NCT04648332

Brief Summary

A randomized controlled trial to assess the efficacy and safety of the prolonged compartment psoas block for analgesia and anesthesia for femur surgery in the elderly

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

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

Study Start

First participant enrolled

January 1, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 1, 2020

Completed
Last Updated

December 1, 2020

Status Verified

November 1, 2020

Enrollment Period

1.7 years

First QC Date

September 21, 2020

Last Update Submit

November 23, 2020

Conditions

Femur Fracture

Keywords

сompartment psoas block, femur fracture.

Outcome Measures

Primary Outcomes (1)

  • postoperative nalbuphine consumption during first 24 hours and cumulative during hospital stay

    postoperative nalbuphine consumption during first 24 hours and cumulative during hospital stay

    72 hours

Secondary Outcomes (3)

  • ICU length of stay and the total duration of hospitalization

    102 hours

  • number of patients who had severe pain after surgery

    72 hours

  • incidence of on-demand analgesia

    72 hours

Study Arms (3)

Group 1

EXPERIMENTAL

Patients in group 1 underwent catheterization of the lumbar plexus from the posterior access on admission to the hospital and began analgesia with bupivacaine 0.125% 6-8 ml / h. Intraoperative anaesthesia was provided with a bupivacaine bolus of 0.5% 200 mg in a lumbar catheter and a sciatic nerve block with 1.5% 450 mg of lidocaine. Postoperative analgesia was provided by an elongated lumbar plexus block with bupivacaine 0.125% 6-8 ml / h.

Drug: Bupivacaine Hydrochloride

Group 2

NO INTERVENTION

Patients in group 2 underwent intraoperative spinal anaesthesia at the level of L3-L4 with hyperbaric bupivacaine at a dose of 10-15 mg.

Group 3

NO INTERVENTION

Group 3 patients underwent general inhalation anaesthesia with sevoflurane with a constant infusion of fentanyl for analgesia.

Interventions

Bupivacaine HydrochlorideDRUG

compartment psoas block

Also known as: regional anesthesia, compartment psoas block
Group 1

Eligibility Criteria

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

You may qualify if:

  • proximal femur fracture

You may not qualify if:

  • pregnancy and lactation
  • history of opiate addiction
  • traumatic brain injury
  • acute cerebrovascular accident
  • chronic heart failure (New York Heart Association Functional Classification, NYHA, class III-IV)
  • respiratory failure
  • renal failure with decreased creatinine clearance less than 30 ml / min / 1.73 m2
  • hepatic insufficiency class C according to Child-Pugh).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bogomolets NMU

Kyiv, Ukraine

Location

Related Publications (9)

  • Cheng SY, Levy AR, Lefaivre KA, Guy P, Kuramoto L, Sobolev B. Geographic trends in incidence of hip fractures: a comprehensive literature review. Osteoporos Int. 2011 Oct;22(10):2575-86. doi: 10.1007/s00198-011-1596-z. Epub 2011 Apr 12.

    PMID: 21484361BACKGROUND

  • Dixon J, Ashton F, Baker P, Charlton K, Bates C, Eardley W. Assessment and Early Management of Pain in Hip Fractures: The Impact of Paracetamol. Geriatr Orthop Surg Rehabil. 2018 Oct 25;9:2151459318806443. doi: 10.1177/2151459318806443. eCollection 2018.

    PMID: 30377550BACKGROUND

  • Zhang X, Zhou Y, Chen L, Wang Q, Ni J, Liu L, Hu C, Xu X. Anesthesia and postoperative analgesia during unilateral lower-extremity fracture surgeries using multiple injections through catheters beside the lumbar plexus or sciatic nerve. Ther Clin Risk Manag. 2013;9:299-302. doi: 10.2147/TCRM.S45053. Epub 2013 Jul 23.

