NCT07073209

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
352

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Jul 2025Apr 2027

First Submitted

Initial submission to the registry

June 25, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

July 10, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 18, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

1.6 years

First QC Date

June 25, 2025

Last Update Submit

August 26, 2025

Conditions

Hip Fractures

Keywords

PainAnesthesiaAnalgesiaHip FracturePeripheral nerve blockRegional Anesthesia

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (6)

  • Mean NRS Pain Scores up to 24 Hours Post-block for all Subjects

    0-24 hours post block

  • Mean NRS Pain Scores up to 24 Hours Post-block in Intracapsular Hip Fractures

    0-24 hours post block

  • Mean NRS Pain Scores up to 24 Hours Post-block in Extracapsular Hip Fractures

    0-24 hours post block

  • Number of Oral Morphine Equivalents Administered for all Subjects

    0-24 hours post block

  • Number of Oral Morphine Equivalents Administered in Intracapsular Hip Fractures

    0-24 hours post block

  • +1 more secondary outcomes

Study Arms (2)

PENG Block Administration

EXPERIMENTAL

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

Procedure: PENG Block AdministrationDrug: Bupivacaine , epinephrine Dexamethasone

Femoral Block Administration

EXPERIMENTAL

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

Procedure: Femoral Block AdministrationDrug: Bupivacaine , epinephrine Dexamethasone

Interventions

PENG Block AdministrationPROCEDURE

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.

PENG Block Administration
Femoral Block AdministrationPROCEDURE

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.

Femoral Block Administration
Bupivacaine , epinephrine DexamethasoneDRUG

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

Femoral Block AdministrationPENG Block Administration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medicine

Manhattan, New York, 10065, United States

RECRUITING

Related Publications (13)

  • 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.

    PMID: 34623788BACKGROUND

  • 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.

    PMID: 26354332BACKGROUND

  • 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.

    PMID: 26330019BACKGROUND

  • 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.

    PMID: 29278266BACKGROUND

  • 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.

    PMID: 38724271BACKGROUND

  • 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.

    PMID: 28494088BACKGROUND

  • 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.

    PMID: 33289066BACKGROUND

  • 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.

    PMID: 29508382BACKGROUND

  • 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.

    PMID: 30063657BACKGROUND

  • 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.

    PMID: 37055189BACKGROUND

  • 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.

    PMID: 31809323BACKGROUND

  • Ford I, Norrie J. Pragmatic Trials. N Engl J Med. 2016 Aug 4;375(5):454-63. doi: 10.1056/NEJMra1510059. No abstract available.

    PMID: 27518663BACKGROUND

  • 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.

    PMID: 35559657BACKGROUND

Related Links

MeSH Terms

Conditions

Hip FracturesPainAgnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Tiffany Tedore, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele Steinkamp, BSN, RN

CONTACT

212-746-2953mls9004@med.cornell.edu

Mark Abdelmassih, B.S.

CONTACT

212-746-2774maa4068@med.cornell.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2025

First Posted

July 18, 2025

Study Start

July 10, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

August 28, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)