A study in healthy volunteers investigating the effect of injecting local anesthetic on the front of the thigh under ultrasound-guidance in order to anesthetize the skin on the front and medial side of the knee

Selective ultrasound-guided nerve block of the medial femoral cutaneous nerve in healthy volunteers

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004942-12-DK

Enrollment

Registered

2020-10-13

Start date

2020-11-19

Completion date

Unknown

Last updated

2021-03-17

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

Conditions

Pain around the surgical incisions after total knee arthroplasty (TKA). The area anesthetized by new nerve block techniques anesthetizing the medial femoral cutaneous nerve are investigated in healthy volunteers to see if the relevant area around the surgical incision sites are anesthetized. MedDRA version: 21.1 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 100000004865 MedDRA version: 21.0 Level: LLT Classification code 10002325 Term: Anesthesia

Interventions

Trade Name: Marcain-adrenalin Product Name: Bupivacain-adrenalin Pharmaceutical Form: Solution for injection CAS Number: 14252-80-3 Other descriptive name: BUPIVACAINE HYDROCHLORIDE Concentration unit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age = 18 years American Society of Anesthesiologists physical status classification score (ASA) I-II Informed consent 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: Unable to cooperate. Unable to speak or understand Danish Known neuropathy in the extremities Infection in the areas around the injection sites Obesity (Body Mass Index, BMI > 28 kg/m2) Body weight < 60 kg Pregnancy Allergy towards any medical product used in the trial Daily use of medicine except oral contraceptives

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to investigate the success rate of anesthesia of the "gap" (non-anesthetized area) on the surgical incision used for TKA after nerve block of the anterior branch from the medial femoral cutaneous nerve (MFCN) compared to the posterior branch of the MFCN. ;Secondary Objective: The secondary objectives of the trial are to investigate the success rate of complete anesthesia of the surgical incision and of the medial parapatellar incision. Evaluation of the contributions from the different nerves in covering the midline skin incision and the medial parapatellar incision. Evaluation of the anesthetized areas after blockade of the MFCN and of the anterior branch of the MFCN (MFCNant) and posterior branch (MFCNpost). Furthermore muscle strength is evaluated from before to after placement of the blocks. Other secondary objectives include the time used for placement of the MFCN block as well as MFCNant block and an evaluation of the discomfort during nerve block placement. ;Primary end point(s): Success rate of anesthesia of the gap (non-anesthetized area) on the midline incision used for TKA after block of the anterior branch of the MFCN compared to the posterior branch of the MFCN. ;Timepoint(s) of evaluation of this end point: Cutaneous anesthesia is evaluated using pin-prick testing after placement of the last nerve blocks (nerve block round 4)	—

Measure

Time frame

Main Objective: The primary objective is to investigate the success rate of anesthesia of the "gap" (non-anesthetized area) on the surgical incision used for TKA after nerve block of the anterior branch from the medial femoral cutaneous nerve (MFCN) compared to the posterior branch of the MFCN. ;Secondary Objective: The secondary objectives of the trial are to investigate the success rate of complete anesthesia of the surgical incision and of the medial parapatellar incision. Evaluation of the contributions from the different nerves in covering the midline skin incision and the medial parapatellar incision. Evaluation of the anesthetized areas after blockade of the MFCN and of the anterior branch of the MFCN (MFCNant) and posterior branch (MFCNpost). Furthermore muscle strength is evaluated from before to after placement of the blocks. Other secondary objectives include the time used for placement of the MFCN block as well as MFCNant block and an evaluation of the discomfort during nerve block placement. ;Primary end point(s): Success rate of anesthesia of the gap (non-anesthetized area) on the midline incision used for TKA after block of the anterior branch of the MFCN compared to the posterior branch of the MFCN. ;Timepoint(s) of evaluation of this end point: Cutaneous anesthesia is evaluated using pin-prick testing after placement of the last nerve blocks (nerve block round 4)

