PENG vs Femoral Block for Hip Fracture Analgesia

Официальное название

PENG vs Femoral Block for Hip Fracture, A Pragmatic Cluster-Randomized Study

Обзор

This study aims to compare the Pericapsular Nerve Group (PENG) block with femoral block for hip fracture pain. Participants presenting to the hospital with a diagnosis of hip fracture and consenting to analgesic block will receive either a PENG or femoral block. The choice of block will be dictated by a randomized monthly schedule, and all participants presenting during each four-week period will receive the designated block. A sub-group analysis will be performed to determine any difference in efficacy in participants with intracapsular versus extracapsular fractures.

Подробное описание

Each year, 250,000 adults in the US and 1.6 million worldwide suffer hip fractures. Peripheral nerve blocks, including femoral blocks, administered soon after admission to patients presenting with hip fractures have been shown to produce clinically and statistically significant reductions in pain scores, opioid consumption, the incidence of confusional state, and the time to mobilization.

Historically, lower extremity blocks for hip fracture pain have targeted the femoral nerve. The PENG block is a relatively novel ultrasound guided block that was first described in 2018 as an alternative to the more traditional femoral block for regional hip analgesia in hip fracture patients. The PENG block targets articular branches of the obturator nerve and accessory obturator nerve, as well as branches of the femoral nerve, the combination of which richly innervate the anterior hip capsule. In a case series of 5 patients presenting to the Emergency Department with hip fracture pain, the PENG block was demonstrated to be an effective nerve block for hip analgesia by reducing the numerical rating scale pain scores by 7 points on a 10 point scale. A larger study compared the PENG block to placebo, also in hip fracture patients presenting to the Emergency Department, and demonstrated a significant decrease of 3 in the dynamic NRS pain score at 1 and 3 hours post-block. A Cochrane review in 2017 demonstrated femoral blocks to have a 3.4 point reduction in pain scores compared to placebo. No study to date has compared the PENG block to the femoral block for acute hip fracture pain.

This study aims to compare the PENG block with femoral block for acute hip fracture pain in patients upon presentation who have not undergone surgical repair. Patients presenting to the hospital with a diagnosis of hip fracture and consenting to analgesic block will receive either a PENG or femoral block. The choice of block will be dictated by a randomized monthly schedule, and all patients presenting during each four-week period will receive the designated block. The primary outcome will be the change in NRS pain score from pre-block to one-hour post-block. Secondary outcomes will include NRS pain scores and opioid consumption for 24 hours post-block. A sub-group analysis will be performed to determine any difference in efficacy in patients with intracapsular versus extracapsular fractures.

This will be a pragmatic study with a multiple crossover cluster-controlled design. In this type of trial an intervention is implemented for all patients for a limited period of time and then substituted with the alternate intervention for a comparable amount of time. The order of intervention will be randomized. The repetition of the study periods, especially if conducted over a period of a year of more, has the effect of reducing time-dependent confounding from background improvements in healthcare and regression to the mean. The Hawthorne effect will be limited in this particular case because both of the interventions are already routinely and interchangeably used in our current practice for hip fracture analgesia. Research consent is usually waived in this type of trial design because the treatment received by subjects is identical to standard care and the exposure within a subject population is based only on time period rather than patient characteristics or consent.

As per current standard of care, all hip fracture patients admitted Monday - Friday, 7AM - 5PM, will be offered an analgesic lower extremity peripheral nerve block. Each month of the study will be randomized to either PENG or femoral block. All patients who consent to a block during each month will receive the designated block.

Data will be collected from the electronic medical record (EMR).

Вмешательства

• Процедура PENG Block Administration
  Policy for the PENG block administration: 30 mL of Bupivacaine 0.25% 1:200,000 epinephrine Dexamethasone 4 mg% While these drugs are administered to participants, the intervention under evaluation is the PENG Block anesthesia technique.
• Процедура Femoral Block Administration
  Policy for the Femoral block administration: 30 mL of Bupivacaine 0.25% 1:200,000 epinephrine Dexamethasone 4 mg While these drugs are administered to participants, the intervention under evaluation is the Femoral Block anesthesia technique.
• Препарат Bupivacaine , epinephrine Dexamethasone
  30 mL of Bupivacaine 0.25% 1:200,000 epinephrine Dexamethasone 4 mg%

Первичные конечные точки

• Mean Change in Numerical Rating Scale (NRS) Pain Score One Hour Post Block for all Subjects [Срок оценки: Baseline, 1-hour post block]
• Mean Change in Numerical Rating Scale (NRS) Pain Score One-Hour Post Block in Intracapsular Hip Fractures [Срок оценки: Baseline, 1-hour post block]
• Mean Change in Numerical Rating Scale (NRS) Pain Score One-Hour Post Block in Extracapsular Hip Fractures [Срок оценки: Baseline, 1-hour post block]

