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Nerve BlockPhase 2NCT03138668

Cutaneous Anesthesia of the Lateral Femoral Cutaneous Nerve

A Phase 2 study testing Ropivacaine Injection in people with Nerve Block and Anesthesia, Local, run by Zealand University Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to investigate and describe the anatomical differences in distribution of the blocked area following a perineural LFCN (Lateral Femoris Cutaneous Nerve) block with either 8 ml or 16 ml of Ropivacaine, in relation to incision lines used in THA (Total Hip Arthroplasty). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Ropivacaine Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteDenmark
Study dates
19 May 2017to 9 Jun 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participant who have given their written consent after understanding the content and limitations of the study.
  • ASA 1-2
  • BMI ≥ 18 or ≤ 30

Who cannot join

  • Participants who can not cooperate in the study.
  • Participants who can not speak or understand danish.
  • Allergies to the drugs used in the study.
  • Alcohol abuse, by the investigators judgement.
  • Drug abuse, by the investigators judgement.
  • Daily use of prescription required analgesic drugs within the last four weeks.
Show all 12Show fewer
  • Consumption of over the counter analgesic drugs within the last 48 hours.
  • Neuromuscular defects, former surgery or trauma to the lower extremities. (Hip to knee)
  • Broken skin or wounds on the lower extremities, that could be hindering in the evaluation of the anatomical distribution of the LFCN block.
  • Diabetes Mellitus.
  • Pregnant women (women in the fertile age must be using safe contraception and produce a negative urine-HCG test to be able to participate in the study).
  • Large tattoos in the examination area.

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Zealand University Hospital, Køge

    Køge, 4600

Other trials in Denmark

About this study

Official title: The Influence of Different Doses of Local Anesthetic on the Distribution of Anesthesia of the Lateral Femoral Cutaneous Nerve - a Randomized, Blinded, Paired Study of Healthy Individuals

The purpose of this study is to investigate and describe the anatomical differences in distribution of the blocked area following a perineural LFCN (Lateral Femoris Cutaneous Nerve) block with either 8 ml or 16 ml of Ropivacaine, in relation to incision lines used in THA (Total Hip Arthroplasty). Furthermore, we examine any loss of motor function in Musculus Quadriceps due to posible involvement of the Femoral Nerve. This trial will be conducted in healthy volunteers, as a blinded, randomized, paired trial.

Read the detailed description

Background:

Total hip arthroplasties may be associated with moderate to intense postoperative pain. It is essential that pain treatment, besides being analgesic, has a minimum of side effects, especially those opioid-related, in order to achieve low morbidity, high patient satisfaction and to encourage the functional rehabilitation.

Currently, there is no "gold standard" for pain treatment after THA, and there exists a large variety of treatment options. Some patients who have undergone THA, can be difficult to sufficiently treat with conventional analgesics without reaching additional morphine doses where side effects are unacceptable. It is therefore important to explore other treatment options, including nerve blockade.

Nerve blocks have previously been used after THA operations, but have been hampered by the fact, that the nerve blocks have an effect on the motorial nerve, inhibiting early mobilization and possibly increasing tendencies to fall when mobilized. The Lateral Femoral Cutaneous Nerve (LFCN) is purely sensorial and can therefore relieve the patient of pain without influencing the early mobilization.

In two previous trials, the investigators have studied the effect of LFCN blocks in pain treatment after THA. In the recent study, the LFCN block was applied in patients after THA, who still had visual analogue scale (VAS) mobilization pain > 40 mm when lifting their leg stretched. The LFCN block alleviated significantly the average pain at group level. Meanwhile 42% of patients in the study had no or limited effect of the block. The reason for this may be due to the fact, that LFCN block does not cover all types of pain after THA, but also the fact, that the nerve innervation area has individual differences in the anatomical distribution. We are currently investigating this matter in another study.

LFCN arise from the lumbar plexus, L1-L3. It progresses profound to m. psoas major and over m. iliacus towards the anterior superior iliac spine (ASIS). LFCN perforates the inguinal ligament in varying distance from the ASIS. Afterwards it makes a roughly 90 degrees lateral turn, divides into 3-5 branches and innervates skin lying on the lateral, proximal part of the leg. LFCN is found to have multiple anatomical variations therefore it is described to innervate both the lateral, as well as the anterior, parts of the thigh.

