NCT04882384

Brief Summary

This will be a feasibility study to see if it feasible to perform the Pericapsular Nerve Group Block for hip fractures in the Emergency Department. In addition, we will look at the efficacy of the block in these 10 patients by measuring pain scores at pre-determine time points for 16 hours.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 8, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
Last Updated

March 21, 2022

Status Verified

March 1, 2022

Enrollment Period

9 months

First QC Date

May 8, 2021

Last Update Submit

March 18, 2022

Conditions

Hip FracturesPain, Acute

Outcome Measures

Primary Outcomes (1)

  • Pain Scores

    Visual Analog Pain Scale (VAS) from 0-10 with higher scores indicating worsening pain

    16 hours.

Study Arms (1)

Peripheral Nerve Block (PENG)

EXPERIMENTAL

Patients will receive the Pericapsular Nerve Group Block.

Procedure: Pericapsular Nerve Group Block

Interventions

Pericapsular Nerve Group BlockPROCEDURE

This will be a peripheral nerve block.

Peripheral Nerve Block (PENG)

Eligibility Criteria

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

You may qualify if:

  • \>18 years old (male or female)
  • cognitive intact patients with Isolated hip fractures (both surgical and non-surgical candidates)
  • displaced/non-displaced displaced/non-displaced sub-trochanteric
  • displaced/non-displaced intra-trochanteric
  • displaced/non-displaced femoral neck/head fractures

You may not qualify if:

  • patient refusal
  • allergy to local anesthetic
  • overlying infection at injection site
  • patients who cannot provide consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

Related Publications (22)

  • Brauer CA, Coca-Perraillon M, Cutler DM, Rosen AB. Incidence and mortality of hip fractures in the United States. JAMA. 2009 Oct 14;302(14):1573-9. doi: 10.1001/jama.2009.1462.

    PMID: 19826027BACKGROUND

  • 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

  • Ma YH, Wu J, Jia B, Xue JX, Wang TL. [Continuous fascia iliaca compartment block combined with oral analgesics for pre-operative pain control in elderly hip fracture patients]. Zhonghua Yi Xue Za Zhi. 2018 Mar 13;98(10):723-727. doi: 10.3760/cma.j.issn.0376-2491.2018.10.002. Chinese.

    PMID: 29562394BACKGROUND

  • Morrison RS, Dickman E, Hwang U, Akhtar S, Ferguson T, Huang J, Jeng CL, Nelson BP, Rosenblatt MA, Silverstein JH, Strayer RJ, Torrillo TM, Todd KH. Regional Nerve Blocks Improve Pain and Functional Outcomes in Hip Fracture: A Randomized Controlled Trial. J Am Geriatr Soc. 2016 Dec;64(12):2433-2439. doi: 10.1111/jgs.14386. Epub 2016 Oct 27.

    PMID: 27787895BACKGROUND

  • Beaudoin FL, Nagdev A, Merchant RC, Becker BM. Ultrasound-guided femoral nerve blocks in elderly patients with hip fractures. Am J Emerg Med. 2010 Jan;28(1):76-81. doi: 10.1016/j.ajem.2008.09.015.

    PMID: 20006206BACKGROUND

  • Beaudoin FL, Haran JP, Liebmann O. A comparison of ultrasound-guided three-in-one femoral nerve block versus parenteral opioids alone for analgesia in emergency department patients with hip fractures: a randomized controlled trial. Acad Emerg Med. 2013 Jun;20(6):584-91. doi: 10.1111/acem.12154.

    PMID: 23758305BACKGROUND

  • Turner AL, Stevenson MD, Cross KP. Impact of ultrasound-guided femoral nerve blocks in the pediatric emergency department. Pediatr Emerg Care. 2014 Apr;30(4):227-9. doi: 10.1097/PEC.0000000000000101.

    PMID: 24651214BACKGROUND

  • Haines L, Dickman E, Ayvazyan S, Pearl M, Wu S, Rosenblum D, Likourezos A. Ultrasound-guided fascia iliaca compartment block for hip fractures in the emergency department. J Emerg Med. 2012 Oct;43(4):692-7. doi: 10.1016/j.jemermed.2012.01.050. Epub 2012 Apr 9.

    PMID: 22494596BACKGROUND

  • 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

  • Hwang U, Richardson LD, Sonuyi TO, Morrison RS. The effect of emergency department crowding on the management of pain in older adults with hip fracture. J Am Geriatr Soc. 2006 Feb;54(2):270-5. doi: 10.1111/j.1532-5415.2005.00587.x.

