Validating a new nerve block technique with injection of local anaesthetic on the surface of the gluteal muscle

Gluteus medius fascia plane block - Validating a new nerve block technique

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003726-14-DK

Enrollment

Registered

2015-09-11

Start date

2015-10-12

Completion date

Unknown

Last updated

2020-11-03

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

Conditions

Hip fracture MedDRA version: 18.0 Level: LLT Classification code 10017284 Term: Fractured femoral neck System Organ Class: 100000004863

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Age = 18 years -Mentally capable of cooperating during the trial. -ASA i or II - Written informed consent - Understanding and speaking Danish or English. -No anatomical og technical issues that could make nerve block in the hip region impossible. 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 11 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1

Exclusion criteria

Exclusion criteria: -Allergy to local anaesthetics -Current pregnancy -Weight less than 50 kg -Infection in the area of injection

Design outcomes

Primary

Measure	Time frame
Main Objective: Validation of a new nerve block technique, the Gluteus Medius Fascia Plane Block(GMFPB) in order to improver the postoperative analgesia in patients with hip fracture.;Secondary Objective: Success rates of variations of the nerve block (Supplement of a secondary injection of local anaesthetic in a more superficial layer, GMFPB+ and the secondary injection alone, SI) Description of the anaesthetized skin area after GMFPB, GMFPB+ and SI. Duration of effect of GMFPB, GMFPB+ and SI.;Primary end point(s): -Success rate of anaesthetizing the skin on the lateral side of the hip in the level of the greater trochanter of the femur all the way distal to the innervated skin area of the lateral femoral cutaneous nerve after GMFPB compared to placebo.;Timepoint(s) of evaluation of this end point: 140 minutes	—

Measure

Time frame

Main Objective: Validation of a new nerve block technique, the Gluteus Medius Fascia Plane Block(GMFPB) in order to improver the postoperative analgesia in patients with hip fracture.;Secondary Objective: Success rates of variations of the nerve block (Supplement of a secondary injection of local anaesthetic in a more superficial layer, GMFPB+ and the secondary injection alone, SI) Description of the anaesthetized skin area after GMFPB, GMFPB+ and SI. Duration of effect of GMFPB, GMFPB+ and SI.;Primary end point(s): -Success rate of anaesthetizing the skin on the lateral side of the hip in the level of the greater trochanter of the femur all the way distal to the innervated skin area of the lateral femoral cutaneous nerve after GMFPB compared to placebo.;Timepoint(s) of evaluation of this end point: 140 minutes

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Secondary

Measure	Time frame
Secondary end point(s): -Success rate of anaesthetizing the skin on the lateral side of the hip in the level of the greater trochanter of the femur all the way distal to the innervated skin area of the lateral femoral cutaneous nerve after GMFPB compared to SI- -The total, anterior, posterior and cranial area anaesthetized after GMFPB compared to SI --Success rate of anaesthetizing the skin on the lateral side of the hip in the level of the greater trochanter of the femur all the way distal to the innervated skin area of the lateral femoral cutaneous nerve after GMFPB compared to GMFPB+ --The total, anterior, posterior and cranial area anaesthetized after GMFPB compared to SI -Mean distance from most cranial part of the skin area anaethetized after Lateral Femoral Cutaneous Nerve(LFCN) block to the greater trochanter of the femur at the level of latter - Mean distance from the most distal part of the skin areas anaesthetized by GMFPB, GMFPB+ and SI to the most cranial part of the skin area anaethetized after LFCN block at the level of the greater trochanter in the cases where these areas do not overlap. -Mean distance from the most distal part of the skin areas anaesthetized by GMFPB, GMFPB+ and SI to the greater trochanter of the femur at the level of the greater trochanter in the cases where the skin areas do not overlap with the skin area anesthetized after LFCN block . - Duration of effect;Timepoint(s) of evaluation of this end point: 30 minutes 250 minutes 360 minutes 24 hours	—

Measure

Time frame

Secondary end point(s): -Success rate of anaesthetizing the skin on the lateral side of the hip in the level of the greater trochanter of the femur all the way distal to the innervated skin area of the lateral femoral cutaneous nerve after GMFPB compared to SI- -The total, anterior, posterior and cranial area anaesthetized after GMFPB compared to SI --Success rate of anaesthetizing the skin on the lateral side of the hip in the level of the greater trochanter of the femur all the way distal to the innervated skin area of the lateral femoral cutaneous nerve after GMFPB compared to GMFPB+ --The total, anterior, posterior and cranial area anaesthetized after GMFPB compared to SI -Mean distance from most cranial part of the skin area anaethetized after Lateral Femoral Cutaneous Nerve(LFCN) block to the greater trochanter of the femur at the level of latter - Mean distance from the most distal part of the skin areas anaesthetized by GMFPB, GMFPB+ and SI to the most cranial part of the skin area anaethetized after LFCN block at the level of the greater trochanter in the cases where these areas do not overlap. -Mean distance from the most distal part of the skin areas anaesthetized by GMFPB, GMFPB+ and SI to the greater trochanter of the femur at the level of the greater trochanter in the cases where the skin areas do not overlap with the skin area anesthetized after LFCN block . - Duration of effect;Timepoint(s) of evaluation of this end point: 30 minutes 250 minutes 360 minutes 24 hours

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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