Lateral Cutaneous Nerve and PENG Blocks Versus Suprainguinal Fascia Iliaca Block in Post-op Analgesia of Hip Fractures

Lateral Femoral Cutaneous Nerve and Pericapsular Nerve Group (PENG) Blocks Versus Suprainguinal Fascia Iliaca Block in Postoperative Analgesia of Hip Fractures: a Prospective, Controlled, Randomized and Double Blind Study

Postoperative pain in hip fractures is challenging and requires adequate management. Peripheral nerve blocks are already known as superior than systemic analgesia in this scenario, but the best analgesic regional technique is still unknown. The investigators propose a study to compare the postoperative analgesia of hip fractures between pericapsular nerve group block plus lateral femoral cutaneous nerve block and suprainguinal fascia iliaca block

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthesia, Conduction
• Intervention / Treatment: Drug: Ropivacaine + saline solution; Drug: Saline solution + Ropivacaine

Detailed Description

Postoperative pain in hip fractures is challenging and requires adequate management. In this scenario, peripheral nerve blocks present superior results to systemic analgesia, minimizing the use of opioids and their adverse effects. The lumbar plexus is responsible for the nociception of the hip joint through the femoral, obturator, and accessory obturator nerves, besides being responsible for the sensory innervation of the lateral aspect of the thigh through the lateral femoral cutaneous nerve. Due to this intricate network, several regional techniques have already been proposed. However, the best analgesic approach is still unknown. Ultrasound-guided suprainguinal fascia iliaca block (SIFIB), which addresses the femoral and lateral femoral cutaneous nerves, and ultrasound-guided pericapsular nerve group block (PENG), which addresses terminal branches of the femoral and accessory obturator nerves, are techniques currently used successfully in the context of analgesia for hip surgery. PENG block generates less motor impairment of the quadriceps, which can be significant in terms of mobility and rehabilitation. Both techniques show similar analgesic results in the still scarce literature, but SIFIB has shown slight advantage in some scenarios. However, the PENG block does not reach the lateral cutaneous nerve, which may lead to greater postoperative pain perception. In an attempt to fill this knowledge gap, the investigators propose a study to analyze whether the association between PENG block and lateral femoral cutaneous nerve block (LFCNB) promotes postoperative analgesia equal to SIFIB in a population of adults with hip fractures. This will be a prospective, controlled, randomized, double blind study. Patients with hip fractures (femoral neck, transtrochanteric and subtrochanteric) who will undergo surgical treatment (hip arthroplasty and osteosynthesis with intramedullary nails or screws) will be recruited and randomly allocated into two groups: control (C) and experimental (E). In group C, patients will undergo SIFIB with 30 ml of 0.5% ropivacaine, and to maintain blinding they will also undergo PENG and LFCNB with 20 ml and 10 ml of saline, respectively. In group E, patients will receive the PENG block associated with LFCNB, with 20ml + 10ml of 0.5% ropivacaine, respectively, and 30 ml of saline solution in the SIFIB. After performing the blocks, all patients will undergo spinal anesthesia, with intrathecal injection of 10mg of 0.5% isobaric bupivacaine. As a primary objective, the investigators will evaluate dynamic pain (passive elevation of the leg at 15°) using the Numeric Rating Scale (0-10), 6 hours, 12 hours and 24 hours after spinal anesthesia.

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leonardo SG Oliveira, MD; Phone Number: 55 31988870672; Email: saraivaleo@gmail.com
• Study Contact Backup: Name: Renato S Gomez, Ph.D; Phone Number: 55 31988619475; Email: renatogomez2000@yahoo.com.br

Study Locations

• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 31.110-430
      • Hospital Odilon Behrens
      • Contact: Leonardo SG Oliveira, MD; Phone Number: 55 31988870672; Email: saraivaleo@gmail.com
      • Contact: Renata A Chaves, MD; Phone Number: 55 31992772423; Email: re_chaves@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with hip fractures who will undergo surgical treatment.
• Adults over 18 years.
• American Society of Anesthesiology physical status 1 to 3.
• Body mass index (BMI) < 35 Kg/m2.

Exclusion Criteria:

