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Improving Quality of Bier Block

NCT04393610 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2020-05-21

No results posted yet for this study

Summary

Intravenous regional anesthesia is one of the well-known techniques of regional anesthesia for short surgical operations on the upper and lower limbs. It was first introduced back in 1908. Later on it was popularized even more for the same purpose by using two tourniquets to isolate an exsanguinated extremity then injection of local anesthesia. It was proved over time to be safe and effective with minimal side effects and complications.

Magnesium sulfate (MgSO4) has been used over the 20th century for prevention and treatment of pre-eclamptic and eclampsia seizures during pregnancy because of its superior safety profile over other drugs used for the same purpose. The specific mechanisms of action of magnesium sulfate still unclear but are probably multi-factorial. It may act as a vasodilator on peripheral as well as cerebral vasculature, to decrease peripheral vascular resistance and/or relieve vasoconstriction. Additionally, it may also protect the blood-brain barrier and limit cerebral edema formation, or it may also act as a central anticonvulsant.

Fentanyl; was first introduced back in 1990 for palliative use as fentanyl patch. Few years later, it became available in different forms of administration being highly lipophilic. Few years later it became the most widely used synthetic opioid in medicine. It is an opioid analgesic with a rapid onset and short duration of action. It is a potent μ-opioid receptor pure agonist. Fentanyl is 50 to 100 times more potent than morphine. Fentanyl has a relatively wide therapeutic index, which makes it a very safe surgical anesthetic drug when monitored carefully.

Conditions

  • Analgesia

Interventions

DRUG

Lidocaine

Patients will receive lidocaine 3 mg/kg total of 40 ml (control group).

DRUG

Magnesium Sulphate

Patients will receive lidocaine 3 mg/kg total of 40 ml plus Magnesium sulphate 30 mg/kg maximum 1.5 gm, mixed with the second 20 ml of block solution.

DRUG

Fentanyl

Patients will receive lidocaine 3 mg/kg total of 40 ml plus fentanyl 1 mcg/kg, mixed with lidocaine given after the first 20 ml of block solution.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-14
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04393610 on ClinicalTrials.gov