Magnesium as Adjuvant for Sciatic Block

Hallux Valgus Clinical Trial

— Mg  

Official title:

Evaluation of Magnesium as Adjuvant to Ropivacaine for Sciatic Block at Popliteal Level.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02198547
• Other study ID #: CarGalMg
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 2014
• Est. completion date: September 2022

Study information

• Verified date: January 2021
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: September 2022
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• given consent

• allux valgus correction surgery

Exclusion Criteria:

• allergy to local anesthetic

• infection in the site of puncture

Related Conditions & MeSH terms

• Hallux Valgus

Intervention

Drug:
• Magnesium Sulfate
Mg used with ropivacaine for sciatic nerve blick
• Ropivacaine
Ropivacaine 7,5 mg/ml used for sciatic nerve block

Locations

Country	Name	City	State
Italy	Campus Bio-Medico	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patients' approval	We evaluate the grade of approval of patients with a questionnaire	At 24 hours
Primary	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
Secondary	Post-operative pain	We evaluate post-operative pain at rest and in movement at 3-6-12-24 hours with NRS scale	3 hours
Secondary	Post-operative analgesic consumption	We evaluate consumption of opioid and non-opioid analgesic used in the post-operative period.	till 24 hours
Secondary	Post-operative pain	Evaluation of pain with NRS scale	6 hours
Secondary	post-operative pain	Evaluation of pain with NRS scale	12 hours
Secondary	Post-operative pain	Evaluation of pain with NRS scale	24 hours