Meralgia ParestheticaPhase 3NCT02577510
Comparing Ways to Freeze the Nerve That Provides Thigh Sensation
A Phase 3 study testing Nerve Injection- Nerve Stimulator and Nerve Injection - Ultrasound in people with Meralgia Paresthetica, run by Canadian Forces Health Services Centre Ottawa.
Trial summary
Background The sensation on the outside of portion of our thighs is provided by a nerve called the lateral femoral cutaneous nerve (LFCN). The investigators can inject freezing around the nerve to reduce the feeling around the thigh (i.e. anesthesia). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Meralgia Paresthetica
- What is being tested?
- Nerve Injection- Nerve Stimulator and Nerve Injection - Ultrasound
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Jun 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- male and female between 18 and 60 years old
- American Society of Anesthesiologists classification 1-3
Who cannot join
- adults who are unable to give their own consent
- pre-existing neuropathy (assessed by history and physical examination) -
- coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
- renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
- hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
- allergy to local anesthetic agents local anesthetic
Show all 12Show fewer
- pregnancy based on patient self report of last menstrual cycle. If a patient wish/insist on participating in the study, and pregnancy status is unclear, a urine pregnancy test will be offered. Also risk of Lidocaine in pregnancy will be discussed with the patient as currently classified. We will convey that this risk is currently classified as a Risk Class B, which means that animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women. We will also discuss that animal-reproduction studies have shown an decrease in maternal fertility), but that was not confirmed in controlled studies in women in the first trimester and there is no evidence of a risk in later trimesters,
- prior surgery in the hip and lateral leg region
- prior lumbar surgery
- previous pelvic fracture
- previous L1, L2 or L3 lumbar radiculopathy, plexopathy or meralgia paresthetica
- chronic pain syndromes requiring opioid intake
About this study
Official title: A Comparison Between Ultrasound- and Neurostimulation-Guided Lateral Femoral Cutaneous Nerve Block
Background
The sensation on the outside of portion of our thighs is provided by a nerve called the lateral femoral cutaneous nerve (LFCN). The investigators can inject freezing around the nerve to reduce the feeling around the thigh (i.e. anesthesia). Anesthesia, or freezing, of the lateral femoral cutaneous nerve can reduce pain for patients having A) hip and knee surgery [1,2], B) removal of a skin graft [3], and C) wound care. In addition, damage to the LFCN (i.e. Meralgia Paresthetica) has been associated with body armour and gun belt use in military and police personnel [4]. Although generally a benign condition, compression or injury to this nerve can be painful and require treatment. In addition, the actual variability in sensory distribution for this nerve has not been elucidated in a topographical fashion and will be measured in this study.
Finding the most efficient and effective method for anesthesia of the LFCN can improve and positively impact the quality of pain control for patients. Ultrasound has improved the accuracy and efficiency of various other regional anesthesia techniques, and could also impact the safety. Therefore the investigators hypothesize that ultrasound guided lateral femoral cutaneous nerve block using the subinguinal technique will be statistically more efficacious and efficient when compare to neurostimulation based blockade.
Read the detailed description
Purpose of the Study:
The goal of this study is to compare the ultrasound-guided subinguinal injection technique to the neurostimulation-guided injection technique for lateral femoral cutaneous nerve block. The neurostimulation technique uses an electrical field to stimulate the nerve when a needle is close proximity. One older study showed it is better than using landmarks in achieving anesthesia of the lateral femoral cutaneous nerve, but no studies have compared it to using ultrasound to freeze the nerve [7]. The primary outcome will be relative efficiency, i.e. the total anesthesia-related time (defined as the sum of performance and onset times). This is looking at how long it takes for the procedure (needle insertion, medication injection), plus the time it takes for the thigh to go numb. Secondary outcomes will include relative success rate, procedural discomfort, number of needle passes and topographical sensory distribution of this nerve in this cohort of patients .
Methodology:
Selection of Human Subjects:
With the approval of the Defence Research \& Development Canada Human Research Ethics Committee (HREC), a total of 27 volunteers will be recruited. Subjects will be recruited by advertising within the CF Health Services Centre Facility and by email notification to CF members in the National Capital region through the DWAN. If there is insufficient volunteers, those people that have volunteered, will be contacted by email to inquire if they are aware of any other people that maybe be interested in volunteering so that the study can be finalized. If they know if anyone, they will be asked to forward the initial email to those people, asking them to contact the investigator if they wish to have more information. Interested civilian volunteers and Class "A" reservists will be approached from the cohort of patients that responded to the original communication email.
