NCT06369948

Brief Summary

Patients undergoing hip hemiarthroplasty can benefit significantly from regional anesthesia in terms of pain management and recovery . There is a wide range of regional anesthetic techniques. The most common in this anatomical region and those with the greatest published research are fascia iliac block, lumbar plexus block, and femoral nerve block . Alternative methods include lateral femoral cutaneous nerve and selective obturator nerve infiltration blocks. Novel techniques, including local infiltration analgesia and quadratus lumborum block, have been reported. While femoral nerve and lumbar plexus blocks are two common opioid-sparing regional anesthetic procedures that are successful, they come with a risk of undesired lower limb muscle weakness . On the other hand, the fascia iliac block does not always offer sufficient pain relief following hip surgery. The important landmarks targeted on the hip joint branches from the femoral nerve and the auxiliary obturator nerve may now be identified thanks to a recent anatomical study on hip innervation . This led to the discovery of a novel localized anesthetic treatment termed pericapsular nerve group block (PENG), which blocks these nerves to target the hip's anterior capsule. The PENG block has been suggested as a successful motor-sparing block for hip hemiarthroplasty . The objective of the current study is to evaluate the efficacy of the pericapsular nerve group block (PENG) for the reduction of opioid consumption and management of postoperative pain after hip hemiarthroplasty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

March 31, 2024

Last Update Submit

December 11, 2025

Conditions

Keywords

PENG blockpain managementspinal Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Total opioid consumption post operative

    total dose of any opioid drug used for pain control postoperative

    from zero hour and at time intervals: 30 minutes, 1hour, 3 hour, 6 our., 12 hour, 24 hour, 48 hour, and 36 hour after block administration

Secondary Outcomes (6)

  • 2) a Visual Analogue Scale (VAS) ranging from zero (no pain) to 10 (severe pain) for dynamic and static pain

    at time intervals: 30 minutes, 1hour, 3 hour, 6 hour, 12 hour, 24 hour, 48 hour, and 72 hour. after block administration

  • 3) Time to first opioid use

    first 24 hour after block administration

  • 4) Ability to perform physiotherapy

    1 year

  • 5) Opioid-related side effects.

    1 year

  • 6) Total length stay of hospital

    1 year

  • +1 more secondary outcomes

Study Arms (2)

Pericapsular Nerve Group (PENG) Block (P group)

EXPERIMENTAL

Patients who will undergo elective hip hemiarthroplasty and receive the Pericapsular Nerve Group (PENG) block postoperatively.

Procedure: Pericapsular Nerve Group (PENG) BlockDrug: bupivacaine 0.5% injection

Control group (C group)

ACTIVE COMPARATOR

Patients who will undergo elective hip hemiarthroplasty without receiving a PENG block.

Procedure: elective hip hemiarthroplasty without receiving a PENG block.

Interventions

The PENG block will be performed with the patient in the supine position. A linear high-frequency ultrasound probe (GE LOGIQ/P7 ultrasound, korea/ L6-12RS probe) is initially placed in a transverse plane over the anterior inferior iliac spine (AIIS); the probe is turned slightly medial until the hyperechoic continuous shadow of the iliopubic eminence (IPE). The target will be the plane between the psoas tendon and pubic ramus. The skin puncture site will be anesthetized using lidocaine 2% after skin disinfection and draping. A 22-gauge, 100 mm echogenic needle (Spinocan, B. Braun Melsungen AG, Germany) will be inserted in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, 25 mL of the local anesthetic solution (bupivacaine 0.5%) was injected in 5 mL increments while observing for adequate fluid spread in this plane.

Pericapsular Nerve Group (PENG) Block (P group)

elective hip hemiarthroplasty without receiving a PENG block.

Control group (C group)

bupivacaine 0.5% injection

Pericapsular Nerve Group (PENG) Block (P group)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- patients 18 years old or older with ASA physical status 1-3, patients who had no contraindications for spinal anesthesia, and patients undergoing elective surgery.

