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 of the thigh and knee

Ultrasound-guided nerve block of the anterior femoral cutaneous nerves in healthy volunteers

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004986-15-DK

Enrollment

Registered

2019-01-03

Start date

2019-02-18

Completion date

Unknown

Last updated

2020-05-11

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

Conditions

Pain around the surgical incision after total knee arthroplasty (TKA). The area anesthetized by a combination of nerve block techniques anesthetizing the anterior femoral cutaneous nerves are investigated in healthy volunteers to see if the relevant area around the surgical incision site is anesthetized. MedDRA version: 20.0 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 100000004865 MedDRA version: 20.0 Level: LLT Classification code 10002325 Term

Interventions

Trade Name: Ropivacain Product Name: Ropivacain Pharmaceutical Form: Solution for injection/infusion CAS Number: 84057-95-4 Other descriptive name: ROPIVACAINE HYDROCHLORIDE Concentration unit: mg/ml

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 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

Exclusion criteria: Unable to cooperate Unable to speak or understand Danish Known neuropathy in the extremities Chronic, opioid-requiring pain 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to investigate the success rate of complete anesthesia of the surgical incision used for TKA after proximal femoral triangle block (FTB) combined with a block of the intermediate femoral cutaneous nerves (IFCNB) compared to proximal FTB alone. ;Secondary Objective: The secondary objectives of the trial are to investigate the success rate of complete anesthesia of the surgical incision after the different nerve blocks (distal FTB, proximal FTB, IFCNB) alone and in combination. The change in muscle strength is evaluated from before to after placement of the nerve blocks. Moreover the areas anesthetized after proximal FTB and after IFCNB are evaluated and reported as the maximal extension in proximal, distal, medial and lateral direction. Other secondary objectives include the time used for placement of proximal FTB and IFCNB and an evaluation of the discomfort during nerve block placement for each of the different blocks. ;Primary end point(s): Success rate of complete anesthesia of the incision line with active proximal FTB combined with active IFCNB compared to active proximal FTB in combination with placebo IFCNB. ;Timepoint(s) of evaluation of this end point: Cutaneous anesthesia is evaluated using pin-prick testing after: 1) placement of the first four nerve blocks (distal and proximal FTB in each leg). 2) placement of IFCNB in each leg.	—

Measure

Time frame

Main Objective: The primary objective is to investigate the success rate of complete anesthesia of the surgical incision used for TKA after proximal femoral triangle block (FTB) combined with a block of the intermediate femoral cutaneous nerves (IFCNB) compared to proximal FTB alone. ;Secondary Objective: The secondary objectives of the trial are to investigate the success rate of complete anesthesia of the surgical incision after the different nerve blocks (distal FTB, proximal FTB, IFCNB) alone and in combination. The change in muscle strength is evaluated from before to after placement of the nerve blocks. Moreover the areas anesthetized after proximal FTB and after IFCNB are evaluated and reported as the maximal extension in proximal, distal, medial and lateral direction. Other secondary objectives include the time used for placement of proximal FTB and IFCNB and an evaluation of the discomfort during nerve block placement for each of the different blocks. ;Primary end point(s): Success rate of complete anesthesia of the incision line with active proximal FTB combined with active IFCNB compared to active proximal FTB in combination with placebo IFCNB. ;Timepoint(s) of evaluation of this end point: Cutaneous anesthesia is evaluated using pin-prick testing after: 1) placement of the first four nerve blocks (distal and proximal FTB in each leg). 2) placement of IFCNB in each leg.

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Secondary

Measure	Time frame
Secondary end point(s): 1) Change in muscle strength of the quadriceps muscle from baseline to after block placement on the leg with active distal FTB compared to the leg with active proximal FTB. 2) Change in muscle strength of the quadriceps muscle from before IFCNB to after IFCNB on the leg with active distal FTB. 3) Change in muscle strength of the quadriceps muscle from before IFCNB to after IFCNB on the leg with active proximal FTB. 4) Maximal extension of cutaneous anesthesia after distal FTB measured in the proximal, distal, medial and lateral direction. 5) Maximal extension of cutaneous anesthesia after proximal FTB measured in the proximal, distal, medial and lateral direction. 6) Maximal extension of cutaneous anesthesia after IFCNB measured in the proximal, distal, medial and lateral direction. 7) Time spent on distal FTB placement defined as the time from the start of ultrasound scanning to withdrawal of the block needle. 8) Time spent on proximal FTB placement defined as the time from the start of ultrasound scanning to withdrawal of the block needle. 9) Time spent on IFCNB placement defined as the time from the start of ultrasound scanning to withdrawal of the block needle. 10) Discomfort during placement of distal FTB (Numerical rating scale, NRS 0-10). 11) Discomfort during placement of proximal FTB (NRS 0-10). 12) Discomfort during placement of IFCNB (NRS 0-10). 13) Success rate of complete anesthesia of the incision line with distal FTB alone. 14) Success rate of complete anesthesia of the incision line with proximal FTB alone. 15) Success rate of complete anesthesia of the incision line with IFCNB alone on the leg with active distal FTB. 16) Success rate of complete anesthesia of the incision line with distal FTB compared to distal FTB combined with IFCNB. 17) Presence of a gap (defined as a skin area with no anesthesia) involving the incision line 18) Presence of a gap (defined as a skin area with no anesthesia) involving the anteromedial k	—

Measure

Time frame

Secondary end point(s): 1) Change in muscle strength of the quadriceps muscle from baseline to after block placement on the leg with active distal FTB compared to the leg with active proximal FTB. 2) Change in muscle strength of the quadriceps muscle from before IFCNB to after IFCNB on the leg with active distal FTB. 3) Change in muscle strength of the quadriceps muscle from before IFCNB to after IFCNB on the leg with active proximal FTB. 4) Maximal extension of cutaneous anesthesia after distal FTB measured in the proximal, distal, medial and lateral direction. 5) Maximal extension of cutaneous anesthesia after proximal FTB measured in the proximal, distal, medial and lateral direction. 6) Maximal extension of cutaneous anesthesia after IFCNB measured in the proximal, distal, medial and lateral direction. 7) Time spent on distal FTB placement defined as the time from the start of ultrasound scanning to withdrawal of the block needle. 8) Time spent on proximal FTB placement defined as the time from the start of ultrasound scanning to withdrawal of the block needle. 9) Time spent on IFCNB placement defined as the time from the start of ultrasound scanning to withdrawal of the block needle. 10) Discomfort during placement of distal FTB (Numerical rating scale, NRS 0-10). 11) Discomfort during placement of proximal FTB (NRS 0-10). 12) Discomfort during placement of IFCNB (NRS 0-10). 13) Success rate of complete anesthesia of the incision line with distal FTB alone. 14) Success rate of complete anesthesia of the incision line with proximal FTB alone. 15) Success rate of complete anesthesia of the incision line with IFCNB alone on the leg with active distal FTB. 16) Success rate of complete anesthesia of the incision line with distal FTB compared to distal FTB combined with IFCNB. 17) Presence of a gap (defined as a skin area with no anesthesia) involving the incision line 18) Presence of a gap (defined as a skin area with no anesthesia) involving the anteromedial k

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Countries

Denmark

Contacts

Public ContactSiska Bjørn

Aarhus University

siska.bjoern@post.au.dk+4560651087

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 20, 2026