Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT07073209 for Hip Fractures is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
PENG vs Femoral Block for Hip Fracture Analgesia 352 Randomized
Clinical Trial NCT07073209 is an interventional study for Hip Fractures that is recruiting. It started on July 10, 2025 with plans to enroll 352 participants. Led by Weill Medical College of Cornell University, it is expected to complete by April 1, 2027. The latest data from ClinicalTrials.gov was last updated on August 28, 2025.
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 designat...Show More
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 extremi...
Show MoreOfficial Title
PENG vs Femoral Block for Hip Fracture, A Pragmatic Cluster-Randomized Study
Conditions
Hip FracturesPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- 24-07027709
NCT ID Number
Start Date (Actual)
2025-07-10
Last Update Posted
2025-08-28
Completion Date (Estimated)
2027-04
Enrollment (Estimated)
352
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Pain
Anesthesia
Analgesia
Hip Fracture
Peripheral nerve block
Regional Anesthesia
Anesthesia
Analgesia
Hip Fracture
Peripheral nerve block
Regional Anesthesia
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalPENG 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 | PENG 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. Bupivacaine , epinephrine Dexamethasone 30 mL of Bupivacaine 0.25% 1:200,000 epinephrine Dexamethasone 4 mg% |
ExperimentalFemoral 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 | Femoral 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. Bupivacaine , epinephrine Dexamethasone 30 mL of Bupivacaine 0.25% 1:200,000 epinephrine Dexamethasone 4 mg% |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Mean Change in Numerical Rating Scale (NRS) Pain Score One Hour Post Block for all Subjects | 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 | 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 | 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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Mean NRS Pain Scores up to 24 Hours Post-block for all Subjects | 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 | 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 | 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 | 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 | 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 | 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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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
- Chronic pain diagnosis on preoperative opioids
Study Central Contact
Contact: Michele Steinkamp, BSN, RN, 212-746-2953, [email protected]
Contact: Mark Abdelmassih, B.S., 212-746-2774, [email protected]
1 Study Locations in 1 Countries
New York
Weill Cornell Medicine, Manhattan, New York, 10065, United States
Tiffany Tedore, M.D., Contact, (212) 746-2725, [email protected]
Michele Steinkamp, R.N., Contact, +1 212 746 2953, [email protected]
Recruiting