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Regional Anesthesia MorbidityPENG+LFCN-FICBNCT05916209

PENG and LFCN Block Versus FIC Block for Multimodal Analgesia After Total Hip Replacement Surgery: a Retrospective Analysis

An observational study of Regional Anesthesia Morbidity and Arthropathy of Hip, run by Ospedale Edoardo Bassini at 1 site in Italy.

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

Background: Optimal pain control with limited muscle weakness is paramount for a swift initiation of physical therapy and ambulation. Fascia iliaca compartment block (FICB) has been recommended since it offers the best pain control with low risk of motor block. Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
Peripheral nerve blocks
Type of treatment
Surgery or procedure
How many people
60 participants
Where
1 siteItaly
Study dates
1 Feb 2023to 1 Mar 2023
Phase
Observational
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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: primary hip replacement surgery

Who may be able to join

  • elective total hip replacement surgery for non-traumatic hip disease, age >18 years, complete clinical chart included the type of peripheral nerve block performed, signed consent form for spinal anesthesia and peripheral nerve block.

Who cannot join

  • incomplete chart, a peripheral nerve block other than PENG or FIC block was performed

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Ospedale Edoardo Bassini

    Cinisello Balsamo, Milano, 20092

Other trials in Italy

About this study

Official title: Pericapsular Nerve Group (PENG) Block and Lateral Femoral Cutaneous Nerve (LFCN) Block Versus Fascia Iliaca (FIC) Block for Multimodal Analgesia After Total Hip Replacement Surgery: a Retrospective Analysis

Background: Optimal pain control with limited muscle weakness is paramount for a swift initiation of physical therapy and ambulation. Fascia iliaca compartment block (FICB) has been recommended since it offers the best pain control with low risk of motor block. Pericapsular nerve group block (PENG) with lateral femoral cutaneous nerve (LFCN) block has been proposed as an effective alternative to FICB that offers similar pain control with a considerably lower risk of motor block. This study aimed to compare the afore mentioned blocks and determine which one yielded the lowest NRS score.

Read the detailed description

This single-center, retrospective investigation was conducted at ASST Nord Milano Bassini hospital. The study was approved by the ethics committee "Comitato Etico Milano Area 3". The main outcome of the study was the comparison of postoperative pain at 6, 12 and 24 hours, expressed as NRS (numeric rating scale), between PENG and LCFN . Secondary outcomes included total opioid consumption expressed as milligrams of morphine equivalents (MME), time to first opioid request, time to first postoperative ambulation.

Being tested
Peripheral nerve blocks
Keywords
total hip replacement surgery, primary hip arthritis

What participants receive

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

  • Peripheral nerve blocksProcedure or surgery

    Peripheral nerve blocks provide intense, site-specific analgesia administring local anesthetics near the nerves.

Study groups in NCT05916209
Study groupRoleWhat they receive
PENG + LFCN Blockgroup in which PENG + LFCN Block was performed
Receives: Procedure: Peripheral nerve blocks
FIC Blockgroup in which FIC Block was performed
Receives: Procedure: Peripheral nerve blocks

What is being measured

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

  1. pain control

    pain assessment with Numeric Rating Scale (NRS): a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

    Measured: 6 hours after surgery

  2. pain control

    pain assessment with Numeric Rating Scale (NRS): a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

    Measured: 12 hours after surgery

  3. pain control

    pain assessment with Numeric Rating Scale (NRS): a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

    Measured: 24 hours after surgery

Secondary outcomes (3)

  1. MME of PRN opioid doses

    we studied the effect of Regional anesthesia on opioid-sparing

    Measured: 6 hours after surgery

  2. MME of PRN opioid doses

    we studied the effect of Regional anesthesia on opioid-sparing

    Measured: 12 hours after surgery

  3. Morphine Milligram Equivalents (MME) of "pro re nata" (PRN) opioid doses

    we studied the effect of Regional anesthesia on opioid-sparing

    Measured: 24 hours after surgery

Timeline

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

  1. First posted23 Jun 2023
  2. Study start1 Feb 2023
  3. Primary completion1 Mar 2023
  4. Study completion1 Mar 2023

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05916209
Sponsor's protocol ID
044.677
Acronym
PENG+LFCN-FICB
Status last verified
Jun 2023
First submitted
19 May 2023
Last updated
23 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Memtsoudis SG, Cozowicz C, Bekeris J, Bekere D, Liu J, Soffin EM, Mariano ER, Johnson RL, Hargett MJ, Lee BH, Wendel P, Brouillette M, Go G, Kim SJ, Baaklini L, Wetmore D, Hong G, Goto R, Jivanelli B, Argyra E, Barrington MJ, Borgeat A, De Andres J, Elkassabany NM, Gautier PE, Gerner P, Gonzalez Della Valle A, Goytizolo E, Kessler P, Kopp SL, Lavand'Homme P, MacLean CH, Mantilla CB, MacIsaac D, McLawhorn A, Neal JM, Parks M, Parvizi J, Pichler L, Poeran J, Poultsides LA, Sites BD, Stundner O, Sun EC, Viscusi ER, Votta-Velis EG, Wu CL, Ya Deau JT, Sharrock NE. Anaesthetic care of patients undergoing primary hip and knee arthroplasty: consensus recommendations from the International Consensus on Anaesthesia-Related Outcomes after Surgery group (ICAROS) based on a systematic review and meta-analysis. Br J Anaesth. 2019 Sep;123(3):269-287. doi: 10.1016/j.bja.2019.05.042. Epub 2019 Jul 24.