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Secondary

Measure	Time frame
Secondary end point(s): 1. Success rate of anesthesia of the entire midline incision after block of the anterior branch from MFCN compared to the posterior. 2. Success rate of anesthesia of the gap on the midline skin incision after block of the MFCN (both branches) 3. Which nerves contribute to anesthesia of the midlinje incision 4. Success rate of anesthesia of the entire parapatellar incision after block of the anterior branch of the MFCN compared to the posterior branch of the MFCN. 5. Success rate of anesthesia of the entire parapatellar incision after block of the MFCN (both branches) 6. Hvis nerves contribute to anesthesia of the patapatellar incision 7. Anesthetized area after MFCN block (both branches) 8. Anesthetized area after block of the anterior branch of MFCN 9. Anesthetized area after block of the posterior branch of MFCN 10. Additional anesthetized area after MFCNant block in addition to MFCN block. 11. Change in muscle strength of the quadriceps muscle from baseline to after block of the intermediate femoral cutaneous nerves (IFCN) 12. Change in muscle strength of the quadriceps muscle from after IFCN block to after saphenus nerve block. 13. Change in muscle strength of the quadriceps muscle from after saphenus block placement to after MFCN/MFCNant block 14. Time spent on MFCN block placement defined as the time from the start of ultrasound scanning to withdrawal of the block needle. 15. Time spent on MFCNant block placement defined as the time from the start of ultrasound scanning to withdrawal of the block needle. 16. Discomfort during placement of MFCN block (NRS 0-10) 17. Discomfort during placement of MFCNant block (NRS 0-10) ;Timepoint(s) of evaluation of this end point: Muscle strength test: evaluated at baseline (right after inclusion before any block placement), after the first nerve blocks (IFCNB), after saphenous nerve block and after MFCN/MFCN ant block (nerve block round 3 and 4). Sensation to pin-prick (cutaneous anesthesia):	—

Measure

Time frame

Secondary end point(s): 1. Success rate of anesthesia of the entire midline incision after block of the anterior branch from MFCN compared to the posterior. 2. Success rate of anesthesia of the gap on the midline skin incision after block of the MFCN (both branches) 3. Which nerves contribute to anesthesia of the midlinje incision 4. Success rate of anesthesia of the entire parapatellar incision after block of the anterior branch of the MFCN compared to the posterior branch of the MFCN. 5. Success rate of anesthesia of the entire parapatellar incision after block of the MFCN (both branches) 6. Hvis nerves contribute to anesthesia of the patapatellar incision 7. Anesthetized area after MFCN block (both branches) 8. Anesthetized area after block of the anterior branch of MFCN 9. Anesthetized area after block of the posterior branch of MFCN 10. Additional anesthetized area after MFCNant block in addition to MFCN block. 11. Change in muscle strength of the quadriceps muscle from baseline to after block of the intermediate femoral cutaneous nerves (IFCN) 12. Change in muscle strength of the quadriceps muscle from after IFCN block to after saphenus nerve block. 13. Change in muscle strength of the quadriceps muscle from after saphenus block placement to after MFCN/MFCNant block 14. Time spent on MFCN block placement defined as the time from the start of ultrasound scanning to withdrawal of the block needle. 15. Time spent on MFCNant block placement defined as the time from the start of ultrasound scanning to withdrawal of the block needle. 16. Discomfort during placement of MFCN block (NRS 0-10) 17. Discomfort during placement of MFCNant block (NRS 0-10) ;Timepoint(s) of evaluation of this end point: Muscle strength test: evaluated at baseline (right after inclusion before any block placement), after the first nerve blocks (IFCNB), after saphenous nerve block and after MFCN/MFCN ant block (nerve block round 3 and 4). Sensation to pin-prick (cutaneous anesthesia):

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Countries

Denmark

Contacts

Public ContactSiska Bjørn

Aarhus University

siskabjoern@clin.au.dk+4560651087

Outcome results

None listed

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