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Clinical Trials/NCT05749367
NCT05749367
Not yet recruiting
Not Applicable

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

Federal University of Minas Gerais1 site in 1 country66 target enrollmentMarch 6, 2023

Overview

Phase
Not Applicable
Intervention
Ropivacaine + saline solution
Conditions
Anesthesia, Conduction
Sponsor
Federal University of Minas Gerais
Enrollment
66
Locations
1
Primary Endpoint
Dynamic Post-op Hip Pain
Status
Not yet recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 6, 2023
End Date
October 10, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Federal University of Minas Gerais
Responsible Party
Principal Investigator
Principal Investigator

Renato Santiago Gomez

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

Federal University of Minas Gerais

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
  • Body mass index (BMI) \< 35 Kg/m2.

Exclusion Criteria

  • Local anesthetic allergy
  • Coagulopathy
  • American Society of Anesthesiology physical status ≥ 4,
  • 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.

Arms & Interventions

Suprainguinal Fascia Iliaca Block Group

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

Intervention: Ropivacaine + saline solution

PENG Block + Lateral Femoral Cutaneous Nerve Block Group

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

Intervention: Saline solution + Ropivacaine

Outcomes

Primary Outcomes

Dynamic Post-op Hip Pain

Time Frame: 24 hours after spinal anesthesia

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).

Secondary Outcomes

  • Post-op Hip Pain at Rest(6 hours, 12 hours and 24 hours after spinal anesthesia.)
  • Quadriceps muscle strength measured by dynamometry in newton (N).(6 hours, 12 hours and 24 hours after spinal anesthesia.)
  • Quadriceps muscle strength index(6 hours, 12 hours and 24 hours after spinal anesthesia.)
  • Total intravenous morphine dose in milligram over 24 hours(24 hours)
  • Time of the first morphine order in minutes(24 hours)
  • Incidence of opioid side effects(24 hours)
  • Incidence of blockades complications(24 hours)
  • Incidence of delirium(24 hours)

Study Sites (1)

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