PENG vs Femoral Block for Hip Fracture Analgesia

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

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.

Study Overview

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).

Study Type

Interventional

Enrollment (Estimated)

352

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PENG Block Administration
Policy for the administration of the PENG block as per clinical guidelines to all subjects presenting to the hospital with a diagnosis of hip fracture and consenting to analgesic block

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.

30 mL of Bupivacaine 0.25% 1:200,000 epinephrine Dexamethasone 4 mg%
Experimental: Femoral Block Administration
Policy for the administration of the Femoral block as per clinical guidelines to all subjects presenting to the hospital with a diagnosis of hip fracture and consenting to analgesic block
30 mL of Bupivacaine 0.25% 1:200,000 epinephrine Dexamethasone 4 mg%

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in Numerical Rating Scale (NRS) Pain Score One Hour Post Block for all Subjects
Time Frame: Baseline, 1-hour post block
The 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.
Baseline, 1-hour post block
Mean Change in Numerical Rating Scale (NRS) Pain Score One-Hour Post Block in Intracapsular Hip Fractures
Time Frame: Baseline, 1-hour post block
The 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.
Baseline, 1-hour post block
Mean Change in Numerical Rating Scale (NRS) Pain Score One-Hour Post Block in Extracapsular Hip Fractures
Time Frame: Baseline, 1-hour post block
The 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.
Baseline, 1-hour post block

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean NRS Pain Scores up to 24 Hours Post-block for all Subjects
Time Frame: 0-24 hours post block
The 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.
0-24 hours post block
Mean NRS Pain Scores up to 24 Hours Post-block in Intracapsular Hip Fractures
Time Frame: 0-24 hours post block
The 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.
0-24 hours post block
Mean NRS Pain Scores up to 24 Hours Post-block in Extracapsular Hip Fractures
Time Frame: 0-24 hours post block
The 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.
0-24 hours post block
Number of Oral Morphine Equivalents Administered for all Subjects
Time Frame: 0-24 hours post block

Milligrams 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

0-24 hours post block
Number of Oral Morphine Equivalents Administered in Intracapsular Hip Fractures
Time Frame: 0-24 hours post block

Milligrams 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

0-24 hours post block
Number of Oral Morphine Equivalents Administered in Extracapsular Hip Fractures
Time Frame: 0-24 hours post block

Milligrams 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

0-24 hours post block

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Tiffany Tedore, MD, Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

June 25, 2025

First Submitted That Met QC Criteria

July 17, 2025

First Posted (Actual)

July 18, 2025

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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