Clinical trial NCT02198547: Magnesium as Adjuvant for Sciatic Block
Official title: Evaluation of Magnesium as Adjuvant to Ropivacaine for Sciatic Block at Popliteal Level.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hallux Valgus
Keywords: Local anesthetic adjuvant,
Magnesium solfatus,
Sciatic block
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2014-07-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of the study is to evaluate if Magnesium added to ropivacaine can reduce onset time and can enhance offset time.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* given consent
* allux valgus correction surgery

Exclusion Criteria:

* allergy to local anesthetic
* infection in the site of puncture

Primary outcomes:
measure: Evaluation of Mg as adjuvant to local anesthetic
timeFrame: Till 24 hours
Secondary outcomes:
measure: Post-operative pain
timeFrame: 3 hours
measure: Post-operative analgesic consumption
timeFrame: till 24 hours
measure: Post-operative pain
timeFrame: 6 hours
measure: post-operative pain
timeFrame: 12 hours
measure: Post-operative pain
timeFrame: 24 hours
Other outcomes:
measure: Patients' approval
timeFrame: At 24 hours
Locations:
city: Rome
country: Italy
facility: Campus Bio-Medico
Study officials:
affiliation: Campus Bio Medico
name: Massimiliano Carassiti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.