You may not qualify if:

  • Patients with ASA physical status 4 or above.
  • Pre-existing anatomical or neurological deficits in the lower extremity.
  • Intolerance or allergy to local anesthetics.
  • Narcotic dependency.
  • Coagulopathy or using antiplatelet or anticoagulant medications.
  • Neuromuscular diseases.
  • Psychiatric illnesses (schizophrenia, bipolar, uncontrolled anxiety or depression).
  • Systemic infections or infections at site of injection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fayoum University Hospital

El Fayoum Qesm, Fayoum Governorate, 63514, Egypt

Location

Related Publications (20)

  • Meng Y, Deng B, Liang X, Li J, Li L, Ou J, Yu S, Tan X, Chen Y, Zhang M. Effectiveness of self-efficacy-enhancing interventions on rehabilitation following total hip replacement: a randomized controlled trial with six-month follow-up. J Orthop Surg Res. 2022 Apr 10;17(1):225. doi: 10.1186/s13018-022-03116-2.

    PMID: 35399102BACKGROUND
  • van Drongelen S, Kaldowski H, Tarhan T, Assi A, Meurer A, Stief F. Are changes in radiological leg alignment and femoral parameters after total hip replacement responsible for joint loading during gait? BMC Musculoskelet Disord. 2019 Nov 10;20(1):526. doi: 10.1186/s12891-019-2832-5.

    PMID: 31707985BACKGROUND
  • Zaballa E, Dennison E, Walker-Bone K. Function and employment after total hip replacement in older adults: A narrative review. Maturitas. 2023 Jan;167:8-16. doi: 10.1016/j.maturitas.2022.09.005. Epub 2022 Sep 14.

    PMID: 36302339BACKGROUND
  • Chen L, Chen G. The Effect of Resistance Training on the Function after Hip Replacement: A Meta-analysis of Randomized Controlled Trials. Z Orthop Unfall. 2021 Aug;159(4):383-390. doi: 10.1055/a-1154-8949. Epub 2020 Dec 9.

    PMID: 33296947BACKGROUND
  • Domingue G, Warren D, Koval KJ, Riehl JT. Complications of Hip Hemiarthroplasty. Orthopedics. 2023 Jul-Aug;46(4):e199-e209. doi: 10.3928/01477447-20230125-06. Epub 2023 Jan 30.

    PMID: 36719411BACKGROUND
  • Tsai MC, Ng YY, Chen WM, Tsai SW, Wu SC. The effects of cement fixation on survival in elderly patients with hip hemiarthroplasty: a nationwide cohort study. BMC Musculoskelet Disord. 2019 Dec 27;20(1):628. doi: 10.1186/s12891-019-3013-2.

    PMID: 31881878BACKGROUND
  • Lee C, Freeman R, Edmondson M, Rogers BA. The efficacy of tranexamic acid in hip hemiarthroplasty surgery: an observational cohort study. Injury. 2015 Oct;46(10):1978-82. doi: 10.1016/j.injury.2015.06.039. Epub 2015 Jul 6.

    PMID: 26190627BACKGROUND
  • Pala E, Trono M, Bitonti A, Lucidi G. Hip hemiarthroplasty for femur neck fractures: minimally invasive direct anterior approach versus postero-lateral approach. Eur J Orthop Surg Traumatol. 2016 May;26(4):423-7. doi: 10.1007/s00590-016-1767-x. Epub 2016 Mar 30.

    PMID: 27026091BACKGROUND
  • Spaans EA, Koenraadt KLM, Wagenmakers R, Elmans LHGJ, van den Hout JAAM, Eygendaal D, Bolder SBT. Does surgeon volume influence the outcome after hip hemiarthroplasty for displaced femoral neck fractures; early outcome, complications, and survival of 752 cases. Arch Orthop Trauma Surg. 2019 Feb;139(2):255-261. doi: 10.1007/s00402-018-3076-9. Epub 2018 Nov 27.

    PMID: 30483916BACKGROUND
  • Moore BF, Lachiewicz PF. Corrosion and adverse tissue reaction after modular unipolar hip hemiarthroplasty. Arthroplast Today. 2017 Feb 21;3(4):207-210. doi: 10.1016/j.artd.2017.01.002. eCollection 2017 Dec.

    PMID: 29204481BACKGROUND
  • Verzellotti S, Candrian C, Molina M, Filardo G, Alberio R, Grassi FA. Direct anterior versus posterolateral approach for bipolar hip hemiarthroplasty in femoral neck fractures: a prospective randomised study. Hip Int. 2020 Nov;30(6):810-817. doi: 10.1177/1120700019872117. Epub 2019 Aug 26.