Once patients have submitted their names for consideration, they will be contacted to review whether they meet inclusion/exclusion criteria.
Data Analyses:
the investigators expect the success rates to be similar for both groups. However our hypothesis is that the performance time and the onset time could be different. Therefore the main outcome is the total anesthesia-related time (sum of performance and onset times). According to Shannon et al [7], the total anesthesia-related time for the neurostimulation technique is 10.1 +/- 4.7 min (performance time: 9.5 +/- 4.7 min and onset time: 0.8 +/- 0.9 min). Using a paired T-test to compare both techniques, a difference of 30% in total anesthesia time would represent an effect size of 0.74 and require a total of 17 subjects undergoing bilateral blocks to obtain a 2-tailed α error of 0.05 and a ß error of 0.2. Since onset and total anesthesia-related times can only be measured for successful blocks and since the investigators expect a success rate of 85% for neurostimulation, the investigators will recruit 25 patients to account for those who do not reach the postulated end point.
Normality of the continuous data will first be assessed with the Kolmogorov-Smirnov test. Continuous data will then analyzed using a paired T-test. For categorical data, the Mann-Whitney U test and Chi-square test will be used as appropriate. Hypotheses tested will be 2-tailed. P < 0.05 will be considered statistically significant.
Risks:
Participation in this study will be voluntary and volunteers can withdraw consent at any time without having any effect on access to future medical care. There will likely minor discomfort during the procedure similar to having freezing before a dental procedure or blood drawn. Patients can ask us to stop the procedure at any time. The chance of minor discomfort for up to a day or two after the injection can occur and can be managed with over the counter acetaminophen or ibuprofen. The investigators do not expect any limitations to daily activities.
Furthermore, side effects associated with lateral femoral cutaneous nerve blocks have not been reported and are likely rare. [8].
Confidentiality/Anonymity
Patients' confidentiality/anonymity will be protected through two mechanisms:
- research subjects are identified by serial numbers
- access to patient's research data will be restricted to primary investigators only
Approximate Time Involvement
The approximate time commitment is 1.5 hour.
Roles and Responsibilities of Research Team
Recruitment, study planning and organization will be done by Gaurav Gupta. Technical procedures, data collection and manuscript preparation will be shared tasks by the entire research team.
- Conditions
- Meralgia Paresthetica
- Being tested
- Nerve Injection- Nerve Stimulator, Nerve Injection - Ultrasound
- Keywords
- Lateral Femoral Cutaneous Nerve Block, Meralgia Parasthetica, nerve stimulator, ultrasound
- Medical subject headings
- Femoral Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve Injection- Nerve StimulatorDrug
Also called Lateral Femoral Cutaneous Nerve Block- Neurostimulation
For the neurostimulation nerve injection technique, the initial puncture site will be located medial to the anterosuperior iliac spine, just caudal to the inguinal ligament [7]. The 22-gauge insulated needle will be connected to a stimulator set at a current of 1.5 mA, a pulse width of 300 ms and a frequency of 2 Hz. A paresthesia referred to the lateral aspect of the thigh at a minimal stimulatory threshold of 0.6 mA (0.3ms) will be sought prior to the injection of local anesthetic [7]. A total of 5cc of 2%Xylocaine will be injected for the nerve injection/anesthesia.