    PMID: 16460378BACKGROUND

  • Orebaugh SL, Kentor ML, Williams BA. Adverse outcomes associated with nerve stimulator-guided and ultrasound-guided peripheral nerve blocks by supervised trainees: update of a single-site database. Reg Anesth Pain Med. 2012 Nov-Dec;37(6):577-82. doi: 10.1097/AAP.0b013e318263d396.

    PMID: 22996199BACKGROUND

  • Barrington MJ, Watts SA, Gledhill SR, Thomas RD, Said SA, Snyder GL, Tay VS, Jamrozik K. Preliminary results of the Australasian Regional Anaesthesia Collaboration: a prospective audit of more than 7000 peripheral nerve and plexus blocks for neurologic and other complications. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):534-41. doi: 10.1097/aap.0b013e3181ae72e8.

    PMID: 19916206BACKGROUND

  • Dochez E, van Geffen GJ, Bruhn J, Hoogerwerf N, van de Pas H, Scheffer G. Prehospital administered fascia iliaca compartment block by emergency medical service nurses, a feasibility study. Scand J Trauma Resusc Emerg Med. 2014 Jun 23;22:38. doi: 10.1186/1757-7241-22-38.

    PMID: 24957807BACKGROUND

  • Swenson JD, Davis JJ, Stream JO, Crim JR, Burks RT, Greis PE. Local anesthetic injection deep to the fascia iliaca at the level of the inguinal ligament: the pattern of distribution and effects on the obturator nerve. J Clin Anesth. 2015 Dec;27(8):652-7. doi: 10.1016/j.jclinane.2015.07.001. Epub 2015 Aug 13.

    PMID: 26277873BACKGROUND

  • Marhofer P, Nasel C, Sitzwohl C, Kapral S. Magnetic resonance imaging of the distribution of local anesthetic during the three-in-one block. Anesth Analg. 2000 Jan;90(1):119-24. doi: 10.1097/00000539-200001000-00027.

    PMID: 10624991BACKGROUND

  • Gerhardt M, Johnson K, Atkinson R, Snow B, Shaw C, Brown A, Vangsness CT Jr. Characterisation and classification of the neural anatomy in the human hip joint. Hip Int. 2012 Jan-Feb;22(1):75-81. doi: 10.5301/HIP.2012.9042.

    PMID: 22344482BACKGROUND

  • Birnbaum K, Prescher A, Hessler S, Heller KD. The sensory innervation of the hip joint--an anatomical study. Surg Radiol Anat. 1997;19(6):371-5. doi: 10.1007/BF01628504.

    PMID: 9479711BACKGROUND

  • WERTHEIMER LG. The sensory nerves of the hip joint. J Bone Joint Surg Am. 1952 Apr;34-A(2):477-87. No abstract available.

    PMID: 14917714BACKGROUND

  • GARDNER E. The innervation of the hip joint. Anat Rec. 1948 Jul;101(3):353-71. doi: 10.1002/ar.1091010309. No abstract available.

    PMID: 18873153BACKGROUND

  • Gofeld M. Pericapsular nerve group (PENG) block: an ethical and academic perspective. Reg Anesth Pain Med. 2019 May 17:rapm-2019-100456. doi: 10.1136/rapm-2019-100456. Online ahead of print. No abstract available.

    PMID: 31101728BACKGROUND

  • Acharya U, Lamsal R. Pericapsular Nerve Group Block: An Excellent Option for Analgesia for Positional Pain in Hip Fractures. Case Rep Anesthesiol. 2020 Mar 12;2020:1830136. doi: 10.1155/2020/1830136. eCollection 2020.

    PMID: 32231802BACKGROUND

  • Kukreja P, Avila A, Northern T, Dangle J, Kolli S, Kalagara H. A Retrospective Case Series of Pericapsular Nerve Group (PENG) Block for Primary Versus Revision Total Hip Arthroplasty Analgesia. Cureus. 2020 May 19;12(5):e8200. doi: 10.7759/cureus.8200.

    PMID: 32572357BACKGROUND

MeSH Terms

Conditions

Hip FracturesAcute Pain

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Halperin

    Jacobi Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Principal Investigator

Study Record Dates

First Submitted

May 8, 2021

First Posted

May 12, 2021

Study Start

July 1, 2021

Primary Completion

March 15, 2022

Study Completion

March 15, 2022

Last Updated

March 21, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)