg% While these drugs are administered to participants, the intervention under evaluation is the PENG Block anesthesia technique.

PROCEDUREFemoral Block Administration

Policy for the Femoral block administration: 30 mL of Bupivacaine 0.25% 1:200,000 epinephrine Dexamethasone 4 mg While these drugs are administered to participants, the intervention under evaluation is the Femoral Block anesthesia technique.

DRUGBupivacaine , epinephrine Dexamethasone

30 mL of Bupivacaine 0.25% 1:200,000 epinephrine Dexamethasone 4 mg%

Sponsors

Weill Medical College of Cornell University
Lead SponsorOTHER
New York Presbyterian Hospital
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Single-center, cluster-randomized, crossover trial. The crossover is not at an individual level in regard to the subjects but instead will be for the institutional policy regarding the block administration. A randomized schedule will be created for the type of block administered each month.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Male or female ≥ 18 years of age. 2. ASA Classification 1-4 3. Documentation of a hip fracture diagnosis along with radiologic read indicating fracture location 4. Written, informed consent for analgesic peripheral block placement

Exclusion criteria

1. Altered mental status to the extent that it limits ability to report pain score 2. Patient or health care proxy refusal of analgesic nerve block 3. Allergy to study medications or contraindication to peripheral nerve block 4. Peri-prosthetic fracture 5. Any additional fractures in a patient with a unilateral hip fracture

Design outcomes

Primary

MeasureTime frameDescription
Mean Change in Numerical Rating Scale (NRS) Pain Score One Hour Post Block for all SubjectsBaseline, 1-hour post blockThe Numerical Rating Scale (NRS) measures the intensity of pain a subject experiences. where subjects rate their pain on a scale from zero to ten and each number corresponds to a different level of intensity. The lowest score 0 represents no pain and the highest score 10 represents the most intense feeling of pain.
Mean Change in Numerical Rating Scale (NRS) Pain Score One-Hour Post Block in Intracapsular Hip FracturesBaseline, 1-hour post blockThe Numerical Rating Scale (NRS) measures the intensity of pain a subject experiences. where subjects rate their pain on a scale from zero to ten and each number corresponds to a different level of intensity. The lowest score 0 represents no pain and the highest score 10 represents the most intense feeling of pain.
Mean Change in Numerical Rating Scale (NRS) Pain Score One-Hour Post Block in Extracapsular Hip FracturesBaseline, 1-hour post blockThe Numerical Rating Scale (NRS) measures the intensity of pain a subject experiences. where subjects rate their pain on a scale from zero to ten and each number corresponds to a different level of intensity. The lowest score 0 represents no pain and the highest score 10 represents the most intense feeling of pain.

Secondary

MeasureTime frameDescription
Mean NRS Pain Scores up to 24 Hours Post-block for all Subjects0-24 hours post blockThe Numerical Rating Scale (NRS) measures the intensity of pain a subject experiences. where subjects rate their pain on a scale from zero to ten and each number corresponds to a different level of intensity. The lowest score 0 represents no pain and the highest score 10 represents the most intense feeling of pain.
Mean NRS Pain Scores up to 24 Hours Post-block in Intracapsular Hip Fractures0-24 hours post blockThe Numerical Rating Scale (NRS) measures the intensity of pain a subject experiences. where subjects rate their pain on a scale from zero to ten and each number corresponds to a different level of intensity. The lowest score 0 represents no pain and the highest score 10 represents the most intense feeling of pain.
Mean NRS Pain Scores up to 24 Hours Post-block in Extracapsular Hip Fractures0-24 hours post blockThe Numerical Rating Scale (NRS) measures the intensity of pain a subject experiences. where subjects rate their pain on a scale from zero to ten and each number corresponds to a different level of intensity. The lowest score 0 represents no pain and the highest score 10 represents the most intense feeling of pain.
Number of Oral Morphine Equivalents Administered for all Subjects0-24 hours post blockMilligrams of oral morphine equivalent opioid consumption up to 24 hours post-block. Non-morphine opioids will be converted to an equivalent morphine dosage in milligrams for comparison across both block types. Oral morphine equivalent dosages are calculated using: Wen RY et al. A Comparison of Institutional Opioid Equianalgesia Tools: A National Study. J Palliat Med. 2022;25:1686
Number of Oral Morphine Equivalents Administered in Intracapsular Hip Fractures0-24 hours post blockMilligrams of oral morphine equivalent opioid consumption up to 24 hours post-block. Non-morphine opioids will be converted to an equivalent morphine dosage in milligrams for comparison across both block types. Oral morphine equivalent dosages are calculated using: Wen RY et al. A Comparison of Institutional Opioid Equianalgesia Tools: A National Study. J Palliat Med. 2022;25:1686
Number of Oral Morphine Equivalents Administered in Extracapsular Hip Fractures0-24 hours post blockMilligrams of oral morphine equivalent opioid consumption up to 24 hours post-block. Non-morphine opioids will be converted to an equivalent morphine dosage in milligrams for comparison across both block types. Oral morphine equivalent dosages are calculated using: Wen RY et al. A Comparison of Institutional Opioid Equianalgesia Tools: A National Study. J Palliat Med. 2022;25:1686

Countries

United States

Contacts

CONTACTMichele Steinkamp, BSN, RN
mls9004@med.cornell.edu212-746-2953
CONTACTMark Abdelmassih, B.S.
maa4068@med.cornell.edu212-746-2774
PRINCIPAL_INVESTIGATORTiffany Tedore, MD

Weill Medical College of Cornell University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026