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AnalgesiaPengvsFICBNCT05477641

Analgesic Comparison of PENG/LFCN to FICB for Total Hip Arthroplasty

A study testing Pericapsular Nerve Group Block with Lateral Femoral Cutaneous Nerve Block and Fascia Iliaca Compartment Block in people with Analgesia, run by SSM Health Bone and Joint Hospital at St Anthony at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study compares 2 commonly used interventions (regional pain blocks) used in hip arthroplasty for pain control. One of the interventions is newer and not widely established. Read more about this study

Who is it for?
Ages 40 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Analgesia
What is being tested?
Pericapsular Nerve Group Block with Lateral Femoral Cutaneous Nerve Block and Fascia Iliaca Compartment Block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteUnited States
Study dates
28 Jul 2022to 1 Feb 2023
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 40 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Eligibility criteria for the study were: age 40-80, Physical Status I-III, BMI less than 40 kg/m2, ability to read and speak English, able to sign their own consent form and undergoing elective primary total hip arthroplasty.

Who cannot join

  • Patients were excluded if they were chronically prescribed opioids for a condition unrelated to their surgical hip pain, were deemed Physical Status 4 or higher, had an ongoing coagulopathy, had any infection near the site of injection, had an allergy to local anesthetics, deemed to have diabetic neuropathy, deemed to have a contraindication to spinal anesthesia or were unable to report their pain scores reliably (as in severe dementia or similar).

Trial locations and contacts

1 site in 1 country.

United States1 site, 1 recruiting
  • SSM Healthcare Bone and Joint Hosptial at St Anthony

    Oklahoma City, Oklahoma, 73103

    Patrick S Myer, MSN, 405-979-7736, patrick.myer@ssmhealth.com

    Recruiting

Other trials in United States

About this study

Official title: Analgesic Comparison of Pericapsular Nerve Group (PENG) Block and Lateral Femoral Cutaneous Nerve (LFCN) Block to Fascia Iliaca Compartment Block (FICB) in Patients Undergoing Primary Total Hip Arthroplasty (THA).

This study compares 2 commonly used interventions (regional pain blocks) used in hip arthroplasty for pain control. One of the interventions is newer and not widely established.

Read the detailed description

This study will compare the FICB to the PENG/LFCN blocks. Patient reported pain scores on a verbal numeric rating scale will be utilized and recorded in the PACU and postoperatively at 3, 6, 12, 18, 24, 36 and 48 hours after patient arrival in the PACU. Additionally, opioid consumption will be converted to morphine milliequivalents and compared between groups.

Conditions
Analgesia
Being tested
Pericapsular Nerve Group Block with Lateral Femoral Cutaneous Nerve Block, Fascia Iliaca Compartment Block
Medical subject headings
Agnosia

What participants receive

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

  • Pericapsular Nerve Group Block with Lateral Femoral Cutaneous Nerve BlockProcedure or surgery

    Local anesthetic will be deposited along the lower pelvis to block 3 nerves that innervate the anterior hip capsule

  • Fascia Iliaca Compartment BlockProcedure or surgery

    Also called Suprainguinal Fascia Iliaca Block

    Local anesthetic is deposited between the fascia iliaca and the internal oblique muscle in an attempt to block 3 nerves that innervate the hip.

Study groups in NCT05477641
Study groupRoleWhat they receive
pericapsular nerve group block and lateral femoral cutaneous nerve blockActive comparatorNerve blocks
Receives: Procedure: Pericapsular Nerve Group Block with Lateral Femoral Cutaneous Nerve Block; Procedure: Fascia Iliaca Compartment Block
fascia iliaca compartment blockActive comparatorNerve block
Receives: Procedure: Pericapsular Nerve Group Block with Lateral Femoral Cutaneous Nerve Block; Procedure: Fascia Iliaca Compartment Block

What is being measured

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

  1. Verbal Numeric Pain Score Comparison of Pericapsular Nerve Group (PENG) Block and Lateral Femoral Cutaneous Nerve (LFCN) Block to Fascia Iliaca Compartment Block (FICB) in Patients Undergoing Primary Total Hip Arthroplasty (THA).

    Patient reported pain scores will be monitored and tracked and compared.

    Measured: 1 year

Timeline

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

  1. First posted28 Jul 2022
  2. Study start28 Jul 2022
  3. Primary completion1 Feb 2023 (estimated)
  4. Study completion1 Feb 2023 (estimated)

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
Model description
Randomized, single-blinded, controlled study
Masking
Single blind
Who is masked
Participant
Enrolment
105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05477641
Sponsor's protocol ID
Pro00060032
Acronym
PengvsFICB
Status last verified
Jul 2022
First submitted
27 Jan 2022
Last updated
1 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bedard NA, Elkins JM, Brown TS. Effect of COVID-19 on Hip and Knee Arthroplasty Surgical Volume in the United States. J Arthroplasty. 2020 Jul;35(7S):S45-S48. doi: 10.1016/j.arth.2020.04.060. Epub 2020 Apr 24.

    PubMed 32381441
  • Berlioz BE, Bojaxhi E. PENG Regional Block(Archived). 2024 Oct 7. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK565870/

    PubMed 33351429
  • Soffin EM, YaDeau JT. Enhanced recovery after surgery for primary hip and knee arthroplasty: a review of the evidence. Br J Anaesth. 2016 Dec;117(suppl 3):iii62-iii72. doi: 10.1093/bja/aew362.

    PubMed 27940457
  • Wainwright TW, Gill M, McDonald DA, Middleton RG, Reed M, Sahota O, Yates P, Ljungqvist O. Consensus statement for perioperative care in total hip replacement and total knee replacement surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Acta Orthop. 2020 Feb;91(1):3-19. doi: 10.1080/17453674.2019.1683790. Epub 2019 Oct 30.

    PubMed 31663402
  • Li J, Zhu H, Liao R. Enhanced recovery after surgery (ERAS) pathway for primary hip and knee arthroplasty: study protocol for a randomized controlled trial. Trials. 2019 Oct 22;20(1):599. doi: 10.1186/s13063-019-3706-8.

    PubMed 31640757
  • Kaye AD, Urman RD, Cornett EM, Hart BM, Chami A, Gayle JA, Fox CJ. Enhanced recovery pathways in orthopedic surgery. J Anaesthesiol Clin Pharmacol. 2019 Apr;35(Suppl 1):S35-S39. doi: 10.4103/joacp.JOACP_35_18.

    PubMed 31142957
  • Dalens B, Vanneuville G, Tanguy A. Comparison of the fascia iliaca compartment block with the 3-in-1 block in children. Anesth Analg. 1989 Dec;69(6):705-13.

    PubMed 2589650
  • 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
  • Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.

    PubMed 30063657
  • Pascarella G, Costa F, Del Buono R, Pulitano R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agro FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1.

    PubMed 34196965
  • Sahoo RK, Jadon A, Sharma SK, Nair AS. Pericapsular nerve group (PENG) block for hip fractures: Another weapon in the armamentarium of anesthesiologists. J Anaesthesiol Clin Pharmacol. 2021 Apr-Jun;37(2):295-296. doi: 10.4103/joacp.JOACP_295_20. Epub 2021 Jul 15. No abstract available.

    PubMed 34349384
  • Allard C, Pardo E, de la Jonquiere C, Wyniecki A, Soulier A, Faddoul A, Tsai ES, Bonnet F, Verdonk F. Comparison between femoral block and PENG block in femoral neck fractures: A cohort study. PLoS One. 2021 Jun 4;16(6):e0252716. doi: 10.1371/journal.pone.0252716. eCollection 2021.

    PubMed 34086782
  • Kukreja P, Avila A, Northern T, Dangle J, Kolli S, Kalagara H. A Retrospective Case Series of Pericapsular Nerve Group (PENG) Block for Primary Versus Revision Total Hip Arthroplasty Analgesia. Cureus. 2020 May 19;12(5):e8200. doi: 10.7759/cureus.8200.

    PubMed 32572357
  • Talawar P, Tandon S, Tripathy DK, Kaushal A. Combined pericapsular nerve group and lateral femoral cutaneous nerve blocks for surgical anaesthesia in hip arthroscopy. Indian J Anaesth. 2020 Jul;64(7):638-640. doi: 10.4103/ija.IJA_57_20. Epub 2020 Jul 1. No abstract available.

    PubMed 32792743
  • Thallaj A. Combined PENG and LFCN blocks for postoperative analgesia in hip surgery-A case report. Saudi J Anaesth. 2019 Oct-Dec;13(4):381-383. doi: 10.4103/sja.SJA_299_19.

    PubMed 31572090

Questions about this trial

What is this clinical trial studying?

A study testing Pericapsular Nerve Group Block with Lateral Femoral Cutaneous Nerve Block and Fascia Iliaca Compartment Block in people with Analgesia, run by SSM Health Bone and Joint Hospital at St Anthony at 1 site in United States.

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: status not confirmed, as of the sponsor's last update on 1 Aug 2022. 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 United States. 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?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Verbal Numeric Pain Score Comparison of Pericapsular Nerve Group (PENG) Block and Lateral Femoral Cutaneous Nerve (LFCN) Block to Fascia Iliaca Compartment Block (FICB) in Patients Undergoing Primary Total Hip Arthroplasty (THA). (time frame: 1 year). 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 NCT05477641, which also lists 16 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 Aug 2022.

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