Comparing Ways to Freeze the Nerve That Provides Thigh Sensation

NCT02577510 | Completed Phase 3 Results

• 1 other identifier: #2014-005-
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

Meralgia Paresthetica

Keywords

Lateral Femoral Cutaneous Nerve Block; Meralgia Parasthetica; nerve stimulator; ultrasound

Outcome Measures

Primary Outcomes (1)

• Anesthesia Related Time

  The main outcome will be the total anesthesia-related time, defined as the sum of performance and onset times

  less than 30 minutes

Secondary Outcomes (3)

• Success Rate

  less than 30 minutes

• Needle Pass

  less than 30 minutes

• Pain With Procedure

  less than 30 minutes

Study Arms (2)

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.

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.

Drug: Nerve Injection - Ultrasound

Interventions

Nerve Injection- Nerve Stimulator DRUG

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.

Also known as: Lateral Femoral Cutaneous Nerve Block- Neurostimulation

Nerve Stimulation- Xylocaine injection

Nerve Injection - Ultrasound DRUG

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.

Also known as: Lateral Femoral Cutaneous Nerve Block- Ultrasound

Ultrasound guided Xylocaine injection

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• male and female between 18 and 60 years old
• American Society of Anesthesiologists classification 1-3

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Canadian Forces Health Services Centre Ottawa: lead

Related Publications (9)

• 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.

  PMID: 22679542 BACKGROUND

• Capdevila 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.

  PMID: 9805704 BACKGROUND

• Shteynberg 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.

  PMID: 22657583 BACKGROUND

• Fargo 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.

  PMID: 17615854 BACKGROUND

• Fowler 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.

  PMID: 22151457 BACKGROUND

• Hara 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.

  PMID: 21375093 BACKGROUND

• Shannon 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.

  PMID: 7605755 BACKGROUND

• Stan 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.

  PMID: 8608066 BACKGROUND

• Corujo 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.

  PMID: 22878522 BACKGROUND

MeSH Terms

Conditions

Femoral Neuropathy

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Gaurav Gupta
• Organization: CF

gaurav00gupta@gmail.com

6139451601

Study Officials

• Gaurav Gupta, MD

  CF Health Centre Ottawa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD FRCPC

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: October 16, 2015
• Study Start: November 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 15, 2017
• Results First Posted: September 15, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share