Duration of Blockade of Peripheral Nerves With Bupivacaine Depending of the Adjuvants

NCT04498923 | Completed

• 1 other identifier: LNMY-FPGE- ANESTHESIOLOGY-DBBA
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain; Peripheral Neuropathy; Fractures of the Upper Limb; Fracture of the Lower Limb (Except Hip), Initial Encounter; Intraoperative Hypotension; Intraoperative Hypertension; Pain Syndrome; Anesthesia; Anesthesia, Local; Local Anesthetic Systemic Toxicity

Keywords

Regional anesthesia; Pain management; Local anesthetic; Electromyography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The amount of narcotic anesthetic used in the postoperative period

  48 hour after surgery

Study Arms (2)

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 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

Interventions

Bupivacaine, dexamethasone, epinephrine DRUG

Bupivacaine 75 mg, dexamethasone 4 mg, epinephrine 0,18 mg

Bupivacaine with dexamethasone; Bupivacaine with dexamethasone and epinephrine

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• All patients undergoing upper or lower extremity orthopedic surgery

You may not qualify if:

• diabetes mellitus;
• diseases of the peripheral nerv system

Sponsors & Collaborators

• Lviv National Medical University: lead

Study Sites (1)

Rivne Oblast State Hospital

Rivne, Rivne Oblast, 33000, Ukraine

Location

Related Links

• ORCID

MeSH Terms

Conditions

Pain, Postoperative; Peripheral Nervous System Diseases; Somatoform Disorders; Agnosia

Interventions

Bupivacaine; Dexamethasone; Epinephrine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Neuromuscular Diseases; Nervous System Diseases; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Maksym Barsa

  Сlinical resident

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 5, 2020
• Study Start: January 1, 2018
• Primary Completion: April 5, 2022
• Study Completion: April 5, 2022
• Last Updated: April 13, 2022

Record last verified: 2022-04

Locations

UA (1)