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AzTrials

Femur FractureNCT04648332

Compartment Psoas Block Efficacy and Safety

A study testing Bupivacaine Hydrochloride in people with Femur Fracture, run by Bogomolets National Medical University at 1 site in Ukraine.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Femur Fracture
What is being tested?
Bupivacaine Hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteUkraine
Study dates
1 Jan 2018to 30 Aug 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -proximal femur fracture

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Ukraine1 site

  • Bogomolets NMU

    Kyiv

Other trials in Ukraine

About this study

Official title: Compartment Psoas Block Efficacy and Safety for Perioperative Analgesia in the Elderly With Proximal Femur Fractures: a Randomized Controlled Study

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

Read the 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.

Conditions
Femur Fracture
Being tested
Bupivacaine Hydrochloride
Keywords
сompartment psoas block, femur fracture.
Medical subject headings
Femoral Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bupivacaine HydrochlorideDrug

    Also called regional anesthesia, compartment psoas block

    compartment psoas block

Study groups in NCT04648332
Study groupRoleWhat they receive
Group 1ExperimentalPatients 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.
Receives: Drug: Bupivacaine Hydrochloride
Group 2No interventionPatients in group 2 underwent intraoperative spinal anaesthesia at the level of L3-L4 with hyperbaric bupivacaine at a dose of 10-15 mg.
Group 3No interventionGroup 3 patients underwent general inhalation anaesthesia with sevoflurane with a constant infusion of fentanyl for analgesia.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 72 hours

Secondary outcomes (3)

  1. ICU length of stay and the total duration of hospitalization

    ICU length of stay and the total duration of hospitalization

    Measured: 102 hours

  2. number of patients who had severe pain after surgery

    number of patients who had severe pain after surgery

    Measured: 72 hours

  3. incidence of on-demand analgesia

    incidence of on-demand analgesia

    Measured: 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2020
  2. Study start1 Jan 2018
  3. Primary completion30 Aug 2019
  4. Study completion30 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04648332
Sponsor's protocol ID
H35LP44qr9
Status last verified
Nov 2020
First submitted
21 Sep 2020
Last updated
1 Dec 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21484361

  • 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.

    PubMed 30377550

  • 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.

    PubMed 23901277

  • 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.

    PubMed 24763888

  • 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.

    PubMed 28444280

  • 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.

    PubMed 26940757

  • 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.

    PubMed 26940645

  • 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.

    PubMed 29643155

  • 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.

    PubMed 34696733

Questions about this trial

What is this clinical trial studying?

A study testing Bupivacaine Hydrochloride in people with Femur Fracture, run by Bogomolets National Medical University at 1 site in Ukraine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

postoperative nalbuphine consumption during first 24 hours and cumulative during hospital stay (time frame: 72 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04648332, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2020.

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