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Compartment Psoas Block Efficacy and Safety

Primary Purpose

Femur Fracture

Status
Completed
Phase
Not Applicable
Locations
Ukraine
Study Type
Interventional
Intervention
Bupivacaine Hydrochloride
Sponsored by
Bogomolets National Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femur Fracture focused on measuring сompartment psoas block, femur fracture.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-proximal femur fracture

Exclusion Criteria:

  • 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).

Sites / Locations

  • Bogomolets NMU

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Group 1

Group 2

Group 3

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

ICU length of stay and the total duration of hospitalization
ICU length of stay and the total duration of hospitalization
number of patients who had severe pain after surgery
number of patients who had severe pain after surgery
incidence of on-demand analgesia
incidence of on-demand analgesia

Full Information

First Posted
September 21, 2020
Last Updated
November 23, 2020
Sponsor
Bogomolets National Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04648332
Brief Title
Compartment Psoas Block Efficacy and Safety
Official Title
Compartment Psoas Block Efficacy and Safety for Perioperative Analgesia in the Elderly With Proximal Femur Fractures: a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bogomolets National Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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
Detailed Description
A randomized controlled trial was conducted from January 2018 to August 2019 at the Into-Sana Medical Center (Odessa, Ukraine). The study design was approved by the Ethical Committee at Bogomolets National Medical University. Patients who planned osteosynthesis of the proximal femur and who met the inclusion criteria were randomized to 3 study groupsThe aim of our study was to compare the effectiveness and safety of different techniques of perioperative anaesthesia and anaesthesia in patients with fractures of the proximal femur: general anaesthesia and systemic analgesia, neuraxial (spinal) anaesthesia, compartment psoas block in combination with a sciatic nerve block. 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 anesthesia 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 with prolonged lumbar plexus block with bupivacaine 0.125% 6-8 ml / h. Patients in group 2 underwent intraoperative spinal anaesthesia at the level of L3-L4 with hyperbaric bupivacaine 10-15 mg. Patients in groups 1 - 2 receive intraoperative sedation with propofol 1% with a target level of sedation RASS from 0 to -2. Group 3 patients underwent general sevoflurane inhalation anaesthesia with fentanyl infusion for analgesia. All patients received paracetamol 3g/day and dexketoprofen 75 mg/day during hospitalization. On-demand, nalbuphine 5 mg SC was used for analgesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femur Fracture
Keywords
сompartment psoas block, femur fracture.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2
Arm Type
No Intervention
Arm Description
Patients in group 2 underwent intraoperative spinal anaesthesia at the level of L3-L4 with hyperbaric bupivacaine at a dose of 10-15 mg.
Arm Title
Group 3
Arm Type
No Intervention
Arm Description
Group 3 patients underwent general inhalation anaesthesia with sevoflurane with a constant infusion of fentanyl for analgesia.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride
Other Intervention Name(s)
regional anesthesia, compartment psoas block
Intervention Description
compartment psoas block
Primary Outcome Measure Information:
Title
postoperative nalbuphine consumption during first 24 hours and cumulative during hospital stay
Description
postoperative nalbuphine consumption during first 24 hours and cumulative during hospital stay
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
ICU length of stay and the total duration of hospitalization
Description
ICU length of stay and the total duration of hospitalization
Time Frame
102 hours
Title
number of patients who had severe pain after surgery
Description
number of patients who had severe pain after surgery
Time Frame
72 hours
Title
incidence of on-demand analgesia
Description
incidence of on-demand analgesia
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: -proximal femur fracture Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iurii Kuchyn, PhD
Organizational Affiliation
Bogomolets National Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Bogomolets NMU
City
Kyiv
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21484361
Citation
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.
Results Reference
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PubMed Identifier
30377550
Citation
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.
Results Reference
background
PubMed Identifier
23901277
Citation
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.
Results Reference
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PubMed Identifier
24763888
Citation
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.
Results Reference
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PubMed Identifier
28444280
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
26940645
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
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Citation
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Results Reference
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Compartment Psoas Block Efficacy and Safety

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