Вторичные конечные точки (6)

• Mean NRS Pain Scores up to 24 Hours Post-block for all Subjects [Срок оценки: 0-24 hours post block]
• Mean NRS Pain Scores up to 24 Hours Post-block in Intracapsular Hip Fractures [Срок оценки: 0-24 hours post block]
• Mean NRS Pain Scores up to 24 Hours Post-block in Extracapsular Hip Fractures [Срок оценки: 0-24 hours post block]
• Number of Oral Morphine Equivalents Administered for all Subjects [Срок оценки: 0-24 hours post block]
• Number of Oral Morphine Equivalents Administered in Intracapsular Hip Fractures [Срок оценки: 0-24 hours post block]
• Number of Oral Morphine Equivalents Administered in Extracapsular Hip Fractures [Срок оценки: 0-24 hours post block]

Критерии участия

Критерии включения

• Male or female ≥ 18 years of age.
• ASA Classification 1-4
• Documentation of a hip fracture diagnosis along with radiologic read indicating fracture location
• Written, informed consent for analgesic peripheral block placement

Критерии исключения

• Altered mental status to the extent that it limits ability to report pain score
• Patient or health care proxy refusal of analgesic nerve block
• Allergy to study medications or contraindication to peripheral nerve block
• Peri-prosthetic fracture
• Any additional fractures in a patient with a unilateral hip fracture

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Weill Cornell Medicine — Manhattan

Публикации

• Neuman MD, Feng R, Carson JL, Gaskins LJ, Dillane D, Sessler DI, Sieber F, Magaziner J, Marcantonio ER, Mehta S, Menio D, Ayad S, Stone T, Papp S, Schwenk ES, Elkassabany N, Marshall M, Jaffe JD, Luke C, Sharma B, Azim S, Hymes RA, Chin KJ, Sheppard R, Perlman B, Sappenfield J, Hauck E, Hoeft MA, Giska M, Ranganath Y, Tedore T, Choi S, Li J, Kwofie MK, Nader A, Sanders RD, Allen BFS, Vlassakov K, PMID 34623788
• Riddell M, Ospina M, Holroyd-Leduc JM. Use of Femoral Nerve Blocks to Manage Hip Fracture Pain among Older Adults in the Emergency Department: A Systematic Review. CJEM. 2016 Jul;18(4):245-52. doi: 10.1017/cem.2015.94. Epub 2015 Sep 10. PMID 26354332
• Ritcey B, Pageau P, Woo MY, Perry JJ. Regional Nerve Blocks For Hip and Femoral Neck Fractures in the Emergency Department: A Systematic Review. CJEM. 2016 Jan;18(1):37-47. doi: 10.1017/cem.2015.75. Epub 2015 Sep 2. PMID 26330019
• Scurrah A, Shiner CT, Stevens JA, Faux SG. Regional nerve blockade for early analgesic management of elderly patients with hip fracture - a narrative review. Anaesthesia. 2018 Jun;73(6):769-783. doi: 10.1111/anae.14178. Epub 2017 Dec 26. PMID 29278266
• Giron-Arango L, Peng P. Pericapsular nerve group (PENG) block: what have we learned in the last 5 years? Reg Anesth Pain Med. 2025 May 6;50(5):402-409. doi: 10.1136/rapm-2024-105427. PMID 38724271
• Guay J, Parker MJ, Griffiths R, Kopp S. Peripheral nerve blocks for hip fractures. Cochrane Database Syst Rev. 2017 May 11;5(5):CD001159. doi: 10.1002/14651858.CD001159.pub2. PMID 28494088
• Griffiths R, Babu S, Dixon P, Freeman N, Hurford D, Kelleher E, Moppett I, Ray D, Sahota O, Shields M, White S. Guideline for the management of hip fractures 2020: Guideline by the Association of Anaesthetists. Anaesthesia. 2021 Feb;76(2):225-237. doi: 10.1111/anae.15291. Epub 2020 Dec 2. PMID 33289066
• White SM, Altermatt F, Barry J, Ben-David B, Coburn M, Coluzzi F, Degoli M, Dillane D, Foss NB, Gelmanas A, Griffiths R, Karpetas G, Kim JH, Kluger M, Lau PW, Matot I, McBrien M, McManus S, Montoya-Pelaez LF, Moppett IK, Parker M, Porrill O, Sanders RD, Shelton C, Sieber F, Trikha A, Xuebing X. International Fragility Fracture Network Delphi consensus statement on the principles of anaesthesia for PMID 29508382

Идентификаторы

NCT: NCT07073209 · 24-07027709

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