Improving Quality of Bier Block

NCT04393610 | Unknown Phase 2

• 1 other identifier: Quality IVRA
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Magnesium sulphate; Fentanyl; Bier block

Outcome Measures

Primary Outcomes (1)

• VAS score

  Onset of tourniquet pain after deflating proximal tourniquet. VAS consists of a straight line with the endpoints defining extreme limits WHERE 0='no pain AND 10= severe pain.

  2 hours

Secondary Outcomes (4)

• 3-point scale for motor function

  6 hours

• 3-point scale for sensory function

  6 hours

• Total Supplement Analgesia

  24 hours

• Complications

  24 hours

Study Arms (3)

Group (L)

ACTIVE COMPARATOR

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

Drug: Lidocaine

Group M

ACTIVE COMPARATOR

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: Magnesium Sulphate

Group F

ACTIVE COMPARATOR

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.

Drug: Fentanyl

Interventions

Lidocaine DRUG

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

Group (L)

Magnesium Sulphate DRUG

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.

Group M

Fentanyl DRUG

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.

Group F

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• scheduled for short surgical procedures (30 - 60 minutes) distal to elbow
• age 18-55 years old
• ASA I - II
• both genders
• average weight BMI (25 - 35).

You may not qualify if:

• seizure diseases
• allergy to the used medicine
• local infection
• patients with sickle cell anemia, Raynaud's disease, scleroderma, myasthenia gravis, significant cardiac or hepatic diseases.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Lidocaine; Magnesium Sulfate; Fentanyl

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Esam Taher, MD

CONTACT

01002228905; ehamed@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesia and Intensive Care

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 19, 2020
• Study Start: May 14, 2020
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: May 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)