A single study has described LFCN as being placed in it's own canal created by a splitting of the Iliac Fascia creating a lumen in which the nerve lies. Therefore, it is hypothesized that a larger injection volume of local anaesthetic could migrate both proximal and distal within the above-described canal, spreading to additional local cutaneous nerves arising from LFCN, or even other nerves (iliohypogastric, ilioinguinal or subcostal), thereby giving rise to a greater blocked distribution area. An unwanted result of a larger injection volume is the possibility of involvement of the femoral nerve, which would result in motoric blockage of the Quadriceps muscle. It has previously been described that Iliac fascia block (injection profound to the iliaca fascia) has a great diversity in area distribution as well as blockage of the femoral nerve. By injecting the local anaesthetic directly into LFCN own canal we seek to minimize the risk of femoral nerve involvement.

Methods:

Prior to applying the nerve block, the measurement methods are tested and baseline values are registered for each leg of each participant.

The effect of a nerve block in healthy individuals can be studied by a number of validated measurement techniques. These techniques consist of mapping the affected anatomical area with temperature discrimination test (cold sensation) by using alcohol soaked gauze and pin-prick test by using a Von Frey filament, and of pain during tonic heat-stimulation of the skin (VAS tonic heat stimulation). The distribution of the sensory block is thus evaluated by high precision.

It is furthermore important to investigate whether the nerve blockade affects the femoral nerve's motorial innervation by testing m.Quadriceps' motoric function.

Course of study:

  1. Baseline values are measured.
  2. An orthopedic surgeon draws two hypothetical incisional lines corresponding to the posterior and to the anterior-lateral access to the hip joint on each leg of each participant. The incisional lines will be drawn with UV paint only visible under UV light. No other than the person drawing the lines and the participant will see where the lines are drawn.
  3. An ultrasound guided LFCN block is then applied by a doctor with extensive experience in applying ultrasound guided blocks. Each trial participant will get two injection of Ropivacaine 0.75%. 8 ml in one leg and 16 ml in the other leg. Neither trial participants, doctors,investigator or outcome assessors will know which volume the participant receives in which leg, that is the trial is blinded.
  4. After the LFCN block is applied a line called "Line A" is drawn on each leg. Line A goes from trochanter major to the femoral lateral epicondyle and is extended cranial. A line 0A is drawn perpendicular on line A at the trochanter major point. 5 cm above line 0A, is line -1A drawn up to -3A, and 5 cm below line 0A is line 1A drawn, and so forth to line 15A is reached.
  5. One hour after the nerve block is applied to the right leg, the motorial and sensorial tests will be carried out on each leg, and the outcome will be registered and documented with photography. The test will be carried out on the right leg and then on the left leg in following order:
  • Maximum isometric voluntary contraction
  • Temperature discrimination test (alcohol soaked gauze)
  • Pin-prick (Von Frey filament)
  • Photo documentation
  • Drawing of the incisional lines under UV-light
  • Photo documentation
  • Measurement of the incisional lines
  • Pain stimulation test. The subjects will be monitored with blood pressure, pulse oximetry and ECG during the trial. The study extends for each participant from the introductory conversation to all testing is complete.
Being tested
Ropivacaine Injection
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ropivacaine InjectionDrug

    Also called 8 ml Ropivacaine 0.75%

    All 20 study participants will receive both treatment "Low dose Ropivacaine" and "High dose Ropivacaine" in form of a nerve block injection around the lateral femoral cutaneous nerve. Treatment "Low dose Ropivacaine" and "High dose Ropivacaine" will be randomized to be given in either right or left lower extremity. If the participant is randomized to receive treatment "Low dose Ropivacaine" in the right lower extremity, treatment "High dose Ropivacaine" will be given in the left lower extremity, and vice versa. Each participant will thus constitute as their own control.

  • Ropivacaine InjectionDrug

    Also called 16 ml Ropivacaine 0.75%

    All 20 study participants will receive both treatment "Low dose Ropivacaine" and "High dose Ropivacaine" in form of a nerve block injection around the lateral femoral cutaneous nerve. Treatment "Low dose Ropivacaine" and "High dose Ropivacaine" will be randomized to be given in either right or left lower extremity. If the participant is randomized to receive treatment "Low dose Ropivacaine" in the right lower extremity, treatment "High dose Ropivacaine" will be given in the left lower extremity, and vice versa. Each participant will thus constitute as their own control.

Study groups in NCT03138668
Study groupRoleWhat they receive
Low dose RopivacaineExperimentalPerineural injection of 8 ml of Ropivacaine 0.75% at the lateral femoral cutaneous nerve
Receives: Drug: Ropivacaine Injection
High dose RopivacaineExperimentalPerineural injection of 16 ml of Ropivacaine 0.75% at the lateral femoral cutaneous nerve.
Receives: Drug: Ropivacaine Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in the percentage coverage of the incision (posterior approach) assessed by cold sensation with an alcohol swab.

    Difference in the percentage coverage of the incision (posterior approach) between the side given ropivacaine, 16 ml, versus the side given ropivacaine, 8 ml, assessed by cold sensation with an alcohol swab.

    Measured: 1 hour post-block

Secondary outcomes (9)
  1. Difference in the percentage coverage of the incision (anterolateral approach) assessed by cold sensation with an alcohol swab.

    Difference in the percentage coverage of the incision (anterolateral approach) between the side given ropivacaine, 16 ml, versus the side given ropivacaine, 8 ml, assessed by cold sensation with an alcohol swab.

    Measured: 1 hour post-block

  2. Difference in the percentage coverage of the incision (posterior approach) assessed by pinprick (von frey).

    Difference in the percentage coverage of the incision (posterior approach) between the side given ropivacaine, 16 ml, versus the side given ropivacaine, 8 ml, assessed by pinprick (von frey).

    Measured: 1 hour post-block

  3. Difference in the percentage coverage of the incision (anterolateral approach) assessed by pinprick (von frey).

    Difference in the percentage coverage of the incision (anterolateral approach) between the side given ropivacaine, 16 ml, versus the side given ropivacaine, 8 ml, assessed by pinprick (von frey).

    Measured: 1 hour post-block

  4. The percentage of patients with no sensory function assessed by Maximum pain during tonic heat stimulation test on the most superior part of the incision (posterior approach)

    The percentage of patients with no sensory function (VAS = 0) assessed by Maximum pain during tonic heat stimulation test on the most superior part of the incision (posterior approach) on the side given ropivacaine, 16 ml, versus the side given ropivacaine, 8 ml.

    Measured: 1 hour post-block

  5. The percentage of patients with no sensory function assessed by Maximum pain during tonic heat stimulation test on the most inferior part of the incision (posterior approach)

    The percentage of patients with no sensory function (VAS = 0) assessed by Maximum pain during tonic heat stimulation test on the most inferior part of the incision (posterior approach) on the side given ropivacaine, 16 ml, versus the side given ropivacaine, 8 ml.

    Measured: 1 hour post-block

  6. The percentage of patients with no sensory function assessed by Maximum pain during tonic heat stimulation test on the most superior part of the incision (anterolateral approach)

    The percentage of patients with no sensory function (VAS = 0) assessed by Maximum pain during tonic heat stimulation test on the most superior part of the incision (anterolateral approach) on the side given ropivacaine, 16 ml, versus the side given ropivacaine, 8 ml.

    Measured: 1 hour post-block

  7. The percentage of patients with no sensory function assessed by Maximum pain during tonic heat stimulation test on the most inferior part of the incision (anterolateral approach)

    The percentage of patients with no sensory function (VAS = 0) assessed by Maximum pain during tonic heat stimulation test on the most inferior part of the incision (anterolateral approach) on the side given ropivacaine, 16 ml, versus the side given ropivacaine, 8 ml.

    Measured: 1 hour post-block

  8. Estimation of the areal of the sensory loss

    Estimation of the areal of the sensory loss (including photodocumentation) on the side given ropivacaine, 16 ml, versus the side given ropivacaine, 8 ml. Marked with the incisions

    Measured: 1 hour post-block

  9. The difference in MVIC of the knee joint

    The difference in MVIC (maximal voluntary isometric contraction) of the knee joint between the side given ropivacaine, 16 ml, versus the side given ropivacaine, 8 ml compared to pre-block values.

    Measured: 1 hour post-block

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2017
  2. Study start19 May 2017
  3. Primary completion9 Jun 2017
  4. Study completion9 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03138668
Sponsor's protocol ID
SM2-KHT-2016
Other IDs
2016-004936-39, 2016
Status last verified
Mar 2017
First submitted
1 May 2017
Last updated
14 Jun 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: If data is requested by an editor, it will be allowed.

Publications

  • Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.

    PubMed 23392233
  • Kehlet H, Dahl JB. Anaesthesia, surgery, and challenges in postoperative recovery. Lancet. 2003 Dec 6;362(9399):1921-8. doi: 10.1016/S0140-6736(03)14966-5.

