NCT07046052

Brief Summary

Pericapsular Nerve Group Block (PENG) is an effective regional anaesthesia modality in providing analgesia following neck of femur fracture. Continuous PENG techniques, using indwelling catheters and infusions of local anaesthetic, facilitate the continuation of analgesia for a number of days following hip fracture surgery. It is unclear from the published literature whether an optimal strategy of local anaesthetic delivery has been characterized. Similar doses of local anaesthetic agents can be administered by either continuous infusion or timed intermittent bolus. It is unclear whether one dosing strategy is superior to the other in the context of hip fracture analgesia. The study aims to evaluate the clinical efficacy of both dosing strategies in patients undergoing hip fracture surgery.

Trial Health

57
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2026

Completed
Last Updated

July 1, 2025

Status Verified

June 1, 2025

Enrollment Period

1.8 years

First QC Date

June 22, 2025

Last Update Submit

June 22, 2025

Conditions

Keywords

hip fractureregional anaesthesiaanalgesiapeng blockcontinuous infusionprogrammed intermittent bolusrandomised controlled trial

Outcome Measures

Primary Outcomes (1)

  • Numeric Rating Pain Scale (NRS 0-10)

    Patients will be invited to rate their post operative pain at rest and on movement on a 0-10 scale; where 0 is no pain and 10 is worst imaginable pain.

    48 Hours Post-operatively

Secondary Outcomes (2)

  • Numeric Rating Pain Scale (NRS 0-10)

    1, 2, 4, 24 hours postoperatively

  • Quality of Recovery 15 (QOR15)

    48 hours postoperatively

Study Arms (2)

Continuous PENG Infusion

ACTIVE COMPARATOR

Participants will be randomly assigned to this arm and will receive a continuous infusion of levobupivacaine.

Other: continuous infusion of levobupivacaine

Programmed Intermittent Bolus PENG

EXPERIMENTAL

Participants will be randomly assigned to this arm and will receive a timed pre-set bolus dose of levobupivacaine.

Other: Programmed Intermittent Bolus of Levobupivacaine

Interventions

Participants in this arm will receive a continuous infusion of levobupivacaine via a regional anaesthesia catheter placed in the PENG fascial space. The total dose over 24 hours will be equivalent in both arms of the study.

Continuous PENG Infusion

Participants in this arm will receive a timed pre-set bolus dose of levobupivacaine via a regional anaesthesia catheter placed in the PENG fascial space. The total dose over 24 hours will be equivalent in both groups.

Programmed Intermittent Bolus PENG

Eligibility Criteria

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

You may qualify if:

  • English-speaking
  • over the age of 18 years
  • hemiarthroplasty for fractured neck of femur
  • able to provide written consent.

You may not qualify if:

  • under 50kg body weight.
  • unable to provide consent due to incapacity
  • pregnant women
  • vulnerable adults under state guardianship
  • Patients with pre-existing chronic pain disorders or with a history of long-term opioid use
  • those with contraindications to a peripheral nerve block such as local site infection, allergy to local anaesthetic or those who are coagulopathic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cork University Hospital

Cork, Cork, P85 FR62, Ireland

RECRUITING

Related Publications (12)

  • Zheng J, Pan D, Zheng B, Ruan X. Preoperative pericapsular nerve group (PENG) block for total hip arthroplasty: a randomized, placebo-controlled trial. Reg Anesth Pain Med. 2022 Mar;47(3):155-160. doi: 10.1136/rapm-2021-103228. Epub 2021 Dec 6.

    PMID: 34873023BACKGROUND
  • Lin X, Liu CW, Goh QY, Sim EY, Chan SKT, Lim ZW, Chan DXH. Pericapsular nerve group (PENG) block for early pain management of elderly patients with hip fracture: a single-center double-blind randomized controlled trial. Reg Anesth Pain Med. 2023 Nov;48(11):535-539. doi: 10.1136/rapm-2022-104117. Epub 2023 Apr 13.

    PMID: 37055189BACKGROUND
  • Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.