    PubMed 31351590

  • Anger M, Valovska T, Beloeil H, Lirk P, Joshi GP, Van de Velde M, Raeder J; PROSPECT Working Group* and the European Society of Regional Anaesthesia and Pain Therapy. PROSPECT guideline for total hip arthroplasty: a systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2021 Aug;76(8):1082-1097. doi: 10.1111/anae.15498. Epub 2021 May 20.

    PubMed 34015859

  • Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017.

    PubMed 29026331

  • Joshi GP, Kehlet H. Postoperative pain management in the era of ERAS: An overview. Best Pract Res Clin Anaesthesiol. 2019 Sep;33(3):259-267. doi: 10.1016/j.bpa.2019.07.016. Epub 2019 Jul 25.

    PubMed 31785712

  • Shelton C, White S. Anaesthesia for hip fracture repair. BJA Educ. 2020 May;20(5):142-149. doi: 10.1016/j.bjae.2020.02.003. Epub 2020 Mar 23. No abstract available.

    PubMed 33456943

  • Chuan A, Zhao L, Tillekeratne N, Alani S, Middleton PM, Harris IA, McEvoy L, Ni Chroinin D. The effect of a multidisciplinary care bundle on the incidence of delirium after hip fracture surgery: a quality improvement study. Anaesthesia. 2020 Jan;75(1):63-71. doi: 10.1111/anae.14840. Epub 2019 Sep 23.

    PubMed 31549413

  • Peters CL, Shirley B, Erickson J. The effect of a new multimodal perioperative anesthetic regimen on postoperative pain, side effects, rehabilitation, and length of hospital stay after total joint arthroplasty. J Arthroplasty. 2006 Sep;21(6 Suppl 2):132-8. doi: 10.1016/j.arth.2006.04.017.

    PubMed 16950075

  • Costa-Martins I, Carreteiro J, Santos A, Costa-Martins M, Artilheiro V, Duque S, Campos L, Chedas M. Post-operative delirium in older hip fracture patients: a new onset or was it already there? Eur Geriatr Med. 2021 Aug;12(4):777-785. doi: 10.1007/s41999-021-00456-w. Epub 2021 Feb 11.

    PubMed 33569717

  • Steiner LA. Postoperative delirium. Part 1: pathophysiology and risk factors. Eur J Anaesthesiol. 2011 Sep;28(9):628-36. doi: 10.1097/EJA.0b013e328349b7f5.

    PubMed 21785356

  • Tsinaslanidis G, Tsinaslanidis P, Mahajan RH. Perioperative Pain Management in Patients Undergoing Total Hip Arthroplasty: Where Do We Currently Stand? Cureus. 2020 Jul 7;12(7):e9049. doi: 10.7759/cureus.9049.

    PubMed 32782868

  • Duque M, Schnetz MP, Yates AJ Jr, Monahan A, Whitehurst S, Mahajan A, Kaynar AM. Impact of Neuraxial Versus General Anesthesia on Discharge Destination in Patients Undergoing Primary Total Hip and Total Knee Replacement. Anesth Analg. 2021 Dec 1;133(6):1379-1386. doi: 10.1213/ANE.0000000000005156.

    PubMed 34784324

  • Johnson RL, Kopp SL, Burkle CM, Duncan CM, Jacob AK, Erwin PJ, Murad MH, Mantilla CB. Neuraxial vs general anaesthesia for total hip and total knee arthroplasty: a systematic review of comparative-effectiveness research. Br J Anaesth. 2016 Feb;116(2):163-76. doi: 10.1093/bja/aev455.

    PubMed 26787787

  • O'Reilly N, Desmet M, Kearns R. Fascia iliaca compartment block. BJA Educ. 2019 Jun;19(6):191-197. doi: 10.1016/j.bjae.2019.03.001. Epub 2019 Apr 24. No abstract available.

    PubMed 33456890

  • Zhang XY, Ma JB. The efficacy of fascia iliaca compartment block for pain control after total hip arthroplasty: a meta-analysis. J Orthop Surg Res. 2019 Jan 25;14(1):33. doi: 10.1186/s13018-018-1053-1.

    PubMed 30683117

  • Gao Y, Tan H, Sun R, Zhu J. Fascia iliaca compartment block reduces pain and opioid consumption after total hip arthroplasty: A systematic review and meta-analysis. Int J Surg. 2019 May;65:70-79. doi: 10.1016/j.ijsu.2019.03.014. Epub 2019 Mar 25.

    PubMed 30922995

Questions about this trial

What is this clinical trial studying?

An observational study of Regional Anesthesia Morbidity and Arthropathy of Hip, run by Ospedale Edoardo Bassini at 1 site in Italy.

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 1 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 23 Jun 2023. 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 Italy. 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?

pain control (time frame: 6 hours after surgery). The study lists 3 primary outcomes in all. 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 NCT05916209, which also lists 39 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 23 Jun 2023.

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