Anesthesia, ConductionNCT05749367
Lateral Cutaneous Nerve and PENG Blocks Versus Suprainguinal Fascia Iliaca Block in Post-op Analgesia of Hip Fractures
A study testing Ropivacaine + saline solution and Saline solution + Ropivacaine in people with Anesthesia, Conduction, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Conduction
- What is being tested?
- Ropivacaine + saline solution and Saline solution + Ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Mar 2023to 10 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Local anesthetic allergy
- Coagulopathy
- American Society of Anesthesiology physical status ≥ 4,
- Dementia
- Peripheral polyneuropathy
- Pregnancy
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Odilon Behrens
Belo Horizonte, Minas Gerais, 31.110-430
Leonardo SG Oliveira, MD, 55 31988870672, saraivaleo@gmail.com
Renata A Chaves, MD, 55 31992772423, re_chaves@hotmail.com
About this study
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
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
Read the 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
- Being tested
- Ropivacaine + saline solution, Saline solution + Ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine + saline solutionDrug
Also called Naropin + 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.
Saline solution + RopivacaineDrug
Also called Saline solution + Naropin
SIFIB with 30 ml of saline solution and PENG Block plus LFCNB with 20 ml and 10 ml of 0,5% ropivacaine, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Suprainguinal Fascia Iliaca Block Group | Active comparator | Patients will undergo SIFIB with ropivacaine and PENG plus LFCNB with saline solution. Receives: Drug: Ropivacaine + saline solution |
| PENG Block + Lateral Femoral Cutaneous Nerve Block Group | Experimental | Patients will undergo SIFIB with saline solution and PENG plus LFCNB ropivacaine. Receives: Drug: Saline solution + Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 hours after spinal anesthesia.
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).
Measured: 12 hours after spinal anesthesia
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).
Measured: 24 hours after spinal anesthesia
Secondary outcomes (8)
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)..
Measured: 6 hours, 12 hours and 24 hours after spinal anesthesia.
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.
Measured: 6 hours, 12 hours and 24 hours after spinal anesthesia.
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.
Measured: 6 hours, 12 hours and 24 hours after spinal anesthesia.
Total intravenous morphine dose in milligram over 24 hours
To quantify the total rescue morphine dose (or morphine equivalent) in mg over 24h.
Measured: 24 hours
Time of the first morphine order in minutes
To record the time of the first morphine order in minutes after the spinal anesthesia
Measured: 24 hours
Incidence of opioid side effects
To record the incidence of opioid side effects - nausea/vomiting, pruritus, urinary retention and respiratory depression
Measured: 24 hours
Incidence of blockades complications
To record the incidence of blockades complications - vascular puncture, hematoma, local anesthetic toxicity and nerve injury.
Measured: 24 hours
Incidence of delirium
To evaluate altered cognition and conclude as positive or negative.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start6 Mar 2023 (estimated)
- Primary completion10 Oct 2023 (estimated)
- Study completion10 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, ConductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, controlled, randomized and double blind
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renato Santiago Gomez, Federal University of Minas Gerais
- Investigators
- Leonardo SG Oliveira, MD, Principal investigator, Hospital Municipal Odilon Behrens - Belo Horizonte/Brazil and Universidade Federal de Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749367
- Sponsor's protocol ID
- CAAE:42438721.1.0000.5129
- Status last verified
- Feb 2023
- First submitted
- 8 Feb 2023
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30063657Guay 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.
PubMed 33238043Bugada 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.
PubMed 30092937Vermeylen 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.
PubMed 30798268Desmet 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.
PubMed 28059869Morrison 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.
PubMed 33109730Aliste 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.
PubMed 34290085Lin 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.
PubMed 33637625Macedo 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.
PubMed 35054353
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05749367
- Acronym / sponsor ID
- CAAE:42438721.1.0000.5129
- Conditions
- Anesthesia, Conduction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- 6 Mar 2023 (estimated)
- Primary completion
- 10 Oct 2023 (estimated)
- Study completion
- 10 Oct 2023 (estimated)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, controlled, randomized and double blind
| Arm | Type | Receives |
|---|---|---|
| Suprainguinal Fascia Iliaca Block Group | Active comparator | Drug: Ropivacaine + saline solutionPatients will undergo SIFIB with ropivacaine and PENG plus LFCNB with saline solution. |
| PENG Block + Lateral Femoral Cutaneous Nerve Block Group | Experimental | Drug: Saline solution + RopivacainePatients will undergo SIFIB with saline solution and PENG plus LFCNB ropivacaine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- Local anesthetic allergy
- Coagulopathy
- American Society of Anesthesiology physical status ≥ 4,
- Dementia
- Peripheral polyneuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine + saline solutionAlso: Naropin + saline solutionSIFIB with 30 ml of 0.5% ropivacaine and PENG Block plus LFCNB with 20 ml and 10 ml of saline solution, respectively. | Drug | Suprainguinal Fascia Iliaca Block Group |
| Saline solution + RopivacaineAlso: Saline solution + NaropinSIFIB with 30 ml of saline solution and PENG Block plus LFCNB with 20 ml and 10 ml of 0,5% ropivacaine, respectively. | Drug | PENG Block + Lateral Femoral Cutaneous Nerve Block Group |
Primary outcome
Dynamic Post-op Hip Pain
Time frame: 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).
Dynamic Post-op Hip Pain
Time frame: 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).
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).
8 secondary outcomes
Post-op Hip Pain at Rest
Time frame: 6 hours, 12 hours and 24 hours after spinal anesthesia.
Quadriceps muscle strength measured by dynamometry in newton (N).
Time frame: 6 hours, 12 hours and 24 hours after spinal anesthesia.
Quadriceps muscle strength index
Time frame: 6 hours, 12 hours and 24 hours after spinal anesthesia.
Total intravenous morphine dose in milligram over 24 hours
Time frame: 24 hours
Time of the first morphine order in minutes
Time frame: 24 hours
Incidence of opioid side effects
Time frame: 24 hours
Incidence of blockades complications
Time frame: 24 hours
Incidence of delirium
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Background: PubMed 30063657Giron-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.
- Background: PubMed 33238043Guay 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.
- Background: PubMed 30092937Bugada 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.
- Background: PubMed 30798268Vermeylen 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.
- Background: PubMed 28059869Desmet 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.
- Background: PubMed 33109730Morrison 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.
- Background: PubMed 34290085Aliste 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.
- Background: PubMed 33637625Lin 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.
- Background: PubMed 35054353Macedo 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.
- Individual participant dataSharing planned: No
Related trials for Anesthesia, Conduction
Not yet recruitingObservational study
Cerebral Oximetry During Awake Carotid Endarterectomy
Carotid Stenosis, Carotid Artery Diseases
Not yet recruiting
Migration Rate for Continuous Adductor Canal Block Catheters After Primary Total Knee Arthroplasty Surgery: a Comparison Between Two Insertion Techniques
Arthroplasty Replacement, Knee, Anesthesia Conduction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonardo SG Oliveira, MD principal investigator
Hospital Municipal Odilon Behrens - Belo Horizonte/Brazil and Universidade Federal de Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine + saline solution and Saline solution + Ropivacaine in people with Anesthesia, Conduction, run by Federal University of Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leonardo SG Oliveira, MD (55 31988870672, saraivaleo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic Post-op Hip Pain (time frame: 6 hours after spinal anesthesia.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05749367, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023; AzTrials last refreshed its copy on 7 Nov 2026.