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The aim of the study is to evaluate if Magnesium added to ropivacaine can reduce onset time and can enhance offset time.
Patients are randomly divided into two groups: group "M" (Ropivacaina 7,5 mg/ml with Mg 4 mg/Kg)and group"C" (without Mg).
Standard monitoring is applied to each patient in perioperative period. An indipendent observer collect data: time to perform block, sensitivity onset,motor onset, pain during surgery and complication.
In the post-operative period till 24 hours for each patient is evaluated off-set time, pain and analgesic consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine Magnesium sulfate | Experimental | Locoregional anesthesia for valgus allux correction with ropivacaine 7,5 mg/ml and Mg 4 mg/Kg. Sciatic block at popliteal level. |
|
| Ropivacaine | Active Comparator | Patients undergoing allux valgus correction with locoregional anesthesia with ropivacaine 7,5 mg/ml, without MG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Sulfate | Drug | Mg used with ropivacaine for sciatic nerve blick |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Mg as adjuvant to local anesthetic | We evaluate if Mg affects onset and offset time of ropivacaine 7,5 mg/ml in sciatic block at popliteal level | Till 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pain | We evaluate post-operative pain at rest and in movement at 3-6-12-24 hours with NRS scale | 3 hours |
| Post-operative analgesic consumption | We evaluate consumption of opioid and non-opioid analgesic used in the post-operative period. |
| Measure | Description | Time Frame |
|---|---|---|
| Patients' approval | We evaluate the grade of approval of patients with a questionnaire | At 24 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Massimiliano Carassiti, MD | Campus Bio Medico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Campus Bio-Medico | Rome | 00128 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22012543 | Background | Lee AR, Yi HW, Chung IS, Ko JS, Ahn HJ, Gwak MS, Choi DH, Choi SJ. Magnesium added to bupivacaine prolongs the duration of analgesia after interscalene nerve block. Can J Anaesth. 2012 Jan;59(1):21-7. doi: 10.1007/s12630-011-9604-5. Epub 2011 Oct 20. | |
| 22696144 | Background | Ekmekci P, Bengisun ZK, Akan B, Kazbek BK, Ozkan KS, Suer AH. The effect of magnesium added to levobupivacaine for femoral nerve block on postoperative analgesia in patients undergoing ACL reconstruction. Knee Surg Sports Traumatol Arthrosc. 2013 May;21(5):1119-24. doi: 10.1007/s00167-012-2093-4. Epub 2012 Jun 14. |
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| ID | Term |
|---|---|
| D006215 | Hallux Valgus |
| ID | Term |
|---|---|
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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| Ropivacaine |
| Drug |
Ropivacaine 7,5 mg/ml used for sciatic nerve block |
|
| till 24 hours |
| Post-operative pain | Evaluation of pain with NRS scale | 6 hours |
| post-operative pain | Evaluation of pain with NRS scale | 12 hours |
| Post-operative pain | Evaluation of pain with NRS scale | 24 hours |
| 23094900 | Background | Dogru K, Yildirim D, Ulgey A, Aksu R, Bicer C, Boyaci A. Adding magnesium to levobupivacaine for axillary brachial plexus block in arteriovenous fistule surgery. Bratisl Lek Listy. 2012;113(10):607-9. doi: 10.4149/bll_2012_136. |
| 23138572 | Background | Vastani N, Seifert B, Spahn DR, Maurer K. Sensitivities of rat primary sensory afferent nerves to magnesium: implications for differential nerve blocks. Eur J Anaesthesiol. 2013 Jan;30(1):21-8. doi: 10.1097/EJA.0b013e32835949ab. |
| 24534592 | Background | Bailard NS, Ortiz J, Flores RA. Additives to local anesthetics for peripheral nerve blocks: Evidence, limitations, and recommendations. Am J Health Syst Pharm. 2014 Mar 1;71(5):373-85. doi: 10.2146/ajhp130336. |
| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |