NCT05477641

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 27, 2022

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 28, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

July 28, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

August 1, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

January 27, 2022

Last Update Submit

July 28, 2022

Conditions

Outcome Measures

Primary Outcomes (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.

    1 year

Study Arms (2)

pericapsular nerve group block and lateral femoral cutaneous nerve block

ACTIVE COMPARATOR

Nerve blocks

Procedure: Pericapsular Nerve Group Block with Lateral Femoral Cutaneous Nerve BlockProcedure: Fascia Iliaca Compartment Block

fascia iliaca compartment block

ACTIVE COMPARATOR

Nerve block

Procedure: Pericapsular Nerve Group Block with Lateral Femoral Cutaneous Nerve BlockProcedure: Fascia Iliaca Compartment Block

Interventions

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

fascia iliaca compartment blockpericapsular nerve group block and lateral femoral cutaneous nerve 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.

Also known as: Suprainguinal Fascia Iliaca Block
fascia iliaca compartment blockpericapsular nerve group block and lateral femoral cutaneous nerve block

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SSM Healthcare Bone and Joint Hosptial at St Anthony

Oklahoma City, Oklahoma, 73103, United States

RECRUITING

Related Publications (16)

  • 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.

    PMID: 32381441BACKGROUND
  • Berlioz BE, Bojaxhi E. PENG Regional Block(Archived). 2024 Oct 7. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK565870/

    PMID: 33351429BACKGROUND
  • 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.

    PMID: 27940457BACKGROUND
  • 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.

    PMID: 31663402BACKGROUND
  • 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.

    PMID: 31640757BACKGROUND
  • 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.

    PMID: 31142957BACKGROUND
  • 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.

    PMID: 2589650BACKGROUND
  • 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.

    PMID: 30683117BACKGROUND
  • 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.

    PMID: 30063657BACKGROUND
  • 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.

    PMID: 34196965BACKGROUND
  • 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.

    PMID: 34349384BACKGROUND
  • 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.

    PMID: 34086782BACKGROUND
  • 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.

    PMID: 32572357BACKGROUND
  • 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.

    PMID: 32792743BACKGROUND
  • 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.

    PMID: 31572090BACKGROUND
  • 17. Kim YS, Park JM, Moon YS, Han SH. Assessment of pain in the elderly: A literature review. Natl Med J India. 2017;30(4):203-207. doi:10.4103/0970-258X.218673 El-Boghdadly K, Pawa A, Chin KJ. Local anesthetic systemic toxicity: current perspectives. Local Reg Anesth. 2018;11:35-44. Published 2018 Aug 8. doi:10.2147/LRA.S15451

    BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patient will be randomized into one of the 2 groups, but will not know which group. Also, the insertion site for both techniques is similar, so they won't be able to tell which group form that evidence either.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, single-blinded, controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief CRNA SSM Bone and Joint Hospital

Study Record Dates

First Submitted

January 27, 2022

First Posted

July 28, 2022

Study Start

July 28, 2022

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

August 1, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations