Magnesium Sulphate in the Ultrasound-guided Supraclavicular Brachial Plexus Block

NCT02752334 | Completed Phase 2 DMC

• 1 other identifier: MEEC-IRB-2016-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluated the motor and sensory block duration and the postoperative analgesic effects of adding Magnesium Sulphate to bupivacaine in the ultrasound-guided supraclavicular brachial plexus block Anesthesia. Motor and sensory block duration were considered as a primary endpoint.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• The sensory block duration (the time interval between the end of local anesthetic administration and restoration of normal sensation) were evaluated as primary endpoint

  extended

  12 hours

Secondary Outcomes (1)

• the postoperative analgesic effects (the time interval between the end of local anesthetic administration and the first analgesia given) as a secondary endpoint.

  12 hours

Study Arms (2)

group Bupivacaine

NO INTERVENTION

patients will receive 23 mL of Bupivacaine HCL 0.5% (Marcaine, 5 mg per mL; Hospira, USA) in addition to 2 mL normal saline using Ultrasound-guided Supraclavicular Brachial Plexus Block

group Bupivacaine Magnesium

ACTIVE COMPARATOR

patients will receive 23 mL of Bupivacaine HCL 0.5% in addition to 2 mL (100 mg) Magnesium Sulphate (Magnesium Sulphate 50 %, 500 mg per mL; Hospira, USA) diluted with normal saline. using Ultrasound-guided Supraclavicular Brachial Plexus Block

Drug: Magnesium Sulphate

Interventions

Magnesium Sulphate DRUG

Magnesium has antinociceptive effects in animal and human models, principally related to blocking the N-methyl-D-aspartate (NMDA) receptors and regulation of calcium influx into cells.

Also known as: Bupivacaine HCL 0.5%

group Bupivacaine Magnesium

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- ASA physical status I to II,
• \- Patients listed for elective forearm or hand surgery using supraclavicular brachial plexus block anesthesia

You may not qualify if:

• evidence of severe cardiovascular, renal, or hepatic diseases, preexisting neurological or psychiatric illnesses.
• patients have allergy to the study drugs. 3 - patients who have any contraindications to brachial plexus block anesthesia.
• pregnant or lactating women, or 5- if the BMI was \> 35 kg/m2.

Sponsors & Collaborators

• Magrabi Eye & Ear Hospital: lead

Study Sites (1)

Tanta University Hospitals

Tanta, 112, Egypt

Location

Related Publications (1)

• Tran DQ, Russo G, Munoz L, Zaouter C, Finlayson RJ. A prospective, randomized comparison between ultrasound-guided supraclavicular, infraclavicular, and axillary brachial plexus blocks. Reg Anesth Pain Med. 2009 Jul-Aug;34(4):366-71. doi: 10.1097/AAP.0b013e3181ac7d18.

  PMID: 19574871 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Ashraf M Ghali, Phd

  Magrabi Eye & Ear Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: proffesor of anesthesia and ICU

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: April 26, 2016
• Study Start: September 1, 2015
• Primary Completion: February 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 8, 2019

Record last verified: 2019-03

Locations

EG (1)