    PMID: 23411725BACKGROUND
  • Yang L, Huang X, Cui Y, Xiao Y, Zhao X, Xu J. Combined Programmed Intermittent Bolus Infusion With Continuous Infusion for the Thoracic Paravertebral Block in Patients Undergoing Thoracoscopic Surgery: A Prospective, Randomized, and Double-blinded Study. Clin J Pain. 2022 Jun 1;38(6):410-417. doi: 10.1097/AJP.0000000000001037.

    PMID: 35442613BACKGROUND
  • Chen L, Wu Y, Cai Y, Ye Y, Li L, Xia Y, Papadimos TJ, Xu X, Wang Q. Comparison of programmed intermittent bolus infusion and continuous infusion for postoperative patient-controlled analgesia with thoracic paravertebral block catheter: a randomized, double-blind, controlled trial. Reg Anesth Pain Med. 2019 Feb;44(2):240-245. doi: 10.1136/rapm-2018-000031. Epub 2019 Jan 5.

    PMID: 30700619BACKGROUND
  • Law WZW, Sara RA, Cameron AJD, Lightfoot NJ. Local anaesthetic delivery regimens for peripheral nerve catheters: a systematic review and network meta-analysis. Anaesthesia. 2020 Mar;75(3):395-405. doi: 10.1111/anae.14864. Epub 2019 Oct 14.

    PMID: 31612480BACKGROUND
  • Jagannathan R, Niesen AD, D'Souza RS, Johnson RL. Intermittent bolus versus continuous infusion techniques for local anesthetic delivery in peripheral and truncal nerve analgesia: the current state of evidence. Reg Anesth Pain Med. 2019 Apr;44(4):447-451. doi: 10.1136/rapm-2018-100082. Epub 2019 Feb 3.

    PMID: 30914472BACKGROUND
  • Duan L, Zhang L, Shi CG, Huang LG, Ao H, Wang ZP, Deng Y, Sun ML. Comparison of continuous pericapsular nerve group (PENG) block versus continuous fascia iliaca compartment block on pain management and quadriceps muscle strength after total hip arthroplasty: a prospective, randomized controlled study. BMC Anesthesiol. 2023 Jul 11;23(1):233. doi: 10.1186/s12871-023-02190-1.

    PMID: 37434138BACKGROUND
  • Senthil KS, Kumar P, Ramakrishnan L. Comparison of Pericapsular Nerve Group Block versus Fascia Iliaca Compartment Block as Postoperative Pain Management in Hip Fracture Surgeries. Anesth Essays Res. 2021 Oct-Dec;15(4):352-356. doi: 10.4103/aer.aer_119_21. Epub 2022 Mar 1.

    PMID: 35422548BACKGROUND
  • 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
  • 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
  • Butcher NJ, Monsour A, Mew EJ, Chan AW, Moher D, Mayo-Wilson E, Terwee CB, Chee-A-Tow A, Baba A, Gavin F, Grimshaw JM, Kelly LE, Saeed L, Thabane L, Askie L, Smith M, Farid-Kapadia M, Williamson PR, Szatmari P, Tugwell P, Golub RM, Monga S, Vohra S, Marlin S, Ungar WJ, Offringa M. Guidelines for Reporting Outcomes in Trial Protocols: The SPIRIT-Outcomes 2022 Extension. JAMA. 2022 Dec 20;328(23):2345-2356. doi: 10.1001/jama.2022.21243.

    PMID: 36512367BACKGROUND

MeSH Terms

Conditions

Hip FracturesAgnosia

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Benjamin P Atterton, MBChB FRCA

    Cork University Hospital & University College Cork

    STUDY DIRECTOR

Central Study Contacts

Brian D O'Donnell, MBBChBAO MSc FCARCSI MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Anaesthesiologist

Study Record Dates

First Submitted

June 22, 2025

First Posted

July 1, 2025

Study Start

March 28, 2024

Primary Completion

January 7, 2026

Study Completion

January 7, 2026

Last Updated

July 1, 2025

Record last verified: 2025-06

Locations