Magnesium Sulphate in the Ultrasound-guided Supraclavicular Brachial Plexus Block

NCT ID: NCT02752334

Last Updated: 2019-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2019-03-31

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.

Detailed Description

The supraclavicular approach to the brachial plexus provides more consistent and effective regional anesthesia to the upper extremity than other approaches to brachial plexus blockade. However, the fear of pneumothorax is often cited by anesthetists as a reason to avoid this approach. With increasing affirmation on patient safety and better patient outcomes, ultrasound guided regional anesthesia (UGRA) is becoming more widely popular. Ultrasound provides clinicians with a real time image suitable for visualizing anatomical structures, needle placement, and local anesthetic spread. Ultrasound-guidance to supraclavicular brachial plexus block has shown to increase success rates, reduce the volume of local anesthetic (LA) used and has the potential to minimize the risk of complications.

Although there are many treatment choices for postoperative pain, a gold standard has not been established. Prolonging the duration of peripheral nerve blocks using long-acting Local Anesthesia or perineural catheters can be used. However, perineural catheters are more time-consuming, costly, has possible higher complication rates (e.g. Infection), and needs more postoperative care.

Several adjuvants such as fentanyl, alpha-2 adrenergic agonists (clonidine or dexmedetomidine), tramadol, and magnesium have been used to extend the duration of peripheral nerve blocks. 5-7 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. Calcium influx leads to a sequence of central sensitization such as windup phenomenon and long term potentiation which are crucial mechanisms that determine the duration and intensity of post-operative pain. Magnesium prevents central sensitization triggered by peripheral nociceptive stimulation in response to painful stimuli.

The investigators designed this study to evaluate the effect of adding magnesium sulphate to bupivacaine in the ultrasound-guided supraclavicular brachial plexus block anesthesia. The sensory and motor block durations were evaluated as primary endpoints and the postoperative analgesic effects as a secondary endpoint.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

group Bupivacaine

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 Type: NO_INTERVENTION

No interventions assigned to this group

group Bupivacaine Magnesium

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

Group Type: ACTIVE_COMPARATOR

Magnesium Sulphate

Intervention Type: 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.

Interventions

Magnesium Sulphate

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.

Intervention Type: DRUG

Other Intervention Names

Bupivacaine HCL 0.5%

Eligibility Criteria

Inclusion Criteria

1. - ASA physical status I to II,

2. - Patients listed for elective forearm or hand surgery using supraclavicular brachial plexus block anesthesia

Exclusion Criteria

1 - evidence of severe cardiovascular, renal, or hepatic diseases, preexisting neurological or psychiatric illnesses.

2- patients have allergy to the study drugs. 3 - patients who have any contraindications to brachial plexus block anesthesia.

4- pregnant or lactating women, or 5- if the BMI was > 35 kg/m2.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Magrabi Eye & Ear Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ashraf M Ghali

proffesor of anesthesia and ICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ashraf M Ghali, Phd

Role: STUDY_CHAIR

Magrabi Eye & Ear Hospital

Locations

Tanta University Hospitals

Tanta, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 19574871 (View on PubMed)

Other Identifiers

MEEC-IRB-2016-1

Identifier Type: -

Identifier Source: org_study_id