Nerve Injection - UltrasoundDrug
Also called Lateral Femoral Cutaneous Nerve Block- Ultrasound
For the ultrasound nerve injection group, after skin disinfection, the inguinal region of patients will be scanned using a high-frequency (6 to 13 MHz) linear array transducer covered with a sterile plastic cover. An ultrasound image showing the inguinal ligament and anterior superior iliac spine (ASIS) will be obtained. Using an out-of-plane technique, a 22-gauge nerve block needle will be inserted 1-2 cm medial to ASIS. The needle will be advanced until its tip rests under the inguinal ligament, immediately ventral to the iliopsoas muscle [6]. A total of 5cc of 2%Xylocaine will be injected for the nerve injection/anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Nerve Stimulation- Xylocaine injection | Experimental | Anesthesia of the lateral femoral cutaneous nerve using local anesthetic will be randomly assigned on the right or left side to receive nerve stimulation-xylocaine or ultrasound guided -xylocaine injections in all patients. One patient will therefore have both nerve stimulation AND ultrasound guided injections, only the side of the injection will be randomly assigned to one of the two modalities. Once one technique has been used to freeze one side, the other side will be frozen using the other technique. Receives: Drug: Nerve Injection- Nerve Stimulator |
| Ultrasound guided Xylocaine injection | Experimental | Anesthesia of the lateral femoral cutaneous nerve using local anesthetic will be randomly assigned on the right or left side to receive nerve stimulation-xylocaine or ultrasound guided -xylocaine injections in all patients. One patient will therefore have both nerve stimulation AND ultrasound guided injections, only the side of the injection will be randomly assigned to one of the two modalities. Once one technique has been used to freeze one side, the other side will be frozen using the other technique. Receives: Drug: Nerve Injection - Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthesia Related Time
The main outcome will be the total anesthesia-related time, defined as the sum of performance and onset times
Measured: less than 30 minutes
Secondary outcomes (3)
Success Rate
percentage of patients with successful block
Measured: less than 30 minutes
Needle Pass
how often needle changes angle to make target
Measured: less than 30 minutes
Pain With Procedure
visual analogue scale- 0-10 - 0 is equal to no pain, while 10 is equal to maximum pain
Measured: less than 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionFeb 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Meralgia ParestheticaStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Forces Health Services Centre Ottawa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaurav Gupta, Canadian Forces Health Services Centre Ottawa
- Investigators
- Gaurav Gupta, MD, Principal investigator, CF Health Centre Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577510
- Sponsor's protocol ID
- #2014-005-
- Status last verified
- Sep 2017
- First submitted
- 14 Oct 2015
- Last updated
- 15 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kim JH, Cho MR, Kim SO, Kim JE, Lee DK, Roh WS. A comparison of femoral/sciatic nerve block with lateral femoral cutaneous nerve block and combined spinal epidural anesthesia for total knee replacement arthroplasty. Korean J Anesthesiol. 2012 May;62(5):448-53. doi: 10.4097/kjae.2012.62.5.448. Epub 2012 May 24.
PubMed 22679542Capdevila X, Biboulet P, Bouregba M, Rubenovitch J, Jaber S. Bilateral continuous 3-in-1 nerve blockade for postoperative pain relief after bilateral femoral shaft surgery. J Clin Anesth. 1998 Nov;10(7):606-9. doi: 10.1016/s0952-8180(98)00097-x.
PubMed 9805704Shteynberg A, Riina LH, Glickman LT, Meringolo JN, Simpson RL. Ultrasound guided lateral femoral cutaneous nerve (LFCN) block: safe and simple anesthesia for harvesting skin grafts. Burns. 2013 Feb;39(1):146-9. doi: 10.1016/j.burns.2012.02.015. Epub 2012 May 30.
PubMed 22657583Fargo MV, Konitzer LN. Meralgia paresthetica due to body armor wear in U.S. soldiers serving in Iraq: a case report and review of the literature. Mil Med. 2007 Jun;172(6):663-5. doi: 10.7205/milmed.172.6.663.
PubMed 17615854Fowler IM, Tucker AA, Mendez RJ. Treatment of meralgia paresthetica with ultrasound-guided pulsed radiofrequency ablation of the lateral femoral cutaneous nerve. Pain Pract. 2012 Jun;12(5):394-8. doi: 10.1111/j.1533-2500.2011.00522.x. Epub 2011 Dec 7.
PubMed 22151457Hara K, Sakura S, Shido A. Ultrasound-guided lateral femoral cutaneous nerve block: comparison of two techniques. Anaesth Intensive Care. 2011 Jan;39(1):69-72. doi: 10.1177/0310057X1103900111.
PubMed 21375093Shannon J, Lang SA, Yip RW, Gerard M. Lateral femoral cutaneous nerve block revisited. A nerve stimulator technique. Reg Anesth. 1995 Mar-Apr;20(2):100-4.
