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

Primary Purpose

Anesthesia, Conduction

Status
Not yet recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Ropivacaine + saline solution
Saline solution + Ropivacaine
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia, Conduction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Odilon Behrens

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Suprainguinal Fascia Iliaca Block Group

PENG Block + Lateral Femoral Cutaneous Nerve Block Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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).
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).

Secondary Outcome Measures

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)..
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.
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.
Total intravenous morphine dose in milligram over 24 hours
To quantify the total rescue morphine dose (or morphine equivalent) in mg over 24h.
Time of the first morphine order in minutes
To record the time of the first morphine order in minutes after the spinal anesthesia
Incidence of opioid side effects
To record the incidence of opioid side effects - nausea/vomiting, pruritus, urinary retention and respiratory depression
Incidence of blockades complications
To record the incidence of blockades complications - vascular puncture, hematoma, local anesthetic toxicity and nerve injury.
Incidence of delirium
To evaluate altered cognition and conclude as positive or negative.

Full Information

First Posted
February 8, 2023
Last Updated
February 27, 2023
Sponsor
Federal University of Minas Gerais
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1. Study Identification

Unique Protocol Identification Number
NCT05749367
Brief Title
Lateral Cutaneous Nerve and PENG Blocks Versus Suprainguinal Fascia Iliaca Block in Post-op Analgesia of Hip Fractures
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 6, 2023 (Anticipated)
Primary Completion Date
October 10, 2023 (Anticipated)
Study Completion Date
October 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Conduction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, controlled, randomized and double blind
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Suprainguinal Fascia Iliaca Block Group
Arm Type
Active Comparator
Arm Description
Patients will undergo SIFIB with ropivacaine and PENG plus LFCNB with saline solution.
Arm Title
PENG Block + Lateral Femoral Cutaneous Nerve Block Group
Arm Type
Experimental
Arm Description
Patients will undergo SIFIB with saline solution and PENG plus LFCNB ropivacaine.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine + saline solution
Other Intervention Name(s)
Naropin + saline solution
Intervention Description
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
Intervention Name(s)
Saline solution + Ropivacaine
Other Intervention Name(s)
Saline solution + Naropin
Intervention Description
SIFIB with 30 ml of saline solution and PENG Block plus LFCNB with 20 ml and 10 ml of 0,5% ropivacaine, respectively.
Primary Outcome Measure Information:
Title
Dynamic Post-op Hip Pain
Description
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).
Time Frame
6 hours after spinal anesthesia.
Title
Dynamic Post-op Hip Pain
Description
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).
Time Frame
12 hours after spinal anesthesia
Title
Dynamic Post-op Hip Pain
Description
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).
Time Frame
24 hours after spinal anesthesia
Secondary Outcome Measure Information:
Title
Post-op Hip Pain at Rest
Description
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)..
Time Frame
6 hours, 12 hours and 24 hours after spinal anesthesia.
Title
Quadriceps muscle strength measured by dynamometry in newton (N).
Description
To test the quadriceps muscle strength by dynamometry (Med Force hand-held push dynamometer, tHHD, MED.DOR Ltd., Governador Valadares, Brazil) in newton.
Time Frame
6 hours, 12 hours and 24 hours after spinal anesthesia.
Title
Quadriceps muscle strength index
Description
To calculate quadriceps muscle strength index by the ratio between the strengths (collected by dynamometry) of the non-operated and operated lower limbs.
Time Frame
6 hours, 12 hours and 24 hours after spinal anesthesia.
Title
Total intravenous morphine dose in milligram over 24 hours
Description
To quantify the total rescue morphine dose (or morphine equivalent) in mg over 24h.
Time Frame
24 hours
Title
Time of the first morphine order in minutes
Description
To record the time of the first morphine order in minutes after the spinal anesthesia
Time Frame
24 hours
Title
Incidence of opioid side effects
Description
To record the incidence of opioid side effects - nausea/vomiting, pruritus, urinary retention and respiratory depression
Time Frame
24 hours
Title
Incidence of blockades complications
Description
To record the incidence of blockades complications - vascular puncture, hematoma, local anesthetic toxicity and nerve injury.
Time Frame
24 hours
Title
Incidence of delirium
Description
To evaluate altered cognition and conclude as positive or negative.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leonardo SG Oliveira, MD
Phone
55 31988870672
Email
saraivaleo@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Renato S Gomez, Ph.D
Phone
55 31988619475
Email
renatogomez2000@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonardo SG Oliveira, MD
Organizational Affiliation
Hospital Municipal Odilon Behrens - Belo Horizonte/Brazil and Universidade Federal de Minas Gerais
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Odilon Behrens
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
31.110-430
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonardo SG Oliveira, MD
Phone
55 31988870672
Email
saraivaleo@gmail.com
First Name & Middle Initial & Last Name & Degree
Renata A Chaves, MD
Phone
55 31992772423
Email
re_chaves@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30063657
Citation
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.
Results Reference
background
PubMed Identifier
33238043
Citation
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.
Results Reference
background
PubMed Identifier
30092937
Citation
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.
Results Reference
background
PubMed Identifier
30798268
Citation
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.
Results Reference
background
PubMed Identifier
28059869
Citation
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.
Results Reference
background
PubMed Identifier
33109730
Citation
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.
Results Reference
background
PubMed Identifier
34290085
Citation
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.
Results Reference
background
PubMed Identifier
33637625
Citation
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.
Results Reference
background
PubMed Identifier
35054353
Citation
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.
Results Reference
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Lateral Cutaneous Nerve and PENG Blocks Versus Suprainguinal Fascia Iliaca Block in Post-op Analgesia of Hip Fractures

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