Duration of Blockade of Peripheral Nerves With Bupivacaine Depending of the Adjuvants (DBBA)

Duration of Blockade of Peripheral Nerves With Low Concentrated Bupivacaine Solution Depending of the Adjuvants

The main aim of the investigator's study is to propose combination of local anesthetics and adjuvants that provides both adequate anesthesia during surgery and prolonged post-operative analgesia.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Anesthesia, Local; Anesthesia; Peripheral Neuropathy; Pain Syndrome; Intraoperative Hypotension; Local Anesthetic Systemic Toxicity; Intraoperative Hypertension; Fractures of the Upper Limb; Fracture of the Lower Limb (Except Hip), Initial Encounter
• Intervention / Treatment: Drug: Bupivacaine, dexamethasone, epinephrine

Detailed Description

Peripheral nerve plexuses blocks are performing as a component of analgesia in patients undergoing orthopedic surgery on the upper or lower extremities. Patients are divided into two groups depending on the adjuvant to the local anesthetic: 1st group - patients whose blockade is performed with a solution of bupivacaine 0.375% together with dexamethasone 0.02%; Group 2 - patients whose blockade is performed with a solution of bupivacaine 0.375% together with dexamethasone 0.02% and epinephrine 0.00018%. The duration of the blockade is estimated by puncturing the skin with a needle. The intensity of pain is assessed at 6, 12, 24 and 36 hours after blockade using Visual analog scale (VAS). The amount of narcotic anesthetic used in the postoperative period is also recorded. In addition, patients underwent electromyography of the innervation area of the blocked nerve before the surgery and 24 and 36 hours after surgery.

• Study Type: Observational
• Enrollment (Actual): 68

Contacts and Locations

Study Locations

• Ukraine
  • Rivne Region
    • Rivne, Rivne Region, Ukraine, 33000
      • Rivne Oblast State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing orthopedic surgery on the upper and lower extremities in the Regional Center of Orthopedics, Traumatology and Vertebrology of Rivne Oblast State Hospital

Description

Inclusion Criteria:

• All patients undergoing upper or lower extremity orthopedic surgery

Exclusion Criteria:

• diabetes mellitus;
• diseases of the peripheral nerv system

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bupivacaine with dexamethasone; Ultrasound guided peripheral nerve block for upper or lower extremity was performed before orthopedic surgery using neurostimulator. Twenty milliliters solution of bupivacaine 0,375% with dexamethasone was injected for one plexus or peripheral nerve.	Drug: Bupivacaine, dexamethasone, epinephrine; Bupivacaine 75 mg, dexamethasone 4 mg, epinephrine 0,18 mg
Bupivacaine with dexamethasone and epinephrine; Ultrasound guided peripheral nerve block for upper or lower extremity was performed before orthopedic surgery using neurostimulator. Twenty milliliters solution of bupivacaine 0,375% with dexamethasone 0,02% and epinephrine 0,00018% was injected for one plexus or peripheral nerve.	Drug: Bupivacaine, dexamethasone, epinephrine; Bupivacaine 75 mg, dexamethasone 4 mg, epinephrine 0,18 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The duration of blockade	The duration of the blockade was estimated by puncturing the skin with a needle every hour. In addition, patients underwent electromyography of the innervation area of the blocked nerve before the surgery and 24 and 36 hours after surgery.	6th, 12th, 24th and 36th hours after blockade

Secondary Outcome Measures

Outcome Measure	Time Frame
The amount of narcotic anesthetic used in the postoperative period	48 hour after surgery

Collaborators and Investigators

• Sponsor: Lviv National Medical University
• Investigators: Principal Investigator: Maksym Barsa, Сlinical resident

Publications and helpful links

Helpful Links

• ORCID

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): April 5, 2022
• Study Completion (Actual): April 5, 2022

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: August 2, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Actual): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Pain management; Electromyography; Local anesthetic; Regional anesthesia
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Fractures, Bone; Hypotension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Dexamethasone; Bupivacaine; Epinephrine
• Other Study ID Numbers: LNMY-FPGE- ANESTHESIOLOGY-DBBA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No