PubMed 7605755Stan TC, Krantz MA, Solomon DL, Poulos JG, Chaouki K. The incidence of neurovascular complications following axillary brachial plexus block using a transarterial approach. A prospective study of 1,000 consecutive patients. Reg Anesth. 1995 Nov-Dec;20(6):486-92.
PubMed 8608066Corujo A, Franco CD, Williams JM. The sensory territory of the lateral cutaneous nerve of the thigh as determined by anatomic dissections and ultrasound-guided blocks. Reg Anesth Pain Med. 2012 Sep-Oct;37(5):561-4. doi: 10.1097/AAP.0b013e318261c8b6.
PubMed 22878522
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Ultrasound- and Neurostimulation-Guided Lateral Femoral Cutaneous Nerve Block
- ClinicalTrials.gov ID
- NCT02577510
- Acronym / sponsor ID
- #2014-005-
- Conditions
- Meralgia Paresthetica
- Keywords
- Lateral Femoral Cutaneous Nerve Block, Meralgia Parasthetica, nerve stimulator, ultrasound
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Canadian Forces Health Services Centre OttawaUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 16 Oct 2015 (estimated)
- Results
- Posted 15 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background
The sensation on the outside of portion of our thighs is provided by a nerve called the lateral femoral cutaneous nerve (LFCN). The investigators can inject freezing around the nerve to reduce the feeling around the thigh (i.e. anesthesia). Anesthesia, or freezing, of the lateral femoral cutaneous nerve can reduce pain for patients having A) hip and knee surgery [1,2], B) removal of a skin graft [3], and C) wound care. In addition, damage to the LFCN (i.e. Meralgia Paresthetica) has been associated with body armour and gun belt use in military and police personnel [4]. Although generally a benign condition, compression or injury to this nerve can be painful and require treatment. In addition, the actual variability in sensory distribution for this nerve has not been elucidated in a topographical fashion and will be measured in this study.
Finding the most efficient and effective method for anesthesia of the LFCN can improve and positively impact the quality of pain control for patients. Ultrasound has improved the accuracy and efficiency of various other regional anesthesia techniques, and could also impact the safety. Therefore the investigators hypothesize that ultrasound guided lateral femoral cutaneous nerve block using the subinguinal technique will be statistically more efficacious and efficient when compare to neurostimulation based blockade.
Detailed description
Purpose of the Study:
The goal of this study is to compare the ultrasound-guided subinguinal injection technique to the neurostimulation-guided injection technique for lateral femoral cutaneous nerve block. The neurostimulation technique uses an electrical field to stimulate the nerve when a needle is close proximity. One older study showed it is better than using landmarks in achieving anesthesia of the lateral femoral cutaneous nerve, but no studies have compared it to using ultrasound to freeze the nerve [7]. The primary outcome will be relative efficiency, i.e. the total anesthesia-related time (defined as the sum of performance and onset times). This is looking at how long it takes for the procedure (needle insertion, medication injection), plus the time it takes for the thigh to go numb. Secondary outcomes will include relative success rate, procedural discomfort, number of needle passes and topographical sensory distribution of this nerve in this cohort of patients .
Methodology:
Selection of Human Subjects:
With the approval of the Defence Research \& Development Canada Human Research Ethics Committee (HREC), a total of 27 volunteers will be recruited. Subjects will be recruited by advertising within the CF Health Services Centre Facility and by email notification to CF members in the National Capital region through the DWAN. If there is insufficient volunteers, those people that have volunteered, will be contacted by email to inquire if they are aware of any other people that maybe be interested in volunteering so that the study can be finalized. If they know if anyone, they will be asked to forward the initial email to those people, asking them to contact the investigator if they wish to have more information. Interested civilian volunteers and Class "A" reservists will be approached from the cohort of patients that responded to the original communication email.
Once patients have submitted their names for consideration, they will be contacted to review whether they meet inclusion/exclusion criteria.