    PMID: 31450987BACKGROUND
  • Short AJ, Barnett JJG, Gofeld M, Baig E, Lam K, Agur AMR, Peng PWH. Anatomic Study of Innervation of the Anterior Hip Capsule: Implication for Image-Guided Intervention. Reg Anesth Pain Med. 2018 Feb;43(2):186-192. doi: 10.1097/AAP.0000000000000701.

    PMID: 29140962BACKGROUND
  • Morrison C, Brown B, Lin DY, Jaarsma R, Kroon H. Analgesia and anesthesia using the pericapsular nerve group block in hip surgery and hip fracture: a scoping review. Reg Anesth Pain Med. 2021 Feb;46(2):169-175. doi: 10.1136/rapm-2020-101826. Epub 2020 Oct 27.

    PMID: 33109730BACKGROUND
  • Kupeli I, Yazici Kara M. Anesthesia or analgesia? New block for shoulder surgery: pericapsular nerve group block. Braz J Anesthesiol. 2022 Sep-Oct;72(5):669-672. doi: 10.1016/j.bjane.2021.05.009. Epub 2021 Jun 9.

    PMID: 34118263BACKGROUND
  • Gullupinar B, Saglam C, Unluer EE, Ayvat P, Ozturk K, Gul M, Tandon S. Effectiveness of pericapsular nerve group block with ultrasonography in patients diagnosed with hip fracture in the emergency department. Ulus Travma Acil Cerrahi Derg. 2022 Jun;28(6):832-838. doi: 10.14744/tjtes.2022.67817.

    PMID: 35652877BACKGROUND
  • Farag A, Hendi NI, Diab RA. Does pericapsular nerve group block have limited analgesia at the initial post-operative period? Systematic review and meta-analysis. J Anesth. 2023 Feb;37(1):138-153. doi: 10.1007/s00540-022-03129-5. Epub 2022 Nov 7.

    PMID: 36342537BACKGROUND
  • Wang Y, Wen H, Wang M, Lu M. The Efficiency of Ultrasound-Guided Pericapsular Nerve Group Block for Pain Management after Hip Surgery: A Meta-analysis. Pain Ther. 2023 Feb;12(1):81-92. doi: 10.1007/s40122-022-00463-0. Epub 2022 Dec 8.

    PMID: 36481969BACKGROUND
  • Mysore K, Sancheti SA, Howells SR, Ballah EE, Sutton JL, Uppal V. Postoperative analgesia with pericapsular nerve group (PENG) block for primary total hip arthroplasty: a retrospective study. Can J Anaesth. 2020 Nov;67(11):1673-1674. doi: 10.1007/s12630-020-01751-z. Epub 2020 Jul 13. No abstract available.

    PMID: 32661723BACKGROUND
  • Ueshima H, Otake H. RETRACTED: Clinical experiences of pericapsular nerve group (PENG) block for hip surgery. J Clin Anesth. 2018 Dec;51:60-61. doi: 10.1016/j.jclinane.2018.08.003. Epub 2018 Aug 8. No abstract available.

    PMID: 30096522BACKGROUND
  • Kukreja P, Uppal V, Kofskey AM, Feinstein J, Northern T, Davis C, Morgan CJ, Kalagara H. Quality of recovery after pericapsular nerve group (PENG) block for primary total hip arthroplasty under spinal anaesthesia: a randomised controlled observer-blinded trial. Br J Anaesth. 2023 Jun;130(6):773-779. doi: 10.1016/j.bja.2023.02.017. Epub 2023 Mar 22.

    PMID: 36964012BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Dental OcclusionBupivacaineInjections

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Atef Mohamed Sayed, MS.C

    Faculty of medicine, Fayoum university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Patients will be divided into two groups randomized by computer generated random numbers that will be placed in separate opaque envelopes that will be opened by study investigators just before the block.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: We will include 60 patients who will undergoe elective hip hemiarthroplasty. Patients will be divided into two groups randomized by computer generated random numbers that will be placed in separate opaque envelopes that will be opened by study investigators just before the block. Pericapsular Nerve Group (PENG) Block (P group) includes 30 patients who will receive a PENG block. Control group (C group) includes 30 patients who will not receive a PENG block.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of Anesthesiology

Study Record Dates

First Submitted

March 31, 2024

First Posted

April 17, 2024

Study Start

March 1, 2024

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

December 18, 2025

Record last verified: 2025-12

Locations