NCT03092466

Brief Summary

Assess if the addition of an early femoral nerve block (performed within 2 hours from the admission in emergency department through a femoral nerve catheter) in the elderly patients (\> 70 years) with hip fracture, reduces the incidence of postoperative delirium assessed by CAM 3Ds test, compared to the traditional systemic pain therapy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 22, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

February 26, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 28, 2017

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2024

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

6.8 years

First QC Date

February 22, 2017

Last Update Submit

April 14, 2023

Conditions

Hip Fractures

Keywords

femoral nerve blockelderly patientcognitive impairmenthip fractureregional anesthesia

Outcome Measures

Primary Outcomes (1)

  • Incidence of delirium

    Assess if the addition of an early femoral nerve block (performed within 2 hours from the admission in emergency department) in the elderly patients (\> 70 years) with hip fracture, reduces the incidence of postoperative delirium assessed by CAM 3Ds test, compared to the traditional systemic pain therapy.

    From hospital admission to home discharge, an average of 14 days

Secondary Outcomes (4)

  • Perioperative pain

    From hospital admission to home discharge, an average of 14 days

  • Length of hospital stay (LOS)

    From hospital admission to home discharge, an average of 14 days

  • Postoperative complications

    From hospital admission to home discharge, an average of 14 days

  • Mortality at 1,3,12 months after surgery

    1,3,12 months postoperative

Study Arms (2)

femoral group

ACTIVE COMPARATOR

Group 1: placement of a femoral nerve catheter plus femoral block with 15 ml of a Ropivacaine 0,75% solution through the femoral catheter

Procedure: femoral nerve catheterDrug: femoral group

control group

PLACEBO COMPARATOR

Group 2: placement of a femoral nerve catheter plus the administration of an equivalent volume (15 ml) of a saline solution through the femoral catheter

Procedure: femoral nerve catheterDrug: control group

Interventions

femoral nerve catheterPROCEDURE

femoral block with Ropivacaine 0.75% (15 ml) in femoral catheter

control groupfemoral group
femoral groupDRUG

femoral block with Ropivacaine 0.75% (15 ml) in femoral catheter

Also known as: Ropivacaine
femoral group
control groupDRUG

infusion of saline solution (15ml) in femoral catheter

Also known as: Saline solution
control group

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients aged \>70 years with femoral neck fracture, and admission in ED from Monday to Friday (from 8.00 am to 20.00 pm)
  • American society of anesthesiologists (ASA) Physical status classification I-III
  • Signed informed consent

You may not qualify if:

  • ASA\>3
  • Contraindications to the regional anesthesia
  • Patients allergic to one or more drugs used in the study
  • Patients who are unable or refuse to provide informed consent
  • Patients who show a cognitive impairment or signs of confusion or delirium already on arrival in ED
  • Postoperative ICU admission
  • Patients with Hb \< 8 mg/dl at admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASST Gaetano Pini-CTO

Milan, Milano, 20122, Italy

RECRUITING

Related Publications (14)

  • Shiga T, Wajima Z, Ohe Y. Is operative delay associated with increased mortality of hip fracture patients? Systematic review, meta-analysis, and meta-regression. Can J Anaesth. 2008 Mar;55(3):146-54. doi: 10.1007/BF03016088.

    PMID: 18310624RESULT

  • Al-Ani AN, Samuelsson B, Tidermark J, Norling A, Ekstrom W, Cederholm T, Hedstrom M. Early operation on patients with a hip fracture improved the ability to return to independent living. A prospective study of 850 patients. J Bone Joint Surg Am. 2008 Jul;90(7):1436-42. doi: 10.2106/JBJS.G.00890.

    PMID: 18594090RESULT

  • Sircar P, Godkar D, Mahgerefteh S, Chambers K, Niranjan S, Cucco R. Morbidity and mortality among patients with hip fractures surgically repaired within and after 48 hours. Am J Ther. 2007 Nov-Dec;14(6):508-13. doi: 10.1097/01.pap.0000249906.08602.a6.