Data Analyses:
the investigators expect the success rates to be similar for both groups. However our hypothesis is that the performance time and the onset time could be different. Therefore the main outcome is the total anesthesia-related time (sum of performance and onset times). According to Shannon et al [7], the total anesthesia-related time for the neurostimulation technique is 10.1 +/- 4.7 min (performance time: 9.5 +/- 4.7 min and onset time: 0.8 +/- 0.9 min). Using a paired T-test to compare both techniques, a difference of 30% in total anesthesia time would represent an effect size of 0.74 and require a total of 17 subjects undergoing bilateral blocks to obtain a 2-tailed α error of 0.05 and a ß error of 0.2. Since onset and total anesthesia-related times can only be measured for successful blocks and since the investigators expect a success rate of 85% for neurostimulation, the investigators will recruit 25 patients to account for those who do not reach the postulated end point.
Normality of the continuous data will first be assessed with the Kolmogorov-Smirnov test. Continuous data will then analyzed using a paired T-test. For categorical data, the Mann-Whitney U test and Chi-square test will be used as appropriate. Hypotheses tested will be 2-tailed. P < 0.05 will be considered statistically significant.
Risks:
Participation in this study will be voluntary and volunteers can withdraw consent at any time without having any effect on access to future medical care. There will likely minor discomfort during the procedure similar to having freezing before a dental procedure or blood drawn. Patients can ask us to stop the procedure at any time. The chance of minor discomfort for up to a day or two after the injection can occur and can be managed with over the counter acetaminophen or ibuprofen. The investigators do not expect any limitations to daily activities.
Furthermore, side effects associated with lateral femoral cutaneous nerve blocks have not been reported and are likely rare. [8].
Confidentiality/Anonymity
Patients' confidentiality/anonymity will be protected through two mechanisms:
- research subjects are identified by serial numbers
- access to patient's research data will be restricted to primary investigators only
Approximate Time Involvement
The approximate time commitment is 1.5 hour.
Roles and Responsibilities of Research Team
Recruitment, study planning and organization will be done by Gaurav Gupta. Technical procedures, data collection and manuscript preparation will be shared tasks by the entire research team.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nerve Stimulation- Xylocaine injection | Experimental | Drug: Nerve Injection- Nerve StimulatorAnesthesia of the lateral femoral cutaneous nerve using local anesthetic will be randomly assigned on the right or left side to receive nerve stimulation-xylocaine or ultrasound guided -xylocaine injections in all patients. One patient will therefore have both nerve stimulation AND ultrasound guided injections, only the side of the injection will be randomly assigned to one of the two modalities. Once one technique has been used to freeze one side, the other side will be frozen using the other technique. |
| Ultrasound guided Xylocaine injection | Experimental | Drug: Nerve Injection - UltrasoundAnesthesia of the lateral femoral cutaneous nerve using local anesthetic will be randomly assigned on the right or left side to receive nerve stimulation-xylocaine or ultrasound guided -xylocaine injections in all patients. One patient will therefore have both nerve stimulation AND ultrasound guided injections, only the side of the injection will be randomly assigned to one of the two modalities. Once one technique has been used to freeze one side, the other side will be frozen using the other technique. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- male and female between 18 and 60 years old
- American Society of Anesthesiologists classification 1-3
Key exclusion criteria (12 listed)
- adults who are unable to give their own consent
- pre-existing neuropathy (assessed by history and physical examination) -
- coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
- renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
- hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
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 |
|---|---|---|
| Nerve Injection- Nerve StimulatorAlso: Lateral Femoral Cutaneous Nerve Block- NeurostimulationFor the neurostimulation nerve injection technique, the initial puncture site will be located medial to the anterosuperior iliac spine, just caudal to the inguinal ligament [7]. The 22-gauge insulated needle will be connected to a stimulator set at a current of 1.5 mA, a pulse width of 300 ms and a frequency of 2 Hz. A paresthesia referred to the lateral aspect of the thigh at a minimal stimulatory threshold of 0.6 mA (0.3ms) will be sought prior to the injection of local anesthetic [7]. A total of 5cc of 2%Xylocaine will be injected for the nerve injection/anesthesia. | Drug | Nerve Stimulation- Xylocaine injection |
| Nerve Injection - UltrasoundAlso: Lateral Femoral Cutaneous Nerve Block- UltrasoundFor the ultrasound nerve injection group, after skin disinfection, the inguinal region of patients will be scanned using a high-frequency (6 to 13 MHz) linear array transducer covered with a sterile plastic cover. An ultrasound image showing the inguinal ligament and anterior superior iliac spine (ASIS) will be obtained. Using an out-of-plane technique, a 22-gauge nerve block needle will be inserted 1-2 cm medial to ASIS. The needle will be advanced until its tip rests under the inguinal ligament, immediately ventral to the iliopsoas muscle [6]. A total of 5cc of 2%Xylocaine will be injected for the nerve injection/anesthesia. | Drug | Ultrasound guided Xylocaine injection |
Primary outcome
Anesthesia Related Time
Time frame: less than 30 minutes
The main outcome will be the total anesthesia-related time, defined as the sum of performance and onset times
3 secondary outcomes
Success Rate
Time frame: less than 30 minutes
Needle Pass
Time frame: less than 30 minutes
Pain With Procedure
Time frame: less than 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22679542Kim JH, Cho MR, Kim SO, Kim JE, Lee DK, Roh WS. A comparison of femoral/sciatic nerve block with lateral femoral cutaneous nerve block and combined spinal epidural anesthesia for total knee replacement arthroplasty. Korean J Anesthesiol. 2012 May;62(5):448-53. doi: 10.4097/kjae.2012.62.5.448. Epub 2012 May 24.
