- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07073209
- Original Trial
PENG vs Femoral Block for Hip Fracture Analgesia
PENG vs Femoral Block for Hip Fracture, A Pragmatic Cluster-Randomized Study
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michele Steinkamp, BSN, RN
- Phone Number: 212-746-2953
- Email: mls9004@med.cornell.edu
Study Contact Backup
- Name: Mark Abdelmassih, B.S.
- Phone Number: 212-746-2774
- Email: maa4068@med.cornell.edu
Study Locations
-
-
New York
-
Manhattan, New York, United States, 10065
- Recruiting
- Weill Cornell Medicine
-
Contact:
- Michele Steinkamp, R.N.
- Phone Number: +1 212 746 2953
- Email: mls9004@med.cornell.edu
-
Contact:
- Tiffany Tedore, M.D.
- Phone Number: (212) 746-2725
- Email: tft9001@med.cornell.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male or female ≥ 18 years of age.
- ASA Classification 1-4
- Documentation of a hip fracture diagnosis along with radiologic read indicating fracture location
- Written, informed consent for analgesic peripheral block placement
Exclusion Criteria:
- Altered mental status to the extent that it limits ability to report pain score
- Patient or health care proxy refusal of analgesic nerve block
- Allergy to study medications or contraindication to peripheral nerve block
- Peri-prosthetic fracture
- Any additional fractures in a patient with a unilateral hip fracture
Study Plan
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
Collaborators
Investigators
- Principal Investigator: Tiffany Tedore, MD, Weill Medical College of Cornell University
Publications and helpful links
General Publications
- Griffiths R, Babu S, Dixon P, Freeman N, Hurford D, Kelleher E, Moppett I, Ray D, Sahota O, Shields M, White S. Guideline for the management of hip fractures 2020: Guideline by the Association of Anaesthetists. Anaesthesia. 2021 Feb;76(2):225-237. doi: 10.1111/anae.15291. Epub 2020 Dec 2.
- Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
- Ford I, Norrie J. Pragmatic Trials. N Engl J Med. 2016 Aug 4;375(5):454-63. doi: 10.1056/NEJMra1510059. No abstract available.
- Scurrah A, Shiner CT, Stevens JA, Faux SG. Regional nerve blockade for early analgesic management of elderly patients with hip fracture - a narrative review. Anaesthesia. 2018 Jun;73(6):769-783. doi: 10.1111/anae.14178. Epub 2017 Dec 26.
- Sessler DI, Myles PS. Novel Clinical Trial Designs to Improve the Efficiency of Research. Anesthesiology. 2020 Jan;132(1):69-81. doi: 10.1097/ALN.0000000000002989.
- Guay J, Parker MJ, Griffiths R, Kopp S. Peripheral nerve blocks for hip fractures. Cochrane Database Syst Rev. 2017 May 11;5(5):CD001159. doi: 10.1002/14651858.CD001159.pub2.
- Riddell M, Ospina M, Holroyd-Leduc JM. Use of Femoral Nerve Blocks to Manage Hip Fracture Pain among Older Adults in the Emergency Department: A Systematic Review. CJEM. 2016 Jul;18(4):245-52. doi: 10.1017/cem.2015.94. Epub 2015 Sep 10.
- Neuman MD, Feng R, Carson JL, Gaskins LJ, Dillane D, Sessler DI, Sieber F, Magaziner J, Marcantonio ER, Mehta S, Menio D, Ayad S, Stone T, Papp S, Schwenk ES, Elkassabany N, Marshall M, Jaffe JD, Luke C, Sharma B, Azim S, Hymes RA, Chin KJ, Sheppard R, Perlman B, Sappenfield J, Hauck E, Hoeft MA, Giska M, Ranganath Y, Tedore T, Choi S, Li J, Kwofie MK, Nader A, Sanders RD, Allen BFS, Vlassakov K, Kates S, Fleisher LA, Dattilo J, Tierney A, Stephens-Shields AJ, Ellenberg SS; REGAIN Investigators. Spinal Anesthesia or General Anesthesia for Hip Surgery in Older Adults. N Engl J Med. 2021 Nov 25;385(22):2025-2035. doi: 10.1056/NEJMoa2113514. Epub 2021 Oct 9.
- Ritcey B, Pageau P, Woo MY, Perry JJ. Regional Nerve Blocks For Hip and Femoral Neck Fractures in the Emergency Department: A Systematic Review. CJEM. 2016 Jan;18(1):37-47. doi: 10.1017/cem.2015.75. Epub 2015 Sep 2.
- Lin X, Liu CW, Goh QY, Sim EY, Chan SKT, Lim ZW, Chan DXH. Pericapsular nerve group (PENG) block for early pain management of elderly patients with hip fracture: a single-center double-blind randomized controlled trial. Reg Anesth Pain Med. 2023 Nov;48(11):535-539. doi: 10.1136/rapm-2022-104117. Epub 2023 Apr 13.
- Giron-Arango L, Peng P. Pericapsular nerve group (PENG) block: what have we learned in the last 5 years? Reg Anesth Pain Med. 2025 May 6;50(5):402-409. doi: 10.1136/rapm-2024-105427.
- White SM, Altermatt F, Barry J, Ben-David B, Coburn M, Coluzzi F, Degoli M, Dillane D, Foss NB, Gelmanas A, Griffiths R, Karpetas G, Kim JH, Kluger M, Lau PW, Matot I, McBrien M, McManus S, Montoya-Pelaez LF, Moppett IK, Parker M, Porrill O, Sanders RD, Shelton C, Sieber F, Trikha A, Xuebing X. International Fragility Fracture Network Delphi consensus statement on the principles of anaesthesia for patients with hip fracture. Anaesthesia. 2018 Jul;73(7):863-874. doi: 10.1111/anae.14225. Epub 2018 Mar 6. No abstract available.
- Wen RY, Atayee RS, Edmonds KP. A Comparison of Institutional Opioid Equianalgesia Tools: A National Study. J Palliat Med. 2022 Nov;25(11):1686-1691. doi: 10.1089/jpm.2021.0678. Epub 2022 May 13.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Wounds and Injuries
- Leg Injuries
- Neurobehavioral Manifestations
- Fractures, Bone
- Femoral Fractures
- Hip Injuries
- Perceptual Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Hip Fractures
- Agnosia
- Organic Chemicals
- Anilides
- Amides
- Aniline Compounds
- Amines
- Bupivacaine
Other Study ID Numbers
- 24-07027709
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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