Zealand University Hospital, Køge
Køge, 4600, Denmark
NCT Number: NCT03138668
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Køge, 4600, Denmark
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: 8 ml Ropivacaine 0.75%
Time frame: 1 hour post-block
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.
Time frame: 1 hour post-block
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.
Time frame: 1 hour post-block
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).
Time frame: 1 hour post-block
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).
Time frame: 1 hour post-block
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.
Time frame: 1 hour post-block
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.
Time frame: 1 hour post-block
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.
Time frame: 1 hour post-block
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.
Time frame: 1 hour post-block
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
Time frame: 1 hour post-block
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.
Zealand University Hospital
Other
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
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