    PubMed 14667752
  • Hojer Karlsen AP, Geisler A, Petersen PL, Mathiesen O, Dahl JB. Postoperative pain treatment after total hip arthroplasty: a systematic review. Pain. 2015 Jan;156(1):8-30. doi: 10.1016/j.pain.0000000000000003.

    PubMed 25599296
  • Fischer HB, Simanski CJ. A procedure-specific systematic review and consensus recommendations for analgesia after total hip replacement. Anaesthesia. 2005 Dec;60(12):1189-202. doi: 10.1111/j.1365-2044.2005.04382.x.

    PubMed 16288617
  • Thybo KH, Schmidt H, Hagi-Pedersen D. Effect of lateral femoral cutaneous nerve-block on pain after total hip arthroplasty: a randomised, blinded, placebo-controlled trial. BMC Anesthesiol. 2016 Mar 23;16:21. doi: 10.1186/s12871-016-0183-4.

    PubMed 27006014
  • Thybo KH, Mathiesen O, Dahl JB, Schmidt H, Hagi-Pedersen D. Lateral femoral cutaneous nerve block after total hip arthroplasty: a randomised trial. Acta Anaesthesiol Scand. 2016 Oct;60(9):1297-305. doi: 10.1111/aas.12764. Epub 2016 Jul 18.

    PubMed 27426231
  • Doklamyai P, Agthong S, Chentanez V, Huanmanop T, Amarase C, Surunchupakorn P, Yotnuengnit P. Anatomy of the lateral femoral cutaneous nerve related to inguinal ligament, adjacent bony landmarks, and femoral artery. Clin Anat. 2008 Nov;21(8):769-74. doi: 10.1002/ca.20716.

    PubMed 18942079
  • Surucu HS, Tanyeli E, Sargon MF, Karahan ST. An anatomic study of the lateral femoral cutaneous nerve. Surg Radiol Anat. 1997;19(5):307-10. doi: 10.1007/BF01637599.

    PubMed 9413078
  • Grothaus MC, Holt M, Mekhail AO, Ebraheim NA, Yeasting RA. Lateral femoral cutaneous nerve: an anatomic study. Clin Orthop Relat Res. 2005 Aug;(437):164-8. doi: 10.1097/01.blo.0000164526.08610.97.

    PubMed 16056045
  • Dimitropoulos G, Schaepkens van Riempst J, Schertenleib P. Anatomical variation of the lateral femoral cutaneous nerve: a case report and review of the literature. J Plast Reconstr Aesthet Surg. 2011 Jul;64(7):961-2. doi: 10.1016/j.bjps.2010.11.020. Epub 2011 Jan 3.

    PubMed 21208836
  • Davies A, Crossley A, Harper M, O'Loughlin E. Lateral cutaneous femoral nerve blockade-limited skin incision coverage in hip arthroplasty. Anaesth Intensive Care. 2014 Sep;42(5):625-30. doi: 10.1177/0310057X1404200513.

    PubMed 25233177
  • 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.

    PubMed 22878522
  • Tomaszewski KA, Popieluszko P, Henry BM, Roy J, Sanna B, Kijek MR, Walocha JA. The surgical anatomy of the lateral femoral cutaneous nerve in the inguinal region: a meta-analysis. Hernia. 2016 Oct;20(5):649-57. doi: 10.1007/s10029-016-1493-7. Epub 2016 Apr 26.

    PubMed 27115766
  • Rudin D, Manestar M, Ullrich O, Erhardt J, Grob K. The Anatomical Course of the Lateral Femoral Cutaneous Nerve with Special Attention to the Anterior Approach to the Hip Joint. J Bone Joint Surg Am. 2016 Apr 6;98(7):561-7. doi: 10.2106/JBJS.15.01022.

    PubMed 27053584
  • Hanna A. The lateral femoral cutaneous nerve canal. J Neurosurg. 2017 Mar;126(3):972-978. doi: 10.3171/2016.1.JNS152262. Epub 2016 Apr 22.

    PubMed 27104839

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ropivacaine Injection in people with Nerve Block and Anesthesia, Local, run by Zealand University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in the percentage coverage of the incision (posterior approach) assessed by cold sensation with an alcohol swab. (time frame: 1 hour post-block). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03138668, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017; AzTrials last refreshed its copy on 8 Nov 2026.

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