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

Sponsor
Federal University of Minas Gerais (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05749367
Collaborator
(none)
66
1
2
7.2
9.2

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Ropivacaine + saline solution
  • Drug: Saline solution + Ropivacaine
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective, controlled, randomized and double blindProspective, controlled, randomized and double blind
Masking:
Quadruple (Participant, Care Provider, 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.
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Mar 6, 2023
Anticipated Primary Completion Date :
Oct 10, 2023
Anticipated Study Completion Date :
Oct 10, 2023

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Dynamic Post-op Hip Pain [6 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).

    2. Dynamic Post-op Hip Pain [12 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).

    3. Dynamic Post-op Hip Pain [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 Outcome Measures

    1. Post-op Hip Pain at Rest [6 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)..

    2. 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.

    3. Quadriceps muscle strength index [6 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.

    4. Total intravenous morphine dose in milligram over 24 hours [24 hours]

      To quantify the total rescue morphine dose (or morphine equivalent) in mg over 24h.

    5. Time of the first morphine order in minutes [24 hours]

      To record the time of the first morphine order in minutes after the spinal anesthesia

    6. Incidence of opioid side effects [24 hours]

      To record the incidence of opioid side effects - nausea/vomiting, pruritus, urinary retention and respiratory depression

    7. Incidence of blockades complications [24 hours]

      To record the incidence of blockades complications - vascular puncture, hematoma, local anesthetic toxicity and nerve injury.

    8. Incidence of delirium [24 hours]

      To evaluate altered cognition and conclude as positive or negative.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Odilon Behrens Belo Horizonte Minas Gerais Brazil 31.110-430

    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Renato Santiago Gomez, Professor of Surgery Department at Medical School of Universidade Federal de Minas Gerais. Ph.D, Federal University of Minas Gerais
    ClinicalTrials.gov Identifier:
    NCT05749367
    Other Study ID Numbers:
    • CAAE:42438721.1.0000.5129
    First Posted:
    Mar 1, 2023
    Last Update Posted:
    Mar 1, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 1, 2023