- Background: PubMed 9805704Capdevila X, Biboulet P, Bouregba M, Rubenovitch J, Jaber S. Bilateral continuous 3-in-1 nerve blockade for postoperative pain relief after bilateral femoral shaft surgery. J Clin Anesth. 1998 Nov;10(7):606-9. doi: 10.1016/s0952-8180(98)00097-x.
- Background: PubMed 22657583Shteynberg A, Riina LH, Glickman LT, Meringolo JN, Simpson RL. Ultrasound guided lateral femoral cutaneous nerve (LFCN) block: safe and simple anesthesia for harvesting skin grafts. Burns. 2013 Feb;39(1):146-9. doi: 10.1016/j.burns.2012.02.015. Epub 2012 May 30.
- Background: PubMed 17615854Fargo MV, Konitzer LN. Meralgia paresthetica due to body armor wear in U.S. soldiers serving in Iraq: a case report and review of the literature. Mil Med. 2007 Jun;172(6):663-5. doi: 10.7205/milmed.172.6.663.
- Background: PubMed 22151457Fowler IM, Tucker AA, Mendez RJ. Treatment of meralgia paresthetica with ultrasound-guided pulsed radiofrequency ablation of the lateral femoral cutaneous nerve. Pain Pract. 2012 Jun;12(5):394-8. doi: 10.1111/j.1533-2500.2011.00522.x. Epub 2011 Dec 7.
- Background: PubMed 21375093Hara K, Sakura S, Shido A. Ultrasound-guided lateral femoral cutaneous nerve block: comparison of two techniques. Anaesth Intensive Care. 2011 Jan;39(1):69-72. doi: 10.1177/0310057X1103900111.
- Background: PubMed 7605755Shannon J, Lang SA, Yip RW, Gerard M. Lateral femoral cutaneous nerve block revisited. A nerve stimulator technique. Reg Anesth. 1995 Mar-Apr;20(2):100-4.
- Background: PubMed 8608066Stan TC, Krantz MA, Solomon DL, Poulos JG, Chaouki K. The incidence of neurovascular complications following axillary brachial plexus block using a transarterial approach. A prospective study of 1,000 consecutive patients. Reg Anesth. 1995 Nov-Dec;20(6):486-92.
- Background: PubMed 22878522Corujo A, Franco CD, Williams JM. The sensory territory of the lateral cutaneous nerve of the thigh as determined by anatomic dissections and ultrasound-guided blocks. Reg Anesth Pain Med. 2012 Sep-Oct;37(5):561-4. doi: 10.1097/AAP.0b013e318261c8b6.
- Individual participant dataSharing planned: No
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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.
Gaurav Gupta, MD principal investigator
CF Health Centre Ottawa
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nerve Injection- Nerve Stimulator and Nerve Injection - Ultrasound in people with Meralgia Paresthetica, run by Canadian Forces Health Services Centre Ottawa.
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 2 inclusion and 12 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: finished, as of the sponsor's last update on 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anesthesia Related Time (time frame: less than 30 minutes). 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 NCT02577510, 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 15 Sep 2017.