Zealand University Hospital, Køge
Køge, 4600, Denmark
NCT Number: NCT02957903
The purpose of this study is to investigate and describe the anatomical distribution of the sensory outcome following LFCN block (LFCN = lateral femoral cutaneous nerve) in relation to the incisional lines after Total Hip Arthroplasty (THA). Furthermore, is the aim to examine whether there is a motorial outcome corresponding to the Femoral nerve. The trial will be conducted in healthy volunteers in a blinded, randomized paired study.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
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. LFCN is purely sensorial and can therefore relieve the patient of pain without influencing the early mobilization. In addition, the application of nerve blocks is very easy and virtually without complications.
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. It is therefore relevant to describe the anatomical distribution of a LFCN block in order to determine whether the variations in anatomy is a contributing factor of the high number of patients with no effect of the blockade.
An earlier study investigated the proportion of the incisional line associated with total hip arthroplasty that was covered by the LFCN block. However the study was not blinded or randomized, and the description of the anatomical distribution of the block was inadequate.
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 a pain stimulation test with determination of the heat pain threshold (Heat Pain Detection Threshold, HPDT) and pain during tonic heat-stimulation of the skin (VAS tonic heat stimulation). The duration and distribution of the sensory block is thus evaluated by high precision.
It is furthermore important to investigate whether the nerve blockade affects N. Femoralis' motorial innervation by testing m.Quadriceps' motorial function.
Course of study:
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.
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 A and B in form of a nerve block injection around the lateral femoral cutaneous nerve. Treatment A and B will be randomized to be given in either right or left lower extremity. If the participant is randomized to receive treatment A in the right lower extremity, treatment B 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 %
All 20 study participants will receive both treatment A and B in form of a nerve block injection around the lateral femoral cutaneous nerve. Treatment A and B will be randomized to be given in either right or left lower extremity. If the participant is randomized to receive treatment A in the right lower extremity, treatment B will be given in the left lower extremity, and vice versa. Each participant will thus constitute as their own control.
Other names: 8 ml isotonic Saline
Time frame: 1 hour post-block
Difference in the percentage coverage of the incision (posterior approach) between the side given Ropivacaine versus the side given saline assessed by cold sensation with alcohol soaked gauze.
Time frame: 1 hour post-block
Difference in the percentage coverage of the incision (anterior-lateral approach) between the side given Ropivacaine versus the side given saline assessed by cold sensation with alcohol soaked gauze.
Time frame: 1 hour post-block
Difference in the percentage coverage of the incision (posterior approach) between the side given Ropivacaine versus the side given saline assessed by pin-prick (Von Frey filament).
Time frame: 1 hour post-block
Difference in the percentage coverage of the incision (anterior-lateral approach) between the side given Ropivacaine versus the side given saline assessed by pin-prick (Von Frey filament).
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 versus the side given saline.
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 versus the side given saline.
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 (anterior-lateral approach) on the side given Ropivacaine versus the side given saline.
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 (anterior-lateral approach) on the side given Ropivacaine versus the side given saline.
Time frame: 1 hour post-block
The percentage of patients with no sensory function (no pain detection) assessed by Heat pain detection threshold test on the most superior part of the incision (posterior approach) on the side given Ropivacaine versus the side given saline.
Time frame: 1 hour post-block
The percentage of patients with no sensory function (no pain detection) assessed by Heat pain detection threshold test on the most inferior part of the incision (posterior approach) on the side given Ropivacaine versus the side given saline.
Time frame: 1 hour post-block
The percentage of patients with no sensory function (no pain detection) assessed by Heat pain detection threshold test on the most superior part of the incision (anterior-lateral approach) on the side given Ropivacaine versus the side given saline.
Time frame: 1 hour post-block
The percentage of patients with no sensory function (no pain detection) assessed by Heat pain detection threshold test on the most inferior part of the incision (anterior-lateral approach) on the side given Ropivacaine versus the side given saline.
Time frame: 1 hour post-block
Estimation of the area with sensory loss (including photo documentation) assessed by cold sensation (alcohol soaked gauze) on the side given Ropivacaine and the side given saline. Marked with the incisions.
Time frame: 1 hour post-block
Estimation of the area with sensory loss (including photo documentation) assessed by pin-prick (Von Frey filament) on the side given Ropivacaine and the side given saline. Marked with the incisions.
Time frame: 1 hour post-block
The difference in MVIC (maximal voluntary isometric contraction) of the leg between the side given Ropivacaine versus the side given saline.
Zealand University Hospital
Other
Sensory Distribution of Lateral Femoral Cutaneous Nerve Block - A Randomized, Blinded, Paired Trial in Healthy Volunteers
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