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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05749367
Enrollment
66
Registered
2023-03-01
Start date
2023-03-06
Completion date
2023-10-10
Last updated
2023-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Conduction

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.

Interventions

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

DRUGSaline 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.

Sponsors

Federal University of Minas Gerais
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

In the control group, patients will undergo SIFIB with ropivacaine and to maintain the masking they will also undergo PENG and LFCNB with saline solution (sham block). In the experimental group, patients will receive ropivacaine in the PENG block associated with LFCNB and saline solution in the SIFIB. All the work of randomization, editing of the spreadsheet, manipulation of the envelopes, as well as the confidential tabulation of the data during collection will be done by an assistant who will not participate in the anesthesia or data collection. The opening of the envelopes and the preparation of the material for anesthesia will also be done by an assistant who will not participate in the evaluation of the outcomes. The researcher will perform all the procedures and data collection and will not know which group the participant belongs to. The patient will also not know in which group he or she is allocated.

Intervention model description

Prospective, controlled, randomized and double blind

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Dynamic Post-op Hip Pain6 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

MeasureTime frameDescription
Quadriceps muscle strength measured by dynamometry in newton (N).6 hours, 12 hours and 24 hours after spinal anesthesia.To test the quadriceps muscle strength by dynamometry (Med Force hand-held push dynamometer, tHHD, MED.DOR Ltd., Governador Valadares, Brazil) in newton.
Quadriceps muscle strength index6 hours, 12 hours and 24 hours after spinal anesthesia.To calculate quadriceps muscle strength index by the ratio between the strengths (collected by dynamometry) of the non-operated and operated lower limbs.
Total intravenous morphine dose in milligram over 24 hours24 hoursTo quantify the total rescue morphine dose (or morphine equivalent) in mg over 24h.
Post-op Hip Pain at Rest6 hours, 12 hours and 24 hours after spinal anesthesia.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)..
Incidence of opioid side effects24 hoursTo record the incidence of opioid side effects - nausea/vomiting, pruritus, urinary retention and respiratory depression
Incidence of blockades complications24 hoursTo record the incidence of blockades complications - vascular puncture, hematoma, local anesthetic toxicity and nerve injury.
Incidence of delirium24 hoursTo evaluate altered cognition and conclude as positive or negative.
Time of the first morphine order in minutes24 hoursTo record the time of the first morphine order in minutes after the spinal anesthesia

Countries

Brazil

Contacts

Primary ContactLeonardo SG Oliveira, MD
saraivaleo@gmail.com55 31988870672
Backup ContactRenato S Gomez, Ph.D
renatogomez2000@yahoo.com.br55 31988619475

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026