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To investigate the function of a novel catheter for continuous peripheral nerve blocks in the popliteal nerve: Two key issues are investigated 1) Successful primary placement and function of the catheter for continuous peripheral nerve blocks confirmed by a decrease in motor function following injection of local analgesics through the catheter; 2) The rate of displacement after standardized movement of the limb where the catheter for continuous peripheral nerve blocks is inserted.
Although peripheral nerve blocks are known to provide superior postoperative analgesia. Continuous peripheral nerve block (CPNB) are not used to the extent they deserve. This is predominantly due to variable success rates. Furthermore, the existing techniques for placing catheters for CPNBs are technically complicated and time consuming.4,5 Major problems include difficult insertion of the catheter tip past the needle, difficult visualization of catheter advancement, secondary displacement of the local anesthetic (LA) injection orifice(s) and limited possibility of repositioning the catheter once it has been left in situ. We have developed a new catheter for CPNBs to address and overcome these limitations.
Hence, the new catheter should primarily provide precise initial placement of the catheter, less risk of secondary displacement and a possibility to readjust the new catheter at any time point after initial placement. Furthermore, in-plane ultrasound (US) visualization during the entire procedure and during readjustment should be possible. The new catheter should also provide a simple and rapid technique with few components. Initial proof of concept studies in cadavers are promising with success rates close to 100 % both for initial placement and readjustment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lidocainhydrochlorid | Active Comparator | Lidocaine 20mg/ml, 15 ml injected perineural at the sciatic nerve |
|
| Isotonic saline | Placebo Comparator | 0.9% Saline Solution, 15ml injected perineural at the contralateral sciatic nerve |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lidocainhydrochlorid | Drug | Lidocaine injected through the novel Catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Muscle force (dynamometer) change from baseline | Decreased muscle force measured with a dynamometer after intervention | an average of three months |
| Measure | Description | Time Frame |
|---|---|---|
| Surface EMG (sEMG) change from baseline | Decreased EMG response (mV) after intervention | an average of three months |
| Displacement of catheter (mm) change from initial placement | Displacement of catheter in millimeters assessed by ultrasound |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Rothe | Nordsjaellands Hospital | Principal Investigator |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 11, 2020 | |
| Reset | Aug 25, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 11, 2020 | Aug 25, 2020 |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Isotonic Saline | Drug | Isotonic saline injected through the novel Catheter |
|
|
| an average of three months |
| Cutaneous Sensory Mapping (Decreased sensibility in the region innervated by Tibial and Popliteal nerves) change from baseline | Decreased sensibility in the region innervated by Tibial and Popliteal nerves | an average of three months |
| Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |