The lateral femoral cutaneous nerve – description of the sensory territory and a novel ultrasound guided nerve block technique

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003213-98-DK

Enrollment

Unknown

Registered

2016-08-17

Start date

2016-10-14

Completion date

Unknown

Last updated

2017-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MedDRA version: 19.0 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 100000004865

Interventions

Trade Name: Marcain Product Name: Marcain Pharmaceutical Form: Solution for injection INN or Proposed INN: Bupivacain Other descriptive name: BUPIVACAINE HYDROCHLORIDE Concentration unit: mg/ml millig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age = 18 years - Written informed consent - ASA i or II -Mentally capable of cooperating during the trial. - Understanding and speaking Danish or English. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Pre-existing neurological pathology involving the area of investigation - Anatomical or mental aspects that would hinder nerve blocks - Allergy to local anesthetics - Current pregnancy - Weight less than 60 kg - Request to leave the trial - Infection in the area of injection

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the success rate of a novel ultrasound guided nerve block technique of the lateral femoral cutaneous nerve(LFCN) in anesthetizing the proximal area of cutaneous sensory innervation of this nerve.;Secondary Objective: Presenting a novel nerve block technique Evaluating the area of cutaneous sensory innervation of the LFCN;Primary end point(s): Success rate of anesthesia in the proximal area of the cutaneous sensory innervation of the LFCN after a novel LFCN-nerve block (NB) compared to placebo. The primary endpoint is measured on a straight line through the greater trochanter and the lateral patella (TMP-line) The area of cutaneous sensory innervation is defined by the proximal and lateral area anesthetized by a supra-inguinal fascia iliaca compartment block(FICB).;Timepoint(s) of evaluation of this end point: 30 minutes	—

Measure

Time frame

Main Objective: To evaluate the success rate of a novel ultrasound guided nerve block technique of the lateral femoral cutaneous nerve(LFCN) in anesthetizing the proximal area of cutaneous sensory innervation of this nerve.;Secondary Objective: Presenting a novel nerve block technique Evaluating the area of cutaneous sensory innervation of the LFCN;Primary end point(s): Success rate of anesthesia in the proximal area of the cutaneous sensory innervation of the LFCN after a novel LFCN-nerve block (NB) compared to placebo. The primary endpoint is measured on a straight line through the greater trochanter and the lateral patella (TMP-line) The area of cutaneous sensory innervation is defined by the proximal and lateral area anesthetized by a supra-inguinal fascia iliaca compartment block(FICB).;Timepoint(s) of evaluation of this end point: 30 minutes

—

Secondary

Measure	Time frame
Secondary end point(s): - Mean distance from the proximal anesthetized area after NB to the proximal anesthetized area after FICB, measured on the TMP-line. - Mean distance from the proximal anesthetized area after NB to the proximal part of the greater trochanter, measured on the TMP-line. - Mean distance from the proximal anesthetized area after FICB to the proximal part of the greater trochanter, measured on the TMP-line. - Mean distance from the distal anesthetized area after NB to the joint line between femur and tibia - Mean distance from the distal anesthetized area after FICB to the joint line between femur and tibia, on the lateral side of the thigh -Succes rate of the anesthetized area of the NB to completely cover the lines for each of the incisions: Pins, dynamic hip screws, intramedullary nail (3 incisions), anterior approach, anterolateral approach, lateral approach and posterior approach. -Succes rate of the anesthetized area of the NB to partly cover the lines for each of the incisions: Pins, dynamic hip screws, intramedullary nail (3 incisions), anterior approach, anterolateral approach, lateral approach and posterior approach. -Failure rate of the anesthetized area of the NB of covering any part of the lines for each of the incisions: Pins, dynamic hip screws, intramedullary nail (3 incisions), anterior approach, anterolateral approach, lateral approach and posterior approach. - Success rate of the anesthetized after the FICB to completely cover the distal incision for intramedullary nail. - Success rate of the anesthetized area after NB to cross an anterior midline(ASIS-P-line) through the anterior superior iliac spine (ASIS) and the central patella. - Mean distance from the medial-most part of the anesthetized area after the NB to the ASIS-P-line. - Mean maximal-distance measured perpendicular from the TMP-line to the medial part of the anesthetized area after NB - Mean maximal-distance measured perpendicular from the TMP-line to the lateral part	—

Measure

Time frame

Secondary end point(s): - Mean distance from the proximal anesthetized area after NB to the proximal anesthetized area after FICB, measured on the TMP-line. - Mean distance from the proximal anesthetized area after NB to the proximal part of the greater trochanter, measured on the TMP-line. - Mean distance from the proximal anesthetized area after FICB to the proximal part of the greater trochanter, measured on the TMP-line. - Mean distance from the distal anesthetized area after NB to the joint line between femur and tibia - Mean distance from the distal anesthetized area after FICB to the joint line between femur and tibia, on the lateral side of the thigh -Succes rate of the anesthetized area of the NB to completely cover the lines for each of the incisions: Pins, dynamic hip screws, intramedullary nail (3 incisions), anterior approach, anterolateral approach, lateral approach and posterior approach. -Succes rate of the anesthetized area of the NB to partly cover the lines for each of the incisions: Pins, dynamic hip screws, intramedullary nail (3 incisions), anterior approach, anterolateral approach, lateral approach and posterior approach. -Failure rate of the anesthetized area of the NB of covering any part of the lines for each of the incisions: Pins, dynamic hip screws, intramedullary nail (3 incisions), anterior approach, anterolateral approach, lateral approach and posterior approach. - Success rate of the anesthetized after the FICB to completely cover the distal incision for intramedullary nail. - Success rate of the anesthetized area after NB to cross an anterior midline(ASIS-P-line) through the anterior superior iliac spine (ASIS) and the central patella. - Mean distance from the medial-most part of the anesthetized area after the NB to the ASIS-P-line. - Mean maximal-distance measured perpendicular from the TMP-line to the medial part of the anesthetized area after NB - Mean maximal-distance measured perpendicular from the TMP-line to the lateral part

—

Countries

Denmark

Contacts

Public ContactDep. Anaesthesia and Intensive Care

Aarhus University Hospital

thomas.dahl.nielsen@clin.au.dk+4528782877

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026