    PMID: 18090875RESULT

  • Pendleton AM, Cannada LK, Guerrero-Bejarano M. Factors affecting length of stay after isolated femoral shaft fractures. J Trauma. 2007 Mar;62(3):697-700. doi: 10.1097/01.ta.0000197656.82550.39.

    PMID: 17414350RESULT

  • el-Darzi E, Vasilakis C, Chaussalet T, Millard PH. A simulation modelling approach to evaluating length of stay, occupancy, emptiness and bed blocking in a hospital geriatric department. Health Care Manag Sci. 1998 Oct;1(2):143-9. doi: 10.1023/a:1019054921219.

    PMID: 10916593RESULT

  • Hamlet WP, Lieberman JR, Freedman EL, Dorey FJ, Fletcher A, Johnson EE. Influence of health status and the timing of surgery on mortality in hip fracture patients. Am J Orthop (Belle Mead NJ). 1997 Sep;26(9):621-7.

    PMID: 9316725RESULT

  • Ruggiero C, Bonamassa L, Pelini L, Prioletta I, Cianferotti L, Metozzi A, Benvenuti E, Brandi G, Guazzini A, Santoro GC, Mecocci P, Black D, Brandi ML. Early post-surgical cognitive dysfunction is a risk factor for mortality among hip fracture hospitalized older persons. Osteoporos Int. 2017 Feb;28(2):667-675. doi: 10.1007/s00198-016-3784-3. Epub 2016 Oct 7.

    PMID: 27717957RESULT

  • Pompei P, Foreman M, Rudberg MA, Inouye SK, Braund V, Cassel CK. Delirium in hospitalized older persons: outcomes and predictors. J Am Geriatr Soc. 1994 Aug;42(8):809-15. doi: 10.1111/j.1532-5415.1994.tb06551.x.

    PMID: 8046190RESULT

  • Morrison RS, Magaziner J, Gilbert M, Koval KJ, McLaughlin MA, Orosz G, Strauss E, Siu AL. Relationship between pain and opioid analgesics on the development of delirium following hip fracture. J Gerontol A Biol Sci Med Sci. 2003 Jan;58(1):76-81. doi: 10.1093/gerona/58.1.m76.

    PMID: 12560416RESULT

  • Marcantonio ER, Flacker JM, Wright RJ, Resnick NM. Reducing delirium after hip fracture: a randomized trial. J Am Geriatr Soc. 2001 May;49(5):516-22. doi: 10.1046/j.1532-5415.2001.49108.x.

    PMID: 11380742RESULT

  • Almeida CR, Francisco EM, Pinho-Oliveira V, Assuncao JP. Fascia iliaca block associated only with deep sedation in high-risk patients, taking P2Y12 receptor inhibitors, for intramedullary femoral fixation in intertrochanteric hip fracture: a series of 3 cases. J Clin Anesth. 2016 Dec;35:339-345. doi: 10.1016/j.jclinane.2016.08.013. Epub 2016 Oct 13.

    PMID: 27871553RESULT

  • 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: 27787895RESULT

  • Kuczmarska A, Ngo LH, Guess J, O'Connor MA, Branford-White L, Palihnich K, Gallagher J, Marcantonio ER. Detection of Delirium in Hospitalized Older General Medicine Patients: A Comparison of the 3D-CAM and CAM-ICU. J Gen Intern Med. 2016 Mar;31(3):297-303. doi: 10.1007/s11606-015-3514-0.

    PMID: 26443577RESULT

  • Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.

    PMID: 33238043DERIVED

MeSH Terms

Conditions

Hip FracturesCognitive Dysfunction

Interventions

RopivacaineControl GroupsSaline Solution

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 22, 2017

First Posted

March 28, 2017

Study Start

February 26, 2017

Primary Completion

December 23, 2023

Study Completion

December 23, 2024

Last Updated

April 18, 2023

Record last verified: 2023-04

Locations

IT(1)