    PMID: 23901277BACKGROUND

  • Demirel I, Ozer AB, Duzgol O, Bayar MK, Karakurt L, Erhan OL. Comparison of unilateral spinal anesthesia and L(1) paravertebral block combined with psoas compartment and sciatic nerve block in patients to undergo partial hip prosthesis. Eur Rev Med Pharmacol Sci. 2014;18(7):1067-72.

    PMID: 24763888BACKGROUND

  • Writing Committee for the VISION Study Investigators; Devereaux PJ, Biccard BM, Sigamani A, Xavier D, Chan MTV, Srinathan SK, Walsh M, Abraham V, Pearse R, Wang CY, Sessler DI, Kurz A, Szczeklik W, Berwanger O, Villar JC, Malaga G, Garg AX, Chow CK, Ackland G, Patel A, Borges FK, Belley-Cote EP, Duceppe E, Spence J, Tandon V, Williams C, Sapsford RJ, Polanczyk CA, Tiboni M, Alonso-Coello P, Faruqui A, Heels-Ansdell D, Lamy A, Whitlock R, LeManach Y, Roshanov PS, McGillion M, Kavsak P, McQueen MJ, Thabane L, Rodseth RN, Buse GAL, Bhandari M, Garutti I, Jacka MJ, Schunemann HJ, Cortes OL, Coriat P, Dvirnik N, Botto F, Pettit S, Jaffe AS, Guyatt GH. Association of Postoperative High-Sensitivity Troponin Levels With Myocardial Injury and 30-Day Mortality Among Patients Undergoing Noncardiac Surgery. JAMA. 2017 Apr 25;317(16):1642-1651. doi: 10.1001/jama.2017.4360.

    PMID: 28444280BACKGROUND

  • Marufu TC, White SM, Griffiths R, Moonesinghe SR, Moppett IK. Prediction of 30-day mortality after hip fracture surgery by the Nottingham Hip Fracture Score and the Surgical Outcome Risk Tool. Anaesthesia. 2016 May;71(5):515-21. doi: 10.1111/anae.13418. Epub 2016 Mar 4.

    PMID: 26940757BACKGROUND

  • White SM, Moppett IK, Griffiths R, Johansen A, Wakeman R, Boulton C, Plant F, Williams A, Pappenheim K, Majeed A, Currie CT, Grocott MP. Secondary analysis of outcomes after 11,085 hip fracture operations from the prospective UK Anaesthesia Sprint Audit of Practice (ASAP-2). Anaesthesia. 2016 May;71(5):506-14. doi: 10.1111/anae.13415. Epub 2016 Mar 4.

    PMID: 26940645BACKGROUND

  • Rowlands M, Walt GV, Bradley J, Mannings A, Armstrong S, Bedforth N, Moppett IK, Sahota O. Femoral Nerve Block Intervention in Neck of Femur Fracture (FINOF): a randomised controlled trial. BMJ Open. 2018 Apr 10;8(4):e019650. doi: 10.1136/bmjopen-2017-019650.

    PMID: 29643155BACKGROUND

  • Bielka K, Kuchyn I, Tokar I, Artemenko V, Kashchii U. Psoas compartment block efficacy and safety for perioperative analgesia in the elderly with proximal femur fractures: a randomized controlled study. BMC Anesthesiol. 2021 Oct 25;21(1):252. doi: 10.1186/s12871-021-01473-9.

    PMID: 34696733DERIVED

MeSH Terms

Conditions

Femoral Fractures

Interventions

BupivacaineAnesthesia, Conduction

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAnesthesiaAnesthesia and Analgesia

Study Officials

  • Iurii Kuchyn, PhD

    Bogomolets National Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor at the Department of OF SURGERY, ANESTHESIOLOGY AND INTENSIVE THERAPY OF POSTGRADUATE EDUCATION

Study Record Dates

First Submitted

September 21, 2020

First Posted

December 1, 2020

Study Start

January 1, 2018

Primary Completion

August 30, 2019

Study Completion

August 30, 2019

Last Updated

December 1, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

UA(1)