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

NCT ID: NCT05749367

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-06
• Study Completion Date: 2023-10-10

Brief Summary

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

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.

Conditions

Anesthesia, Conduction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Suprainguinal Fascia Iliaca Block Group

Patients will undergo SIFIB with ropivacaine and PENG plus LFCNB with saline solution.

Group Type: ACTIVE_COMPARATOR

Ropivacaine + saline solution

Intervention Type: DRUG

SIFIB with 30 ml of 0.5% ropivacaine and PENG Block plus LFCNB with 20 ml and 10 ml of saline solution, respectively.

PENG Block + Lateral Femoral Cutaneous Nerve Block Group

Patients will undergo SIFIB with saline solution and PENG plus LFCNB ropivacaine.

Group Type: EXPERIMENTAL

Saline solution + Ropivacaine

Intervention Type: DRUG

SIFIB with 30 ml of saline solution and PENG Block plus LFCNB with 20 ml and 10 ml of 0,5% ropivacaine, respectively.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Naropin + saline solution; Saline solution + Naropin

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Minas Gerais

OTHER

Sponsor Role: lead

Responsible Party

Renato Santiago Gomez

Professor of Surgery Department at Medical School of Universidade Federal de Minas Gerais. Ph.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leonardo SG Oliveira, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Municipal Odilon Behrens - Belo Horizonte/Brazil and Universidade Federal de Minas Gerais

Locations

Hospital Odilon Behrens

Belo Horizonte, Minas Gerais, Brazil

Countries

Brazil

Central Contacts

Leonardo SG Oliveira, MD

Role: CONTACT

saraivaleo@gmail.com

55 31988870672

Renato S Gomez, Ph.D

Role: CONTACT

renatogomez2000@yahoo.com.br

55 31988619475

Facility Contacts

Leonardo SG Oliveira, MD

Role: primary

saraivaleo@gmail.com

55 31988870672

Renata A Chaves, MD

Role: backup

re_chaves@hotmail.com

55 31992772423

References

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.

Reference Type: BACKGROUND

PMID: 30063657 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33238043 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30092937 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 30798268 (View on PubMed)

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Reference Type: BACKGROUND

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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.

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Reference Type: BACKGROUND

PMID: 34290085 (View on PubMed)

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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

CAAE:42438721.1.0000.5129

Identifier Type: -

Identifier Source: org_study_id