• Local anesthetic allergy
• Coagulopathy
• American Society of Anesthesiology physical status ≥ 4,
• Dementia
• Peripheral polyneuropathy
• Pregnancy
• Chronic opioid use (> 3 months)
• BMI >35 Kg/m2
• Stroke with lower limb motor sequelae
• Patient refusal/withdrawal
• Those whose spinal anesthesia has been changed to general anesthesia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Suprainguinal Fascia Iliaca Block Group; Patients will undergo SIFIB with ropivacaine and PENG plus LFCNB with saline solution.	Drug: Ropivacaine + saline solution; SIFIB with 30 ml of 0.5% ropivacaine and PENG Block plus LFCNB with 20 ml and 10 ml of saline solution, respectively.; Other Names: Naropin + saline solution
Experimental: PENG Block + Lateral Femoral Cutaneous Nerve Block Group; Patients will undergo SIFIB with saline solution and PENG plus LFCNB ropivacaine.	Drug: Saline solution + Ropivacaine; SIFIB with 30 ml of saline solution and PENG Block plus LFCNB with 20 ml and 10 ml of 0,5% ropivacaine, respectively.; Other Names: Saline solution + Naropin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamic Post-op Hip Pain	To assess dynamic hip pain (passive leg elevation at 15°) in postoperative period using the Numeric Rating Scale (0-10), on which patients rate their current pain intensity from (no pain) to 10 (worst possible pain).	6 hours after spinal anesthesia.
Dynamic Post-op Hip Pain	To assess dynamic hip pain (passive leg elevation at 15°) in postoperative period using the Numeric Rating Scale (0-10), on which patients rate their current pain intensity from (no pain) to 10 (worst possible pain).	12 hours after spinal anesthesia
Dynamic Post-op Hip Pain	To assess dynamic hip pain (passive leg elevation at 15°) in postoperative period using the Numeric Rating Scale (0-10), on which patients rate their current pain intensity from (no pain) to 10 (worst possible pain).	24 hours after spinal anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-op Hip Pain at Rest	To evaluate hip pain at rest in postoperative period using the Numeric Rating Scale (0-10), on which patients rate their current pain intensity from ) (no pain) to 10 (worst possible pain)..	6 hours, 12 hours and 24 hours after spinal anesthesia.
Quadriceps muscle strength measured by dynamometry in newton (N).	To test the quadriceps muscle strength by dynamometry (Med Force hand-held push dynamometer, tHHD, MED.DOR Ltd., Governador Valadares, Brazil) in newton.	6 hours, 12 hours and 24 hours after spinal anesthesia.
Quadriceps muscle strength index	To calculate quadriceps muscle strength index by the ratio between the strengths (collected by dynamometry) of the non-operated and operated lower limbs.	6 hours, 12 hours and 24 hours after spinal anesthesia.
Total intravenous morphine dose in milligram over 24 hours	To quantify the total rescue morphine dose (or morphine equivalent) in mg over 24h.	24 hours
Time of the first morphine order in minutes	To record the time of the first morphine order in minutes after the spinal anesthesia	24 hours
Incidence of opioid side effects	To record the incidence of opioid side effects - nausea/vomiting, pruritus, urinary retention and respiratory depression	24 hours
Incidence of blockades complications	To record the incidence of blockades complications - vascular puncture, hematoma, local anesthetic toxicity and nerve injury.	24 hours
Incidence of delirium	To evaluate altered cognition and conclude as positive or negative.	24 hours

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais
• Investigators: Principal Investigator: Leonardo SG Oliveira, MD, Hospital Municipal Odilon Behrens - Belo Horizonte/Brazil and Universidade Federal de Minas Gerais

Publications and helpful links

General Publications

• Vermeylen K, Desmet M, Leunen I, Soetens F, Neyrinck A, Carens D, Caerts B, Seynaeve P, Hadzic A, Van de Velde M. Supra-inguinal injection for fascia iliaca compartment block results in more consistent spread towards the lumbar plexus than an infra-inguinal injection: a volunteer study. Reg Anesth Pain Med. 2019 Feb 22:rapm-2018-100092. doi: 10.1136/rapm-2018-100092. Online ahead of print.
• Bugada D, Bellini V, Lorini LF, Mariano ER. Update on Selective Regional Analgesia for Hip Surgery Patients. Anesthesiol Clin. 2018 Sep;36(3):403-415. doi: 10.1016/j.anclin.2018.04.001. Epub 2018 Jul 11.
• Desmet M, Vermeylen K, Van Herreweghe I, Carlier L, Soetens F, Lambrecht S, Croes K, Pottel H, Van de Velde M. A Longitudinal Supra-Inguinal Fascia Iliaca Compartment Block Reduces Morphine Consumption After Total Hip Arthroplasty. Reg Anesth Pain Med. 2017 May/Jun;42(3):327-333. doi: 10.1097/AAP.0000000000000543.
• 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.
• Aliste J, Layera S, Bravo D, Jara A, Munoz G, Barrientos C, Wulf R, Branez J, Finlayson RJ, Tran Q. Randomized comparison between pericapsular nerve group (PENG) block and suprainguinal fascia iliaca block for total hip arthroplasty. Reg Anesth Pain Med. 2021 Oct;46(10):874-878. doi: 10.1136/rapm-2021-102997. Epub 2021 Jul 20.
• Lin DY, Morrison C, Brown B, Saies AA, Pawar R, Vermeulen M, Anderson SR, Lee TS, Doornberg J, Kroon HM, Jaarsma RL. Pericapsular nerve group (PENG) block provides improved short-term analgesia compared with the femoral nerve block in hip fracture surgery: a single-center double-blinded randomized comparative trial. Reg Anesth Pain Med. 2021 May;46(5):398-403. doi: 10.1136/rapm-2020-102315. Epub 2021 Feb 26.
• 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. Erratum In: Reg Anesth Pain Med. 2022 May;47(5):e1.
• Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.
• Macedo MC, Souza MA, Ferreira KR, Campos LO, Souza ISO, Barbosa MA, Brito CJ, Intelangelo L, Barbosa AC. Validity and Test-Retest Reliability of a Novel Push Low-Cost Hand-Held Dynamometer for Knee Strength Assessment during Different Force Ranges. Diagnostics (Basel). 2022 Jan 13;12(1):186. doi: 10.3390/diagnostics12010186.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 6, 2023
• Primary Completion (Anticipated): October 10, 2023
• Study Completion (Anticipated): October 10, 2023

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): March 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Pharmaceutical Solutions; Ropivacaine
• Other Study ID Numbers: CAAE:42438721.1.0000.5129

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No